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    Summary
    EudraCT Number:2009-018240-23
    Sponsor's Protocol Code Number:CO-101-001
    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:2010-02-22
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-018240-23
    A.3Full title of the trial
    A phase II Randomized, Open-Label, Multicenter Study Comparing CO-1.01 With Gemcitabine as First-Line Therapy in Patients with Metastatic Pancreatic Adenocarcinoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine the safety and efficacy of study drug CO-1.01 compared to the current treatment of gemcitabine in patients with cancer of the pancreas
    A.3.2Name or abbreviated title of the trial where available
    LEAP
    A.4.1Sponsor's protocol code numberCO-101-001
    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 SponsorClovis Oncology 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 supportClovis Oncology, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClovis Oncology UK Ltd
    B.5.2Functional name of contact pointDr. Lindsey Rolfe
    B.5.3 Address:
    B.5.3.1Street AddressSheraton House, Castle Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB3 0AX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number441223370037
    B.5.6E-maillrolfe@clovisoncology.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/680
    D.3 Description of the IMP
    D.3.1Product nameCO-1.01
    D.3.2Product code CO-1.01
    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.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 210829-30-4
    D.3.9.2Current sponsor codeCO-1.00
    D.3.9.3Other descriptive namegemcitabine-5'-elaidate acid ester
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Gemedac
    D.2.1.1.2Name of the Marketing Authorisation holderMedac
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameGemedac
    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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 pancreatic cancer
    E.1.1.1Medical condition in easily understood language
    Pancreatic cancer that has spread to other areas of the body
    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 10033605
    E.1.2Term Pancreatic cancer metastatic
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of CO-1.01 and gemcitabine in patients with metastatic pancreatic adenocarcinoma and low human equilibrative nucleoside transporter 1 (hENT1) expression
    E.2.2Secondary objectives of the trial
    • To compare the efficacy of CO-1.01 and gemcitabine in patients with metastatic pancreatic adenocarcinoma and known hENT1 status (all patients and high hENT1 expression).
    • To compare the tolerability and toxicity of CO-1.01 with gemcitabine.
    • To compare changes in pain severity in patients receiving CO-1.01 and gemcitabine.
    • To compare changes in health status in patients receiving CO-1.01 and gemcitabine.
    • To perform sparse PK sampling in patients taking CO-1.01 to contribute towards development of a population PK model of CO-1.01.
    • To evaluate the clinical utility of the hENT1 diagnostic test.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible for the study if all of the following criteria are met:
    • Metastatic pancreatic ductal adenocarcinoma (i.e., Stage 4).
    • Histological/cytological confirmation of metastatic tissue (not primary tumor) by a central pathology laboratory (H&E stain) to ensure sufficient material is available for later hENT1 analysis.
    − Biopsy from metastases must be obtained ≥3 months after adjuvant chemotherapy (if applicable).
    − Paraffin block or freshly fixed tissue sufficient for preparing ≥6 unstained slides for central storage and subsequent hENT1 analysis is required.
    • Adjuvant chemotherapy/radiotherapy (if administered) ≥6 months prior to randomization.
    • Palliative radiotherapy (if administered) ≥1 month prior to randomization.
    • CT scan ≤30 days prior to randomization.
    • Performance Status (ECOG) 0 or 1.
    • Estimated life expectancy ≥12 weeks.
    • Age ≥18 years.
    • Adequate hematological and biological function, which is defined as the following:
    Bone marrow function
    − Neutrophils ≥1.5 × 10 to the power of 9/L
    − Platelets >100.0 × 10 to the power of 9/L
    − Hemoglobin ≥9 g/dL
    Hepatic function
    − AST ≤2.5 × upper limit of normal (ULN); if liver metastases, ≤5 × ULN
    − Bilirubin ≤1.5 times ULN; if liver metastases, ≤3 × ULN
    − Albumin >3 g/dL
    − PT/PTT within 10% ULN
    Renal function
    − Serum creatinine ≤1.5 × ULN
    • Written consent on an IRB/IEC-approved Informed Consent Form prior to any study-specific evaluation.
    E.4Principal exclusion criteria
    Patients are excluded from the study if any of the following criteria are met:
    • Prior palliative chemotherapy for pancreatic cancer.
    • Radical pancreatic resections (e.g., Whipple procedure) are not allowed < 6 months prior to randomization. Exploratory laparotomy, palliative (e.g., bypass) surgery, or other procedures (e.g., stents) are not allowed <14 days prior to randomization. In both cases the patient must be sufficiently recovered and stable.
    • Symptomatic brain metastases.
    • Participation in other investigational drug clinical studies ≤30 days prior to randomization.
    • Concomitant treatment with prohibited medications (e.g., concurrent anticancer therapy including other chemotherapy, radiation, hormonal treatment, or immunotherapy) ≤30 days prior to randomization.
    • History of allergy to gemcitabine or eggs.
    • Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled intercurrent illness including active infection, arterial thrombosis, symptomatic pulmonary embolism).
    • Any disorder that would hamper protocol compliance.
    • Prior nonpancreatic malignancy treated with chemotherapy. Prior malignancies treated with surgery or radiotherapy alone must be in remission ≥3 years. Prior malignancies allowed irrespective of when they occurred are in situ carcinoma of the cervix, in situ ductal breast cancer, low-grade local bladder cancer, and nonmelanotic
    skin cancer.
    • Females who are pregnant or breastfeeding.
    • Refusal to use adequate contraception for fertile patients (females and males during the study and for 6 months after the last protocol-specified treatment). Adequate forms of contraception are docuble-barrier methods (condoms or diaphragm with spermicidal jelly or foam); oral, depot, or injectible contraceptives, interuterine devices; tubal ligation.
    • Any other reason the investigator considers the patient should not participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The overall survival (OS) in patients with low hENT1 expression
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint analysis will take place when 90 events of death
    have been observed in the hENT1-low patients.
    E.5.2Secondary end point(s)
    • OS in all patients and patients with high hENT1 expression
    • Objective tumor response rate (ORR), duration of response, and progression free survival (PFS) in patients with measurable/evaluable disease, using RECIST 1.1.
    • CA 19-9 velocity and response rate.
    • Drug tolerability and toxicity using clinical AE monitoring, clinical laboratory testing, ECG outcomes, and dose modifications of protocol-specified treatment
    • Change from baseline in pain severity measured by the worst pain on the Brief Pain Inventory (BPI) short form.
    • Change from baseline in health status measured by the European Quality of Life-5 Dimension (EQ-5D) instrument and European Quality Visual Analog Scale (EQ VAS)
    • PK profile of CO-1.01 based on sparse sampling.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary analyses will occur when 90 events of death have been
    observed in the hENT1-low patients. AEs will be assessed from the time informed consent (IC) is obtained through 28 days after the last
    protocol-specified treatment administration.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned3
    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 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
    Argentina
    Australia
    Brazil
    Canada
    Russian Federation
    Ukraine
    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
    The study will close once all CO-1.01 patients have either completed participation or have transferred to a locally approved treatment access program in accordance with relevant local regulations.
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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.1.1Number 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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 41
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 142
    F.4.2.2In the whole clinical trial 360
    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 stopping protocol-specified treatment, all patients will remain in the study and will be followed for safety (up to 28 days after last dose), for disease progression (every 8 ± 1 weeks) until disease progression, and for survival status (at approximately monthly intervals until death).
    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 Decision2010-03-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-21
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