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    Summary
    EudraCT Number:2018-000285-10
    Sponsor's Protocol Code Number:CCS1477-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-000285-10
    A.3Full title of the trial
    An open-label Phase I/IIa study to evaluate the safety and efficacy of CCS1477 as monotherapy and in combination, in patients with advanced solid/metastatic tumours.
    Estudio abierto de fase I/IIa para evaluar la seguridad y eficacia de
    CCS1477 en monoterapia y en combinación en pacientes con tumores
    sólidos avanzados/metastásicos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A first time in man study to look at the safety of the experimental drug CCS1477 and see what effects it has on patients with advanced tumours
    Primer estudio en humanos para evaluar la seguridad del fármaco experimental CCS1477 y ver sus efectos en pacientes con tumores sólidos avanzados.
    A.3.2Name or abbreviated title of the trial where available
    Phase I/IIa study to evaluate CCS1477 in advanced tumours v1.0
    Estudio fase I/IIa para evaluar CCS1477 en tumores avanzados v1.0
    A.4.1Sponsor's protocol code numberCCS1477-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03568656
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCellCentric Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCellCentric Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCellCentric Ltd
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressChesterfordResearch Park
    B.5.3.2Town/ cityLittle Chesterford
    B.5.3.3Post codeCB10 1XL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01799531130
    B.5.5Fax number01799531099
    B.5.6E-mailwill.west@cellcentric.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code CCS1477 25 mg
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCCS1477
    D.3.9.2Current sponsor codeCCS1477-M
    D.3.9.3Other descriptive nameInhibitor of the bromodomain of p300 & CBP
    D.3.9.4EV Substance CodeSUB193153
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCCS1477
    D.3.9.2Current sponsor codeCCS1477-MB
    D.3.9.3Other descriptive nameCCS1477
    D.3.9.4EV Substance CodeSUB193153
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Abiraterone acetate
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAbiraterone acetate [250 mg]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABIRATERONE
    D.3.9.1CAS number 154229-18-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameABIRATERONE ACETATE
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Enzalutamide
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEnzalutamide
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENZALUTAMIDE
    D.3.9.1CAS number 915087-33-1
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Enzalutamide
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEnzalutamide
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENZALUTAMIDE
    D.3.9.1CAS number 915087-33-1
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 5
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code CCS1477 10 mg
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCCS1477
    D.3.9.2Current sponsor codeCCS1477-M
    D.3.9.3Other descriptive nameInhibitor of the bromodomain of p300 & CBP
    D.3.9.4EV Substance CodeSUB193153
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCCS1477
    D.3.9.2Current sponsor codeCCS1477-MB
    D.3.9.3Other descriptive nameCCS1477
    D.3.9.4EV Substance CodeSUB193153
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 6
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Abiraterone acetate
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAbiraterone acetate [500 mg]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABIRATERONE
    D.3.9.1CAS number 154229-18-2
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameABIRATERONE ACETATE
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic Castrate Resistant Prostate Cancer (mCRPC) and other advanced cancers with solid tumours.
    Cáncer de próstata metastásico resistente a la castración (mCRPC) y otros cánceres avanzados con tumores sólidos.
    E.1.1.1Medical condition in easily understood language
    Prostate cancer that has spread to other parts of the body beyond the prostate and continues to spread despite the use of hormone therapy.
    Cancers which have solid tumours.
    Cáncer de próstata que se ha diseminado a otras partes del cuerpo más allá de la próstata y continúa diseminándose a pesar del uso de terapia hormonal.
    Cánceres que tienen tumores sólidos.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the safety and tolerability of CCS1477 given alone and in combination with abiraterone or enzalutamide.

    Investigar la seguridad y tolerabilidad de CCS1477 en monoterapia y en combinación con abiraterona o enzalutamida.
    E.2.2Secondary objectives of the trial
    To investigate the efficacy of CCS1477 given alone and in combination with abiraterone or enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC).

    To understand how the body handles the study medication (pharmacokinetics) of CCS1477, following a single dose and after multiple dosing, when given on its own or in combination with abiraterone or enzalutamide.

    To understand the pharmacokinetics of abiraterone, enzalutamide and N-desmethyl enzalutamide when dosed in combination with CCS1477.

    To investigate the efficacy of CCS1477 in cancer patients with solid tumours with molecular markers which may indicate potential for response to p300/CBP inhibition.
    Investigar la eficacia de CCS1477 en monoterapia y en combinación con abiraterona o enzalutamida en pacientes con cáncer de próstata metastásico resistente a la castración (mCRPC).
    Comprender cómo maneja el cuerpo la medicación del estudio (farmacocinética) de CCS1477, después de una dosis única y después de dosis múltiples, cuando se administra solo o en combinación con abiraterona o enzalutamida.
    Comprender la farmacocinética de abiraterona, enzalutamida y Ndesmetil enzalutamida cuando se administran en combinación con CCS1477.
    Investigar la eficacia de CCS1477 en pacientes con cáncer con tumores sólidos con marcadores moleculares que pueden indicar un potencial de respuesta a la inhibición de p300 / CBP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent; willing and and able to comply with study protocol procedures
    3. ≥ 18 years
    4. ECOG performance status 0-1 with no deterioration over previous 2 weeks and minimum life expectancy of 12 weeks
    5. Adequate organ functions:
    • AST/ALT ≤3 x ULN or AST/ALT ≤5 x ULN
    • Total bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, patients with borderline elevation due to underlying liver involvement may be eligible).
    • Calculated creatinine clearance by Cockcroft-Gault formula ≥30 ml/min²
    • ANC ≥1.5 x 109/L
    • Platelets ≥100 x 109/L
    • Haemoglobin ≥9g/dL
    6. For duration of the study and 1 week after the last study administration, sexually active male patients must be willing to use barrier contraception with all sexual partners. Where the sexual partner is a ‘woman of child-bearing potential’ who is not using effective contraception, men must use a condom and another form of contraception during the study and for 3 months after the last dose of study medication.
    7. Females must agree to use highly effective contraceptive measures, must not be breast feeding and must have a negative serum pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential at screening per one of:
    • Post menopausal defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments
    • Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
    • Amenorrhoeic for 12 months and serum FSH, LH and plasma oestradiol levels in the postmenopausal range for institution
    8. Patients must have assessable disease (by CT, MRI, bone scan or X-ray) but are not required to have measurable disease

    Additional inclusion criteria for Parts A, B, C & D (mCRPC)
    9. Patients must have previously received:
    • abiraterone and/or enzalutamide (or equivalent anti-androgen), and
    • a taxane (unless ineligible or refused)
    10. Progressive disease documented by one or more of:
    • Biochemical progression defined as at least 2 stepwise increases in a series of any 3 PSA values collected while the patient has castrate levels of testosterone. The 3 PSA values selected do not need to be consecutive, and do not need to include the most recent PSA collected at, or prior to, study enrolment, but must meet the following criteria:
    a. PSA progression defined by minimum of 3 rising PSA levels with an interval of ≥1 week between each determination
    b. Each of the 3 PSA values must be collected while the patient is under medical castration or is surgically castrated
    c. Ideally all 3 should be done after anti-androgen withdrawal (if applicable), but they can be done during the withdrawal period
    • Progression as defined by RECIST v1.1 guideline for assessment of malignant soft tissue disease or modified RECIST v1.1 criteria as defined by PCWG-3 for progression of nodes
    • Progression defined as 2 or more new metastatic bone lesions confirmed on bone scan from a previous assessment
    11. PSA at screening must be ≥2 μg/L (2 ng/mL)
    12. Serum testosterone concentration ≤50 ng/dL sustained by medical or surgical castration
    13. Serum albumin >2.5 g/dL

    Additional Part C inclusion criteria (CCS1477 plus abiraterone)
    14. Patients must have previously progressed on abiraterone treatment
    15. Patients whose last dose of abiraterone is >6 months prior to start of study treatment will receive a 4-week run-in treatment with abiraterone to confirm refractoriness to abiraterone treatment

    Additional Part D inclusion criteria (CCS1477 plus enzalutamide)
    16. Patients must have previously progressed on enzalutamide treatment
    17. Patients whose last dose of enzalutamide is >6 months prior to start of study treatment will receive a 4-week run-in treatment with enzalutamide to confirm refractoriness to enzalutamide treatment. All patients in drug-drug interaction (DDI) arm will receive enzalutamide monotherapy during Cycle 0

    Additional Part E inclusion criteria (non-prostate only)
    18. Histological or cytological confirmation of malignancy that is advanced. Patients must be refractory to, or intolerant of, or refusing existing therapies known to provide clinical benefit for their condition
    19. Identification of markers which may indicate potential for response to p300/CBP inhibition will be determined by local testing and will include, but not be limited to, loss of function mutations in either p300 or CBP and/or Myc amplification or over-expression, determined by next generation sequencing in tumour biopsies/cell free DNA extracted from a pre-treatment blood sample. IHC may also be used, as appropriate, to determine over expression of proteins such as myc or AR. Patients with certain cancers where molecular testing has not been performed may be eligible upon discussion with medical monitor.
    1.Proporcionar consentimiento informado por escrito firmado y fechado
    2.Dispuesto y ser capaz de cumplir los procedimientos del protocolo del estudio
    3.≥18años
    4.Puntuación 0-1 en la escala del estado funcional del ECOG sin deterioro en las 2sem anteriores y esperanza de vida mínima de 12sem
    5.Funciones orgánicas aceptables: AST/ALT ≤3veces LSN o AST/ALT ≤5 veces LSN (metástasis hepáticas subyacentes); Bilirrubina total ≤1,5veces LSN (a menos que se deba al síndrome de Gilbert o tenga origen extrahepático, pacientes con elevación limítrofe por afectación hepática subyacente pueden ser aptos); Aclaramiento de creatinina calculado con la fórmula de Cockcroft-Gault ≥30ml/min2; RAN ≥1,5×109/l; Plaquetas ≥100×109/l; Hemoglobina ≥9g/dl
    6.Durante todo el estudio y hasta 1sem tras la última dosis del medicamento del estudio, pacientes varones sexualmente activos deben estar dispuestos a utilizar un método anticonceptivo de barrera con todas las parejas sexuales. Cuando la pareja sexual sea una “mujer con capacidad de procrear” que no utilice métodos anticonceptivos eficaces, los hombres deben usar un preservativo y otro anticonceptivo durante el estudio y 3meses tras la última dosis
    7.Mujeres deben aceptar el uso de métodos anticonceptivos eficaces, no deben estar amamantando y deben tener un resultado negativo en una prueba de embarazo en suero antes de empezar el tratamiento si pueden quedar embarazadas, o debe tener evidencia de potencial no fértil: Posmenopáusica (tener más de 50 años y amenorrea durante ≥12meses tras el cese de tratamientos hormonales exógenos); Documentación de esterilización quirúrgica irreversible (histerectomía, ooforectomía bilateral o salpingectomía bilateral, pero no ligadura de trompas); o Amenorrea durante 12meses y niveles séricos de FSH, LH y estradiol en plasma en el rango posmenopáusico
    8.Presentar enfermedad evaluable (TAC, RM, gammagrafía ósea o radiografía) pero no es necesario enfermedad mensurable (criterios RECIST v1.1).

    Criterios adicionales partes A, B, C, D:
    9.Haber recibido previamente: abiraterona y/o enzalutamida (o antiandrógeno equivalente) y un taxano (salvo que no fuera elegible o lo rechazara)
    10.Progresión de la enfermedad documentada por uno o más de los siguientes:
    •Progresión bioquímica definida como al menos 2 aumentos progresivos en una serie de 3 valores de PSA obtenidos mientras el paciente presenta niveles de testosterona de castración. No es necesario que los 3 sean consecutivos, y no es necesario incluir el valor más reciente en el momento la inclusión o con anterioridad, pero deben cumplir: Progresión de PSA definida por un mínimo de 3 niveles de PSA en aumento con un intervalo de ≥1sem entre cada uno; Cada uno de los valores de PSA debe obtenerse mientras el paciente esté sometido a castración médica o si se le ha sometido a castración quirúrgica; Idealmente, los 3 deben obtenerse tras la retirada del antiandrógeno, pero pueden obtenerse durante el período de retirada.
    •Progresión según los criterios RECIST v1.1 para la evaluación de la malignidad en los tejidos blandos o criterios RECIST modificados v1.1 definidos por el PCWG-3 para la progresión en los ganglios.
    •Progresión definida como 2 o más lesiones óseas metastásicas nuevas confirmadas en gammagrafía ósea de una evaluación anterior.
    11.Valor de PSA en la selección ≥2μg/l (2ng/ml)
    12.Concentración de testosterona sérica ≤50ng/dl mantenida por castración médica o quirúrgica
    13.Albúmina sérica >2,5g/dl

    Criterios adicionales parte C
    14.Haber presentado progresión previamente durante el tratamiento con abiraterona
    15.Si la última dosis de abiraterona fue >6meses antes del inicio del tratamiento del estudio recibirán un tratamiento de preinclusión de 4sem con abiraterona para confirmar la resistencia a la misma, según lo determinado por investigador y monitor médico

    Criterios adicionales parte D
    16.Haber experimentado progresión previa durante el tratamiento con enzalutamida
    17.Si la última dosis de enzalutamida fue >6meses antes del inicio del tratamiento del estudio recibirán un tratamiento de preinclusión de 4sem con enzalutamida para confirmar la resistencia a la misma, según lo determinado por investigador y monitor médico. Todos los pacientes del grupo de interacción farmacológica recibirán enzalutamida en monoterapia durante el ciclo 0

    Criterios adicionales parte E
    18.Confirmación histológica o citológica de neoplasia maligna avanzada. Deben presentar resistencia o intolerancia a los tratamientos existentes que proporcionan beneficio clínico a su enfermedad
    19.Identificación de marcadores que puedan indicar posible respuesta a la inhibición de p300/CBP (mutaciones por pérdida de función en p300 o CBP y/o amplificación o sobreexpresión de Myc, entre otros) mediante pruebas locales (secuenciación de última generación o equivalente) en biopsias tumorales recientes o de archivo o en ADN extracelular circulante de una muestra de sangre antes del tratamiento
    E.4Principal exclusion criteria
    All Patients:
    1. Intervention with any of the following
    • Any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives (whichever is longer of these two) of the first dose of study treatment (excludes treatment with immunotherapy agents which must be assessed on a case by case basis). This does not apply to prior treatment with abiraterone for patients in Part C1 or C2 or prior treatment with enzalutamide for patients in Part D1 (except patients in the DDI arm who must have a 4 week washout of enzalutamide prior to starting the study) and D2.
    • Radiotherapy with a wide field of radiation or to more than 30% of the bone marrow within 4 weeks of the first dose of study treatment
    • Major surgical procedure or significant traumatic injury as judged by the investigator, within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study
    • Strong inducers of CYP3A4 (See Appendix E) taken within 4 weeks of the first dose of study treatment or while on study treatment (excluding enzalutamide in Part D1 and D2 which does not require a 4 week wash-out prior to the first dose of study treatment, except for patients in the DDI arm).
    • Strong inhibitors of CYP3A4. CYP3A4 substrates with a narrow therapeutic range, CYP2C8 or CYP3A4 sensitive substrates (See Appendix E) taken within 2 weeks of the first dose of study treatment or while on study treatment.
    • Washout periods may be reduced for specific medications (eg. statins) following discussion with the medical monitor.
    • Herbal medications cannot be taken within 7 days of the first dose of study treatment (4 weeks for St John’s wort) or while on study treatment
    • Statins; patients should discontinue statins 5 half-lives prior to starting study treatment
    2. Any unresolved reversible toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment with the exception of alopecia and neuropathy
    3. Female patients who are pregnant or breast-feeding at study entry
    4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator’s opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol, or active infection* including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). *Active viral infection is defined as requiring antiviral therapy. Screening for chronic conditions is not required
    5. Patients with any known uncontrolled inter-current illness including ongoing or active clinically significant infections, symptomatic congestive heart failure, hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
    6. Repeatable QTcF prolongation (>480 msec)
    7. Prior malignancy that could affect compliance with the protocol or interpretation of results. Patients with a history of non-melanoma skin cancers or carcinoma in situ treated with curative intent, are generally eligible
    8. Primary brain tumours or known or suspected brain metastases. Patients with brain metastases could be eligible if treated and stable within 28 days of the first dose of study treatment (after discussion and agreement with the CellCentric medical advisor).
    9. Patients with any known severe allergies to any active or inactive ingredients in the study medications

    Additional exclusion criteria for patients in CCS1477 plus abiraterone combination arm (Part C)
    10. Patients with clinically significant cardiac abnormalities as assessed by the treating physician that may include (but not be limited to) recent myocardial infarction (≤6 months) or unstable angina (≤3 months), New York Heart association (NYHA) class III or IV heart failure except if LVEF is ≥50%, clinically significant uncontrolled rhythm disturbances, and patients with uncontrolled hypertension

    Additional exclusion criteria for patients in CCS1477 plus enzalutamide combination arm (Part D)
    11. History of seizures or other predisposing factors including, but not limited to, underlying brain injury, stroke, primary brain tumours, brain metastases and leptomeningeal disease, or alcoholism
    12. Use of substrates with a narrow therapeutic index metabolised by CYP2C9 or CYP2C19 within 2 weeks of the first dose of study treatment
    13. Patients with clinically significant cardiac abnormalities as assessed by the treating physician that may include (but not be limited to) recent myocardial infarction (≤6 months) or unstable angina (≤3 months), New York Heart association (NYHA) class III or IV heart failure except if LVEF is ≥50%, clinically significant uncontrolled rhythm disturbances, and patients with uncontrolled hypertension
    1.Intervención con cualquiera de los siguientes
    •Quimioterapia, fármaco en investigación u otros antineoplásicos en un plazo de 14d o 5 semividas (el período más prolongado de estos dos) antes de la 1ª dosis del tratamiento del estudio (excluye la inmunoterapia que debe evaluarse caso por caso). Esto no aplica al tratamiento previo con abiraterona para pacientes de la parte C1 o C2 o al tratamiento previo con enzalutamida para pacientes de la parte D1 (excepto los del grupo de IF que deben tener un reposo farmacológico de 4sem de enzalutamida antes de comenzar el estudio) y D2
    •Radioterapia con un campo amplio de radiación o más del 30% de la médula ósea en las 4sem previas a la 1ª dosis del tratamiento del estudio
    •Cirugía mayor o lesión traumática significativa a criterio del investigador, en las 4sem previas a la 1ª dosis del tratamiento del estudio, o que tengan una necesidad prevista de cirugía mayor durante el estudio
    •Inductores potentes de la isoenzima CYP3A4 administrados en las 4sem previas a la 1ª dosis o durante el tratamiento del estudio (excepto enzalutamida en las partes D1 y D2, que no requiere periodo de reposo farmacológico, excepto en los pacientes del grupo de IF)
    •Inhibidores potentes de la isoenzima CYP3A4, sustratos de la isoenzima CYP3A4 con margen terapéutico estrecho, o sustratos sensibles de las isoenzimas CYP2C8 o CYP3A4 administrados en las 2sem previas a la 1ª dosis o durante el tratamiento del estudio
    •Períodos de reposo farmacológico pueden reducirse en caso de medicamentos específicos (ej. estatinas) tras comentarlo con el monitor médico
    •Medicamentos a base de hierbas no pueden tomarse en los 7d antes de la 1ª dosis (4sem para la hierba de San Juan) o durante el tratamiento del estudio
    •Deben suspender la administración de estatinas, 5 semividas antes del inicio del tratamiento del estudio
    2.Toxicidad reversible no resuelta por un tratamiento previo superior a grado 1 de los Criterios CTCAE en el momento de iniciar el tratamiento del estudio, excepto alopecia y neuropatía.
    3.Embarazadas o en periodo de lactancia en el momento de la inclusión en el estudio.
    4.Cualquier signo de enfermedades sistémicas graves o no controladas: la hipertensión no controlada y las diátesis hemorrágicas activas, que, en opinión del investigador, hacen inadecuado que el paciente participe en el estudio o ponen en peligro el cumplimiento del protocolo; infección activa* incluyendo hepatitis B, hepatitis C e infección por VIH. *La infección vírica activa se define como la necesidad de tratamiento antivírico. No se requieren pruebas de detección sistemática para afecciones crónicas.
    5.Cualquier enfermedad actual no controlada conocida, incluidas infecciones en curso o clínicamente significativas, insuficiencia cardíaca congestiva sintomática, hipertensión, angina de pecho inestable, arritmia cardíaca o situaciones psicosociales que limiten el cumplimiento del protocolo.
    6.Prolongación del intervalo QTcF repetible (>480ms)
    7.Neoplasia maligna previa que podría afectar al cumplimiento del protocolo o a la interpretación de los resultados. Pacientes con antecedentes de cáncer de piel no melanocítico o carcinoma in situ tratados con intención curativa son elegibles por lo general.
    8.Tumores cerebrales primarios o sospecha de metástasis cerebrales conocidas o sospechadas. Pacientes con metástasis cerebral podrían ser elegibles si fueron tratados y están estables en los 28d previos a la 1ª dosis del tratamiento del estudio (tras comentarlo y consensuarlo con el asesor médico CellCentric).
    9.Pacientes con alergias graves conocidas a cualquiera de los principios activos o inactivos de los medicamentos del estudio

    Criterios adicionales parte C:
    10.Pacientes con anomalías cardíacas clínicamente significativas evaluadas por el médico encargado del tratamiento, incluyendo (entre otras) infarto de miocardio reciente (≤6meses) o angina inestable (≤3meses), insuficiencia cardíaca de clase III o IV de la New York Heart Association (NYHA), excepto si FEVI es ≥50%, trastornos del ritmo no controlados clínicamente significativos y pacientes con hipertensión no controlada

    Criterios adicionales parte D:
    11 Antecedentes de convulsiones u otros factores predisponentes como, entre otros, daño cerebral subyacente, ictus, tumores cerebrales primarios, metástasis cerebrales y enfermedad leptomeníngea, o alcoholismo.
    12.Uso de sustratos con índice terapéutico estrecho metabolizadas por las isoenzimas CYP2C9 o CYP2C19 en las 2sem siguientes a la 1ª dosis del tratamiento del estudio
    13.Pacientes con anomalías cardíacas clínicamente significativas evaluadas por el médico encargado del tratamiento, incluyendo (entre otras) infarto de miocardio reciente (≤6meses) o angina inestable (≤3meses), insuficiencia cardíaca de clase III o IV de la New York Heart Association (NYHA), excepto si FEVI es ≥50%, trastornos del ritmo no controlados clínicamente significativos y pacientes con hipertensión no controlada
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for the study is:

    Safety and tolerability of CCS1477 as monotherapy and in combination with abiraterone and enzalutamide.

    Safety and tolerability will be assessed in terms of AEs, laboratory data, vital signs and ECG changes. These will be collected for all patients. Appropriate summaries of these data will be presented.

    La medida de resultado principal del estudio es:
    Seguridad y tolerabilidad de CCS1477 en monoterapia y en combinación con abiraterona y enzalutamida.
    La seguridad y la tolerabilidad se evaluarán en términos de
    acontecimientos adversos, datos de laboratorio, signos vitales y cambios en el ECG. Estos se recopilarán para todos los pacientes. Se presentarán resúmenes apropiados de estos datos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    AEs will be discussed and recorded at every visit.

    Blood and urine samples for clinical chemistry, haematology, and urinalysis (dipstick) parameters will be taken at the following time-points: Screening, Cycle 1 – D1, D8, D15, D22, Cycle 2 onwards – Day 1 of every cycle, Treatment discontinuation and the 28 day follow up.

    Blood pressure, heart rate, respiration rate and temperature will be recorded at the following timepoints: Screening, Cycle 1 – Every visit (D1, D2, D8, D15, D22) – pre-dose, Cycle 2 onwards – Day 1 of every cycle and Treatment discontinuation.

    12-lead ECGs will be performed at the following timepoints: Screening, Cycle 1 – D1 pre-dose and D8 pre-dose, Cycle 2 onwards – – Day 1 of every cycle, Treatment discontinuation and the 28 day follow up.
    Los AA se analizarán y registrarán en cada visita.
    Muestras de sangre para bioquímica, hematología, y de orina para su análisis (tira reactiva) en: screening, Ciclo 1-D1, D8, D15, D22, Ciclo 2 en adelante-Día 1 de cada ciclo, suspensión de tratamiento y seguimiento a los 28 días.
    La presión arterial, frecuencia cardíaca, frecuencia respiratoria y temperatura se registrarán en: screening, Ciclo 1 - Cada visita (D1, D2, D8, D15, D22) (Predosis), Ciclo 2 en adelante-Día 1 de cada ciclo y suspensión de tratamiento.
    Los ECG de 12 derivaciones se realizarán en: screening, ciclo 1: predosis D1 y predosis D8, ciclo 2 en adelante: día 1 de cada ciclo, suspensión de tratamiento y seguimiento de 28 días.
    E.5.2Secondary end point(s)
    Anti-tumour activity of CCS1477 as monotherapy or in combination with abiraterone or enzalutamide in patients with mCRPC.

    Anti-tumour activity defined by measurement of changes in:
    • circulating prostate-specific antigen (PSA).
    • circulating tumour cells (CTCs).
    • malignant soft tissue response rate (Response Evaluation Criteria in Solid Tumours [RECIST] v1.1).
    • metastatic bone disease status (Prostate Cancer Clinical Trial Working Group 3 [PCWG-3] bone scan criteria).

    To characterise the pharmacokinetics (PK) of CCS1477, following a single dose and at steady state after multiple dosing, when given as a single agent or in combination.

    To characterise the PK of abiraterone, enzalutamide and N-desmethyl enzalutamide when dosed in combination with CCS1477.

    Anti-tumour activity of CCS1477 in patients with p300 or CBP mutation positive tumours by measurement of changes in CTCs and response rate (RECIST v1.1 or appropriate tumour specific response criteria as appropriate).

    To obtain a preliminary assessment of the efficacy of CCS1477 as monotherapy and in combination with abiraterone or enzalutamide by evaluation of radiological progression free survival (rPFS) and overall survival (OS).
    Actividad antitumoral de CCS1477 en monoterapia o en combinación con abiraterona o enzalutamida en pacientes con mCRPC.
    Actividad antitumoral definida por la medición de cambios en:
    • antígeno prostático específico circulante (PSA).
    • células tumorales circulantes (CTC).
    • Tasa de respuesta de tejidos blandos malignos (Criterios de evaluación de respuesta en tumores sólidos [RECIST] v1.1).
    • estado de enfermedad ósea metastásica (criterios de gammagrafía ósea del Grupo de trabajo 3 del ensayo clínico de cáncer de próstata [PCWG-3]).
    Caracterizar la farmacocinética (PK) de CCS1477, después de una dosis única y en estado estacionario después de dosis múltiples, cuando se administra como agente único o en combinación.
    Caracterizar la PK de abiraterona, enzalutamida y Ndesmetilenzalutamida cuando se administran en combinación con CCS1477.
    Actividad antitumoral de CCS1477 en pacientes con tumores positivos para la mutación p300 o CBP mediante la medición de los cambios en las CTC y la tasa de respuesta (RECIST v1.1 o criterios de respuesta específicos del tumor apropiados, según corresponda).
    Obtener una evaluación preliminar de la eficacia de CCS1477 en monoterapia y en combinación con abiraterona o enzalutamida mediante la evaluación de la supervivencia libre de progresión radiológica (SLPr) y la supervivencia global (SG).
    E.5.2.1Timepoint(s) of evaluation of this end point
    PSA:Scr, C1 - D1, D8, D15 & D22, C2 + D1 of every Cycle & treatment discontinuation

    CTC:Scr, D1 C1; pre-dose, D1 C2; pre-dose, D1 C3; pre-dose, D1 C5; pre-dose & at progression or treatment discontinuation

    PK Blood-A, B, C, D & E
    C1 D1, 2 & 3
    Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10, 24 -D2 & 48hr -D3 pre-dose
    C1 D8 & 9 (A, B & E only) and C2 D1 & 2 (A, B, C, D & E)
    Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10 & 24hr - pre-dose

    DDI cohort
    C0 D1, C0 D29, C1 D1-2, C2 D3-4: Pre-dose, 0.5, 1, 1.5, 2, 4, 8, 10, 24 hours

    PK Urine:0-6, 6-12 & 12-24 hrs after dosing on D8/9 of C1 - A, B & E

    CT/MRI & Bone Scan:BL, every 8 wks after D1 for 24 wks, then every 12 wks until progression

    OS until sufficient data collected
    PSA: Scr, C1 - D1, D8, D15 y D22, C2 + D1 de cada ciclo y suspensión del tratamiento
    CTC: Scr, D1 C1; predosis, D1 C2; predosis, D1 C3; predosis, D1 C5; antes de la dosis y en la progresión o interrupción del tratamiento
    PK Blood-A, B, C, D y E
    C1 D1, 2 y 3: predosis, 0.5, 1, 1.5, 2, 4, 8, 10, 24 -D2 y 48hr -D3
    (predosis)
    C1 D8 y 9 (solo A, B y E) y C2 D1 y 2 (A, B, C, D y E): predosis, 0.5, 1, 1.5, 2, 4, 8, 10 y 24 h (predosis)
    Cohorte DDI: C0 D1, C0 D29, C1 D1-2, C2 D3-4: Predosis, 0.5, 1, 1.5, 2, 4, 8, 10, 24 hr
    PK Orina: 0-6, 6-12 y 12-24 hr después de la dosificación en D8/9 de C1 - A, B y E
    TAC/RM y gammagrafía ósea: basal, cada 8 sem después de D1 durante 24 sem, luego cada 12 sem hasta la progresión
    Supervivencia global hasta que se recopilen datos suficientes
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    France
    Germany
    Netherlands
    Spain
    Sweden
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the later of the last patient completing study treatment and the 28-day follow-up visit or 9 months after the last patient has been enrolled. Overall survival will be collected for patients and collection of this data may continue after the last patient has completed study treatment.
    El final del estudio se define como el último paciente que completó el tratamiento del estudio y la visita de seguimiento de 28 días o 9 meses después de que se haya inscrito al último paciente, lo último que ocurra. Se recopilará la supervivencia general de los pacientes y la recopilación de estos datos puede continuar después de que el último paciente haya completado el tratamiento del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 185
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 250
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will be treated until disease progression or until they withdraw from the study. Arrangements for care after the study has ended will be discussed with their Doctor.
    Los pacientes serán tratados hasta la progresión de la enfermedad o hasta que se retiren del estudio. Los arreglos para la atención una vez finalizado el estudio se analizarán con su médico.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-07
    P. End of Trial
    P.End of Trial StatusCompleted
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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