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    Summary
    EudraCT Number:2016-001583-11
    Sponsor's Protocol Code Number:G1T28-02
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-11-23
    Trial results View 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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-001583-11
    A.3Full title of the trial
    Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients with Extensive-Stage Small Cell Lung Cancer (SCLC) Receiving Etoposide and Carboplatin Chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the safety and tolerability of combining G1T28 with etoposide and carboplatin therapy and to evaluate the effect of G1T28 on blood cell production affected by chemotherapy.
    A.3.2Name or abbreviated title of the trial where available
    G1T28 safety and pharmacokinetic study in patients receiving etoposide and carboplatin
    A.4.1Sponsor's protocol code numberG1T28-02
    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
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationG1 Therapeutics
    B.5.2Functional name of contact pointClinical Information Contact
    B.5.3 Address:
    B.5.3.1Street AddressPO Box 110341
    B.5.3.2Town/ cityReserach Triangle Park
    B.5.3.3Post codeNC 27709
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019192139835
    B.5.5Fax number0019197415830
    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 nameG1T28 Di-HCl
    D.3.2Product code G1T28
    D.3.4Pharmaceutical form Powder for solution for 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
    D.3.9.2Current sponsor codeG1T28
    D.3.9.3Other descriptive nameG1T28 Di-HCl
    D.3.9.4EV Substance CodeSUB181938
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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
    D.8 Placebo: 2
    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 (SCLC)
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    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
    Assess the DLTs and define the Phase 2 dose of G1T28 administered with E/P therapy.
    Assess the safety and tolerability of G1T28 administered with E/P therapy.
    E.2.2Secondary objectives of the trial
    Assess the PK profile of G1T28, Assess the PK profile of etoposide and carboplatin when administered with G1T28, Assess the hematologic profile (kinetics and incidence/duration/frequency of toxicities) of G1T28 administered with E/P therapy, Assess the incidence of febrile neutropenia, Assess the incidence of infections, Assess the utilization of RBC and platelet transfusions, Assess the utilization of hematopoietic growth factors, Assess the utilization of systemic antibiotics, Assess the incidence of chemotherapy dose reductions and dose interruptions overall, Assess the incidence of Grade 2 or greater nephrotoxicity, Assess tumor response based on RECIST, Version 1.1, Assess 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. Extensive-stage disease
    4. At least 1 target lesion that is unirradiated and measurable by RECIST, Version 1.1 (Eisenhauer 2009)
    5. Hemoglobin ≥ 9.0 g/dL
    6. Absolute neutrophil count ≥ 1.5 × 109/L
    7. Platelet count ≥ 100 × 109/L
    8. Creatinine ≤ 1.5 mg/dL OR glomerular filtration rate (GFR) of ≥ 60 mL/min (by Cockcroft-Gault formula [Cockcroft and Gault 1976]); creatinine clearance calculated from an isotopic method or a 24-hour urine collection may be used instead of an estimated GFR by the Cockcroft-Gault formula
    9. Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
    10. AST and ALT ≤ 2.5 × ULN; ≤ 5 × ULN in the presence of liver metastases
    11. Serum albumin ≥ 3 g/dL
    12. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
    13. Predicted life expectancy of ≥ 3 months
    14. 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 at baseline. Females must be either postmenopausal, surgically sterile, or using an acceptable method of contraception. 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 are an intrauterine device, contraceptive implant, oral contraceptive (stable dose of the same hormonal contraceptive product for at least 3 months prior to dosing), a vasectomized partner, and a barrier method (condom or diaphragm) 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
    15. Able to understand and sign an informed consent.
    E.4Principal exclusion criteria
    1. Prior chemotherapy for limited or extensive-stage SCLC
    2. Presence of symptomatic 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. Known human immunodeficiency virus (HIV), known hepatitis B virus (HBV), or known hepatitis C virus (HCV) positive that is symptomatic or requiring active therapy
    10. 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)
    11. Receipt of any investigational medication within 4 weeks prior to enrollment
    12. Hypersensitivity to any of the components of the formulation of etoposide or etoposide phosphate
    13. Hypersensitivity to cisplatin or other platinum-containing compounds, or mannitol
    14. Legal incapacity or limited legal capacity
    15. Pregnant or lactating women


    E.5 End points
    E.5.1Primary end point(s)
    Efficacy evaluation will be based on the following endpoints: hematologic kinetics, hematologic toxicities, chemotherapy exposure and compliance, other efficacy endpoints and exploratory efficacy.
    Safety will be assessed by evaluation of AEs, infusion-related reactions, vital signs, physical examination, ECG readings, clinical hematology, chemistry and urinalysis results, concomitant medications, tumour response and best overall response based on RECIST, Version 1.1, progression-free survival and overall survival.
    Exploratory analyses examining the relationship between hematologic toxicity rates and hematologic changes with study drug exposure will be performed based on rate of chemotherapy interruptions and rate of chemotherapy reductions.
    Exploratory analyses will be performed to assess the impact of hematologic kinetics on overall survival, PFS, and best overall response rate. Similarly, exploratory analyses will be performed to assess the impact of cumulative chemotherapy exposure on overall survival, PFS, and best overall response rate. Exploratory analyses will be described in the SAP.
    The relationship between G1T28 plasma concentration and hematologic parameter values will be assessed with the Pearson product-moment correlation statistics.
    During Part 1 of the study, serial blood samples will be collected on Days 1 and 3 of Cycle 1 to determine G1T28, etoposide, and carboplatin plasma concentrations.
    To evaluate the impact of G1T28 administration on chemotherapy-induced changes of the immune system, peripheral blood immune subsets will be characterized in patients enrolled into Part 2 of the study. The immunophenotypic change from baseline will be listed and summarized by treatment arm, if data warrant.
    Additional exploratory analyses on the relationship between the immunophenotypic changes and safety and efficacy findings may be performed.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As defined in the protocol
    E.5.2Secondary end point(s)
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose-finding study to assess the safety, dose-limiting toxicities and pharmacokinetics of G1T28
    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 No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    Part 1 of the study is open label. Part 2 is a randomised, double-blind, placebo-controlled design
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Czech Republic
    France
    Georgia
    Hungary
    Moldova, Republic of
    Poland
    Romania
    Spain
    United Kingdom
    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
    Survival follow up will continue until a minimum of 50% patients in Part 2 have died. Final analysis will be completed when last patient completed Post Treatment Visit (PTV). If survival follow up continues past last patient PTV then end of study analysis will be completed as a supplementary analysis.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with an incurable disease.
    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 40
    F.4.2.2In the whole clinical trial 110
    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 return to the study center for a Post-Treatment Visit within 30 days from the last
    dose (+ 3 days) - details specified in the protocol section 10.6-10.7.
    Patients will also continue to have CT/MRI every 2 months until disease progression. Monthly follow up survival calls and Part 2 patients have a clinic visit 60 days post treatment.
    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 Decision2017-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-22
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