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    Summary
    EudraCT Number:2011-003753-26
    Sponsor's Protocol Code Number:GS-US-324-0101
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-12-19
    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 ConcernedGermany - PEI
    A.2EudraCT number2011-003753-26
    A.3Full title of the trial
    A Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined with gemcitabine as First Line Treatment for Metastatic Pancreatic Adenocarcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to test the effectiveness and safety of GS-6624 at different dose levels when it is given with Gemcitabine. We want to find out what effects, good and/or bad, GS-6624 has on you and your metastatic pancreatic adenocarcinoma when it is given with Gemcitabine. Gemcitabine is approved by the FDA for metastatic pancreatic adenocarcinoma.
    A.4.1Sponsor's protocol code numberGS-US-324-0101
    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 SponsorGilead Sciences, Inc.
    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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences, Inc.
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address333 Lakeside Drive
    B.5.3.2Town/ cityFoster City
    B.5.3.3Post codeCA 94404
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650522 4707
    B.5.5Fax number+1866454 1397
    B.5.6E-mailZung.Thai@gilead.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 GS-6624
    D.3.4Pharmaceutical form 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.3.9.1CAS number 1318075-13-6
    D.3.9.2Current sponsor codeGS-6624
    D.3.9.3Other descriptive nameGS-6624
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Metastatic Pancreatic Adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Metastatic Pancreatic Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10033599
    E.1.2Term Pancreatic adenocarcinoma metastatic
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the additive efficacy of GS-6624 vs. placebo in combination
    with gemcitabine as measured by improvement in progression free
    survival (PFS)
    E.2.2Secondary objectives of the trial
    To compare the additive efficacy of GS-6624 vs. placebo in combination
    with gemcitabine as measured by
    • Overall Survival (OS)
    • Objective response rate (by modified RECIST version 1.1)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willingness to sign the subject informed consent
    2. Initial diagnosis of metastatic pancreatic cancer must have occurred ≤ 6 weeks
    prior to the completion of screening
    3. The presence of measurable metastatic pancreatic cancer documented
    by contrast enhanced CT (or MRI) scan in addition to 1 of the
    following:
    a) Histological diagnosis of pancreatic adenocarcinoma confirmed by
    pathologist OR
    b) Pathologist confirmed histological/cytological diagnosis of
    adenocarcinoma consistent with pancreatic origin in conjunction with
    either:
    (1) The presence of a mass in the pancreas OR
    (2) A history of resected pancreatic carcinoma
    4. Measurable disease per RECIST (ver. 1.1), defined with all of
    following criteria:
    a) Lesions accurately measured in at least 1 dimension
    b) The longest diameter in the plane of measurement is to be recorded
    c) A minimum size of 10 mm if CT slice thickness ≤ 5 mm; if
    thickness is > 5 mm then the minimum size of measurable lesions
    should be twice slice thickness
    5. Male or female ≥18 years of age
    6. ECOG Performance Status of 0 or 1
    7. Women of childbearing potential must agree to use 1 medically
    approved (i.e., mechanical or pharmacological) contraceptive measure
    and have their partners agree to an additional barrier method of
    contraception for the duration of the study and for 90 days after the last
    administration of study drug
    8. Male subjects must agree to use protocol-recommended methods of
    contraception during heterosexual intercourse and avoid sperm donation
    for the duration of this study and for 6 months after the last dose of
    gemcitabine.
    9. Adequate organ function defined as follows:
    a. Hematological: Platelets ≥100 x 109/L; Hemoglobin ≥9.0 g/dL;
    Absolute Neutrophil
    Count (ANC) ≥1.5 x 109/L
    b. Hepatic: AST/ALT ≤2.5 x ULN (if liver metastases are present, ≤5 x
    ULN); Total or conjugated bilirubin ≤1.5 x ULN
    c. Renal: Serum Creatinine ≤1.5 x ULN OR creatinine clearance ≥ 60
    ml/minute as calculated by the Cockroft-Gault method
    10. Coagulation: International Normalized Ratio (INR) ≤ 1.6 (unless
    receiving anticoagulation therapy). Patients on full-dose anticoagulation
    must be on a stable dose (minimum duration 14 days) of oral
    anticoagulant or low molecular weight heparin. If receiving warfarin, the
    patient must have an INR ≤ 3.0 and no active bleeding (ie, no bleeding
    within 14 days prior to first dose of study therapy).
    E.4Principal exclusion criteria
    1. A history or evidence of clinically significant disorder other than metastatic cancer of the pancreas or clinical significant laboratory finding that in the investigator’s judgment would pose a risk to subject
    safety, interfere with study procedures, or prevent completion of the study
    2. A diagnosis of pancreatic islet neoplasms
    3. Subject has undergone major surgery other than diagnosis surgery within 4 weeks of enrollment (Part A)/ randomization (Part B)
    4. Subjects for whom combination treatment with erlotinib and gemcitabine was planned
    5. Subjects with biliary obstruction requiring external drainage
    6. Pregnant or lactating
    7. Known or suspected cerebral metastases
    8. History or presence of any form of cancer, other than pancreatic
    cancer, within the 3 years prior to enrollment, with the exception of
    excised basal cell or squamous cell carcinoma of the skin, stage 0 or 1
    melanoma, or cervical carcinoma in situ or breast carcinoma in situ that
    has been excised or resected completely and is without evidence of local
    recurrence or metastasis.
    9. Unstable cardiovascular function including but not limited to: myocardial infarction within the last 6 months of screening, symptomatic congestive heart failure (New York Heart Association Classification > Class II), unstable angina, or unstable cardiac arrhythmia requiring medication
    10. Uncontrolled hypertension (seated systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) at Screening.
    11. Clinically active liver disease, including active viral hepatitis (HBV or HCV) or cirrhosis
    12. Known HIV infection
    13. Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ngoing signs/symptoms related to the infection and without improvement) despite appropriate
    antibiotics use
    14. Prior or concurrent anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, retinoid therapy, hormonal therapy) for the treatment of inoperable locally advanced or metastatic pancreatic cancer; prior radiotherapy and chemotherapy given as pre-operative neoadjuvant therapy or radio sensitizers for locally advanced pancreatic cancer are allowed
    15. Participation in an investigational drug or device trial with therapeutic intent within 30 days prior to study Day 1 of Cycle 1 or within 5 times the half-life of the investigational drug in the other clinical
    study, if known, whichever is shorter
    16. Known hypersensitivity to the study investigational medicinal products or formulation excipients
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival
    E.5.1.1Timepoint(s) of evaluation of this end point
    Progression free survival is the primary endpoint is measured as time from
    date of randomization to the earliest event time of a) death regardless of cause, or b) first
    indication of disease progression.
    E.5.2Secondary end point(s)
    Overall Survival
    Objective response rate (by modified RECIST version 1.1)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival is measured as time from date of randomization to death regardless of cause.
    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 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 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 EEA30
    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
    Germany
    Poland
    Russian Federation
    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
    Last patient, last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months20
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months20
    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: 234
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 244
    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)
    After termination from our trials (both) subjects will receive appropriate standard of care provided at the respective institutions.
    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 Decision2012-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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