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    Summary
    EudraCT Number:2016-001848-20
    Sponsor's Protocol Code Number:ENGOT-EN3-NSGO/PALEO
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-02-13
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-001848-20
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, phase II trial of Palbociclib in combination with Letrozole versus Placebo in combination with Letrozole for patients with Estrogen Receptor Positive advanced or recurrent Endometrial cancer.
    ENGOT-EN3-NSGO/PALEO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ENGOT-EN3-NSGO/PALEO: A randomized double-blind, placebo-controlled trial comparing letrozole in combination with placebo or in combination with palbociclib in patients with endometrial cancer.
    A.3.2Name or abbreviated title of the trial where available
    ENGOT-EN3-NSGO/PALEO
    A.4.1Sponsor's protocol code numberENGOT-EN3-NSGO/PALEO
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02730429
    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 SponsorNordic Society of Gynaecological Oncology (NSGO)-CTU
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNSGO
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportPfizer
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNSGO-CTU
    B.5.2Functional name of contact pointStudy Project Management
    B.5.3 Address:
    B.5.3.1Street AddressDept of Oncology 9431, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number4535453311
    B.5.5Fax number4535454391
    B.5.6E-mailjoan.loehndorf@regionh.dk
    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.3.1Product namePalbociclib
    D.3.2Product code PD-0332991
    D.3.4Pharmaceutical form Capsule, hard
    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 INNPalbociclib
    D.3.9.1CAS number 571190302
    D.3.9.2Current sponsor codePD-0332991
    D.3.9.3Other descriptive namePD-332,991
    D.3.9.4EV Substance CodeSUB34094
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 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.3.1Product namePalbociclib
    D.3.2Product code PD-0332991
    D.3.4Pharmaceutical form Capsule, hard
    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 INNPalbociclib
    D.3.9.1CAS number 571190302
    D.3.9.2Current sponsor codePD-332,991
    D.3.9.3Other descriptive namePD-332,991
    D.3.9.4EV Substance CodeSUB34094
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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.3.1Product namePalbociclib
    D.3.2Product code PD-0332991
    D.3.4Pharmaceutical form Capsule, hard
    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 INNPalbociclib
    D.3.9.1CAS number 571190-30-2
    D.3.9.2Current sponsor codePD-0332991
    D.3.9.3Other descriptive namePD-332,991
    D.3.9.4EV Substance CodeSUB34094
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 Femara
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    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.3.4Pharmaceutical 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 INNLETROZOLE
    D.3.9.1CAS number 112809-51-5
    D.3.9.4EV Substance CodeSUB08444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Histological confirmed endometrial cancer of endometrioid type. Mixed tumor histology is allowed if the non-endometrioid component is less than 5%. Tumour must be estrogen receptor positive.
    E.1.1.1Medical condition in easily understood language
    Patients with advanced endometrial cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10014741
    E.1.2Term Endometrial cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10014733
    E.1.2Term Endometrial cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10014734
    E.1.2Term Endometrial cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10014735
    E.1.2Term Endometrial cancer NOS
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10014736
    E.1.2Term Endometrial cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10014740
    E.1.2Term Endometrial cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overall objective is to obtain preliminary but not conclusive evidence of efficacy of palbociclib-letrozole combination in comparison to placebo-letrozole combination therapy in the treatment of ER+ advanced or relapsed endometrial cancer.
    The primary objective is therefore to prolong Progression-Free Survival (PFS).
    E.2.2Secondary objectives of the trial
    To prolong PFS in sub-populations.
    To increase objective response rate (ORR).
    To increase disease control rate (DCR).
    To prolong time to first subsequent therapy (TFST).
    To prolong Progression-Free Survival 2 (PFS2).
    To prolong time to second subsequent therapy (TSST).
    To register Patient Reported Outcomes (PROs).
    To register safety and tolerability.
    To register overall survival (OS).
    To evaluate the prognostic and predictive values of tumour biomarkers for Cycline A regarding primary outcome.
    To analyse the correlation of PFS with retinoblastoma protein-expressing tumours.
    Other TR related objectives are to be added.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histological confirmed endometrial cancer of endometrioid type. Mixed tumor histology is allowed if the non-endometrioid component is less than 5%. Tumour must be estrogen receptor positive.
    2. Patients may have received adjuvant chemotherapy for stage 1 or 2.
    3. Patients may have received any lines of chemotherapy for primary advanced (stage 3-4) or relapsed disease.
    4. Patients may have received external beam radiotherapy, brachytherapy, and surgery.
    5. Patient may have received maximum one line of endocrine therapy containing MPA/Megace only.
    Disease Status:
    6. measureable disease or evaluable disease on CT scan according to RECIST 1.1 outside irradiated field.
    7. Patients must give informed consent .
    8. ECOG performance status (PS) of 0-1 (appendix 2).
    9. Serum albumin ≥ 30g/l.
    10. Adequate bone-marrow, renal and hepatic function:
    i. Hepatic function: total bilirubin within normal limits; ALT and AST ≤ 1.5 x ULN in patients without liver metastasis. For patients with liver metastasis: total bilirubin within normal limits, ALT or AST ≤ 2.5 x ULN.
    ii. Coagulation parameters: INR < 2 x ULN; activated partial thromboplastin time (APTT) < 1.5 x ULN in the absence of therapeutic anticoagulation .
    iii. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelets ≥ 100 x 109L; haemoglobin ≥ 9.0 g/dL.
    iv. Proteinuria < grade 2 (IB).
    v. Glomerular Filtration Rate (GFR) ≥40ml/min. (calculated using Cockroft & Gault equation, Jellife equation or measured by EDTA clearance).
    11. Life expectancy of at least 12 weeks.
    12. Patients must be fit to receive combination therapy .
    13. Patient’s age >18 years.
    14. Patient is post-menopausal (Patients under the age of 55 with intact ovaries shall undergo hormonal verification).
    15. Patients with preserved reproductive capacity must have a negative pregnancy test (β-HCG test in urine or serum) prior to commencing study treatment.
    E.4Principal exclusion criteria
    1. Non-endometrioid adenocarcinomas, sarcomas, small cell carcinoma with neuroendocrine differentiation or non-epithelial cancers.
    2. Previous anti-cancer endocrine therapy other than MPA/Megace. This means that eg. tamoxifen is not allowed prior to randomization.
    3. Concurrent cancer therapy (the patient may receive a stable dose of corticosteroids during the course of the study, as long as this was started at least 4 weeks prior to randomization).
    4. Previous treatment with Palbociclib or other CDK inhibitors.
    5. Concurrent treatment with an investigational anticancer agent or participation in another anticancer clinical trial within 21 days prior to randomization.
    6. Treatment within 21 days prior to randomization with any:
    • investigational drugs.
    • radiotherapy (Palliative radiotherapy may be permitted for symptomatic control of pain from bone metastases in extremities, provided that the radiotherapy does not involve target lesions, and the reason for the radiotherapy does not reflect progressive disease).
    • immunotherapy.
    • chemotherapy.
    • hormonal therapy.
    • biological therapy.
    7. Major injuries or surgery within the past 21 days prior to randomization, with incomplete wound healing and/or planned surgery during the on-treatment study period.
    8. Previous malignant disease, except patients with previous malignant disease, for which the patient has been disease-free for at least three years prior to randomization.
    9. Concurrent other malignant disease, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin.
    10. Active infection or other serious underlying medical condition, which might prevent the patient from receiving treatment or to be followed.
    11. Evidence of significant medical illness, abnormal laboratory finding or psychiatric illness/social situation that would, according to the Investigator’s judgment, make the patient inappropriate for this study.
    12. Known hypersensitivity to the trial drugs, or to their excipients.
    13. History of major thromboembolic event defined as:
    • Uncontrolled pulmonary embolism, defined as pulmonary embolism within 6 months prior to enrolment and/or recurrent pulmonary embolism (history of at least 2 events).
    • Deep venous thrombosis, though patients with stable therapeutic anticoagulation for more than three months prior to randomization are eligible for this study.
    • Other related conditions, though patients with stable therapeutic anticoagulation for more than three months prior to randomization are eligible for this study.
    14. History of a cerebral vascular accident, transient ischemic attack or subarachnoid hemorrhage within the past 3 months prior to randomization.
    15. History of clinically significant hemorrhage in the past 3 months prior to randomization.
    16. Uncontrolled and/or symptomatic CNS metastasis or leptomeningeal carcinomatosis (dexamethasone/prednisone therapy will be allowed if administered as stable dose for at least one month prior to randomization).
    17. Significant cardiovascular diseases, including uncontrolled hypertension (hypertension not controlled by medical therapy), uncontrolled clinically relevant cardiac arrhythmia, unstable angina or myocardial infarction within 6 months prior to randomization, congestive heart failure > NYHA III (appendix 8), severe peripheral vascular disease, clinically significant pericardial effusion.
    18. Pregnancy or breastfeeding.
    19. Patients with preserved reproductive capacity, unwilling to use a medically acceptable method of non-hormonal contraception for the duration of the trial and for 3 months after ended treatment.
    20. Known active or chronic hepatitis C and/or B infection and/or HIV infection.
    21. Persistence of clinically relevant grade 3-4 therapy related toxicity from previous chemotherapy and/or radiotherapy.
    22. Gastrointestinal disorders or abnormalities that would interfere with absorption of the study drug.
    23. Unable or unwilling to swallow tablets/capsules
    24. Patients unable to be regularly followed for any reason (geographic, familiar, social, phycologic, housed in an institution eg. prison because of a court agreement or administrative order).
    25. Subjects who are dependent on the sponsor/CRO or investigational site or on the investigator in any way.
    E.5 End points
    E.5.1Primary end point(s)
    PFS: time from date of randomization to date of progression or death.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Analysis will be performed once 68 events are registered
    No interim analysis is planned
    E.5.2Secondary end point(s)
    PFS of patients in sub-populations, as described under stratification factors.
    ORR according to Response Evaluation Criteria in Solid Tumours 1.1 (RECIST) (appendix 5).

    DCR: Complete Response, Partial Response or Stable Disease (CR+PR+SD).
    DCR for at least 12 weeks.

    TFST: time from randomization to first subsequent therapy or death.
    PFS2: time from randomization to second subsequent disease progression or death.
    TSST: time from randomization to second subsequent therapy or death.
    PROs, eg. via QoL scores (appendix 3 and 4).
    Safety and tolerability in the two treatment arms, eg. Via adverse event (AE) registration.
    Compliance in the two treatment arms, eg. via patient diary.
    OS: The percentage of people in each of the two treatment arms, who are still alive 3,5 years after randomization.
    PFS with or without retinoblastoma protein-expressing tumours
    E.5.2.1Timepoint(s) of evaluation of this end point
    Only after the primary end-point is mature
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) No
    E.7.1.1First administration to humans No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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
    End of Trial: 01.September 2026
    After reaching events on Overall
    Survival (OS), we need 6-12 months to complete the Study Report,
    therefore LVLS is not equal to end of trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 78
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ENGOT
    G.4.3.4Network Country European Union
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-29
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