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    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-004611-13
    Sponsor's Protocol Code Number:G1T28-03
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-02-16
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-004611-13
    A.3Full title of the trial
    Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer (SCLC) Receiving Topotecan Chemotherapy
    Fase 1b/2a studie naar de veiligheid en farmacokinetiek van G1T28 bij patiënten met eerder behandelde kleincellige longkanker (SCLC) in het uitgebreide stadium, die chemotherapie met topotecan krijgen
    Étude de phase 1b/2a évaluant la sécurité d’emploi et la pharmacocinétique du G1T28 chez les patients atteints d’un cancer du poumon à petites cellules (CPPC) de stade étendu traité antérieurement et qui reçoivent une chimiothérapie à base de topotécan
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to test the safety and plasma concentration of G1T28 in combination with topotecan in patients with previously treated extensive stage small cell lung cancer
    A.4.1Sponsor's protocol code numberG1T28-03
    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 SponsorG1 Therapeutics
    B.1.3.4CountryUnited States
    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 supportG1 Therapeutics, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationG1 Therapeutics, Inc
    B.5.2Functional name of contact pointClinical Trial Info
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 110341
    B.5.3.2Town/ cityResearch Triangle Park
    B.5.3.3Post codeNC 27709
    B.5.3.4CountryUnited States
    B.5.4Telephone number+19192139835
    B.5.5Fax number+19197415830
    B.5.6E-mailclinicalinfo@g1therapeutics.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.3.1Product nameTrilaciclib
    D.3.2Product code G1T28
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNG1T28 Di-HCl
    D.3.9.2Current sponsor codeG1T28
    D.3.9.3Other descriptive nameG1T28
    D.3.9.4EV Substance CodeSUB181989
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Extensive-Stage Small Cell Lung Cancer
    E.1.1.1Medical condition in easily understood language
    Cancer of small lung cells
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10041068
    E.1.2Term Small cell lung cancer extensive stage
    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
    1. Assess the dose -limiting toxicities (DLTs) and define the Phase 2 dose of G1T28 administered with topotecan (please note this is related only to Part 1 - Phase 1b study; we will be conducting only Parts 2A and 2B- Phase 2a study)
    2. Assess the safety and tolerability of G1T28 administered with topotecan
    E.2.2Secondary objectives of the trial
    1. Assess the pharmacokinetic (PK) profile of G1T28
    2. Assess the PK profile of topotecan when administered with G1T28
    3. Assess the hematologic profile (kinetics and incidence/duration/frequency of toxicities) of G1T28 administered with topotecan
    4. Assess the incidence of febrile neutropenia
    5. Assess the incidence of infections
    6. Assess the utilization of red blood cells (RBC) and platelet transfusions
    7. Assess the utilization of hematopoietic growth factors
    8. Assess the utilization of systemic antibiotics
    9. Assess the incidence of chemotherapy dose reductions and dose interruptions overall
    10. Assess the incidence of Grade 2 or greater nephrotoxicity
    11. Assess tumor response based on RECIST, Version 1.1
    12. Assess progression free survival (PFS) and overall survival
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry
    3. Progression during or after prior first- or second-line chemotherapy and eligible to receive topotecan therapy (immunotherapy treatment alone, ie, not administered with chemotherapy, should not be counted as a line of chemotherapy)
    4. At least 1 target lesion that is measurable by RECIST, Version 1.1
    5. Absolute neutrophil count ≥ 1.5 × 109/L
    6. Platelet count ≥ 100 × 109/L
    7. Creatinine ≤ 1.5 mg/dL and creatinine clearance (CrCl) of ≥ 60 mL/minute)
    8. Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
    9. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; ≤ 5 × ULN in the
    presence of liver metastases
    10. Serum albumin ≥ 3 g/dL
    11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
    12. All clinically significant toxicities from previous anticancer therapy must have resolved to ≤ Grade 1 (except for hemoglobin)
    13. Contraception:
    a. For females: All females of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test result at screening and negative serum or urine β-hCG test result at baseline.
    Females must be either postmenopausal, surgically sterile, or using an acceptable method of contraception in combination with a barrier method.
    Acceptable surgical sterilization techniques are hysterectomy, bilateral tubal ligation with surgery at least 6 months prior to dosing, and bilateral oophorectomy, with surgery at least 2 months prior to dosing. Acceptable methods of contraception to be used in combination with a barrier method are an intrauterine device, contraceptive implant, oral contraceptive (stable dose of the same hormonal contraceptive product for at least 3 months prior to dosing), or a vasectomized partner. These methods are to be utilized during the study and for 3 months after discontinuation of treatment
    b. For males: Patients with female partner of childbearing potential must agree to use a highly effective form of birth control, which entails the use of oral, injected, or implanted hormonal methods of contraception or an intrauterine device/system by the female partner, in combination with a barrier method (eg, condom, diaphragm, cervical cap) during the study and for 3 months after discontinuation of treatment, and will also refrain from sperm donation for 3 months following completion of the study
    14. Able to understand and sign an informed consent
    E.4Principal exclusion criteria
    1. History of topotecan treatment for SCLC
    2. Presence of brain metastases requiring immediate treatment with radiation therapy or steroids
    3. History of other malignancies, except for the following:
    (1) adequately treated basal or squamous cell carcinoma of the skin;
    (2) curatively treated a) in situ carcinoma of the uterine cervix, b) prostate cancer, or c) superficial bladder cancer; or
    (3) other curatively treated solid tumor with no evidence of disease for ≥ 3 years
    4. Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure (Class III or IV as defined by the New York Heart Association [NYHA] functional classification system)
    5. Known history of stroke or cerebrovascular accident within 6 months prior to enrollment
    6. Serious active infection
    7. Psychiatric illness/social situations that would limit study compliance
    8. Other uncontrolled serious chronic disease or conditions that in the investigator’s opinion could affect compliance or follow-up in the protocol
    9. History of upper gastrointestinal bleeding, ulceration, perforation, or significant gastrointestinal disease within 12 months prior to study enrollment
    10. Known human immunodeficiency virus (HIV) positive; known hepatitis B virus (HBV) positive; or known hepatitis C virus (HCV) positive that is symptomatic or requiring active therapy
    11. Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment or previous radiotherapy to the target lesion sites (the sites that are to be followed for
    determination of a response)
    12. Receipt of any systemic chemotherapy regimen within 4 weeks prior to enrollment or a noncytotoxic investigational medication within 2 weeks prior to enrollment
    13. Receipt of any low-dose systemic chemotherapeutic agent given for a nononcologic purpose within 4 weeks prior to enrollment (eg, low-dose methotrexate for rheumatoid arthritis)
    14. Hypersensitivity to any of the components of the formulation of topotecan
    15. Legal incapacity or limited legal capacity
    16. Pregnant or lactating women
    E.5 End points
    E.5.1Primary end point(s)
    To assess the safety and tolerability of combining G1T28 with topotecan and to evaluate the effect of G1T28) on chemotherapy induced myelosuppression.

    (NOTE: relevant for Parts 2A and 2B - Phase 2a study)
    E.5.1.1Timepoint(s) of evaluation of this end point
    As defined per protocol.
    E.5.2Secondary end point(s)
    • To assess the pharmacokinetic (PK) profile of G1T28
    • To assess the hematologic profile (kinetics and incidence/duration/frequency of toxicities) of G1T28 administered with topotecan
    • To assess the incidence of febrile neutropenia
    • To assess the incidence of infections
    • To assess the utilization of Red Blood Cells (RBC) and platelet transfusions
    • To assess the utilization of hematopoietic growth factors
    • To assess the utilization of systemic antibiotics
    • To assess the incidence of chemotherapy dose reductions and dose interruptions overall
    • To assess the incidence of Grade 2 or greater nephrotoxicity
    • To assess tumor response based on RECIST,Version 1.1
    • To assess progession-free survival (PFS) and overall survival

    (NOTE: relevant for Parts 2A and 2B - Phase 2a study)
    E.5.2.1Timepoint(s) of evaluation of this end point
    As defined per protocol.
    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 No
    E.6.6Pharmacokinetic Yes
    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 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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Bosnia and Herzegovina
    Macedonia, the former Yugoslav Republic of
    Serbia
    United States
    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
    Patients will be followed for survival via monthly phone calls at a minimum until 50% of the patients in Parts 2A and 2B of the study have died.
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 90
    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)
    For those patients in the survival follow-up who have not progressed at the time of study drug discontinuation, tumor assessments, including all sites of disease, will be assessed radiologically by CT or MRI every 2 months (approximately 60 ± 7 days) until the occurrence of progressive disease or study completion.
    Patients will continue to receive standard of care treatment as per institutional guidelines.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-10-04
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