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    Summary
    EudraCT Number:2018-002886-21
    Sponsor's Protocol Code Number:UC-0110/1809
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-10-22
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-002886-21
    A.3Full title of the trial
    A Phase III randomized study evaluating gemcitabine and paclitaxel versus gemcitabine alone after FOLFIRINOX failure or intolerance in Metastatic Pancreatic Ductal Adenocarcinoma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    _
    A.3.2Name or abbreviated title of the trial where available
    GEMPAX
    A.4.1Sponsor's protocol code numberUC-0110/1809
    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 SponsorUNICANCER
    B.1.3.4CountryFrance
    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 supportProgramme hospitalier de recherche clinique (PHRC)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address101 rue de Tolbiac
    B.5.3.2Town/ cityPARIS Cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number33171 93 61 60
    B.5.5Fax number33144 23 55 69
    B.5.6E-mailn-lachaux@unicancer.fr
    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 Yes
    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 Powder for concentrate 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.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38
    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 Yes
    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 Concentrate 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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Ductal Adenocarcinoma
    E.1.1.1Medical condition in easily understood language
    Advanced pancreas cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the superiority in terms Overall Survival (OS) of gemcitabine + solvent-based (sb)-paclitaxel over gemcitabine alone in metastatic pancreatic ductal adenocarcinoma after FOLFIRINOX failure or intolerance.
    E.2.2Secondary objectives of the trial
    The secondary objectives are the evaluation of:
    - The efficacy of the treatments in terms of:
    *Objective Response rate (according to RECIST 1.1) (ORR)
    *Progression-Free Survival (PFS)
    *Disease Control Rate at 4 months (4m-DCR)
    - Prognostic and predictive values of several biomarkers (Ca 19-9, CEA, neutrophil to lymphocyte ratio, albumin, Glasgow prognostic score)
    - Dose intensity of chemotherapy
    - Safety and tolerability of treatment (NCI-CTCAE version 5.0)
    - The effect of treatments on Quality of Life
    - The rate of subsequent chemotherapy (after progression)
    - Potential new biomarkers that may provide relevant information for clinicians as to whether the patients benefit from chemotherapy and to study the biomarkers dynamics across time and their association with primary and secondary endpoints of the trial.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Analysis of constitutional DNA and circulating tumor DNA to observ correlation of tumor molecular biomarkers with clinical outcomes.
    E.3Principal inclusion criteria
    1. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
    2. Age ≥18 years old.
    3. At least one evaluable lesion according to RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) outside any previously irradiated area.
    4. Failure of first line FOLFIRINOX therapy due to progressive disease during or within 3 months after the end of therapy (including mFOLFIRINOX in adjuvant setting) or patient with FOLFIRINOX intolerance
    5. Performance Status (PS) ECOG 0 to 2.
    6. Life expectancy ≥12 weeks.
    7. Negative serology (HIV, hepatitis B and C)
    8. Adequate organs function:
    - Absolute neutrophils count ≥1.5x109/L
    - Platelets count ≥100x109/L
    - Haemoglobin ≥9 g/dl
    - Serum bilirubin levels <2 times upper limit of normal (ULN), up to 2.5 times ULN in case of hepatic metastasis (biliary drainage allowed)
    - Transaminases <5 times ULN.
    9. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.
    10. Woman of childbearing potential and male patients must agree to use adequate contraception for the duration of trial participation and up to 6 months after completing treatment/therapy
    11. Patients affiliated to the social security system
    12. Patient must have signed a written informed consent form prior to any trial specific procedures
    E.4Principal exclusion criteria
    1. Any other primary tumor or secondary malignancy except basal cell carcinoma of the skin or in situ carcinoma of the cervix uteri (patients adequately treated for other malignancies and without tumor during the last 5 years are eligible).
    2. Known cerebral metastasis.
    3. Uncontrolled severe infections.
    4. Patients with Kaposi’s sarcoma
    5. Peripheral neuropathy exceeding CTCAE (Common Terminology Criteria for Adverse Events) v5.0 grade 2.
    6. Previous treatment with taxane.
    7. Patients with known allergy or severe hypersensitivity to any of the trial drugs or any of the trial drug excipients
    8. Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment.
    9. Patients unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial.
    10. Participation in another clinical trial within 14 days prior to randomization.
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS), defined as the time from date of randomization to the date of death from any cause. If a patient is alive at the database cut-off date, then the patient will be censored at the last date of follow-up
    E.5.1.1Timepoint(s) of evaluation of this end point
    _
    E.5.2Secondary end point(s)
    - Efficacy objective:
    *ORR (according to RECIST 1.1 criteria) defined as the percentage of patients with Complete Response (CR) or Partial Response (PR). Patients who discontinue treatment without a tumour assessment will be considered non-responders for the analysis
    *PFS defined as the time from the date of randomisation to date of disease progression (radiological or clinical) or death from any cause, whichever occurs first. Patients without tumour progression or death at the time of analysis will be censored at the date of their last tumour assessment.
    *4m-DCR is defined as proportion of patients with CR, PR, or a stable disease (SD), 4 months after treatment initiation.
    - Value of biomarkers (Ca 19-9, CEA, Lymphocyte to Neutrophil ratio, albumin, Glasgow prognostic score) will be described by absolute or relative variation from baseline. To assess their prognostic or predictive values, baseline values of these biomarkers will be tested using Cox or logistic regression models.
    - Dose intensity of chemotherapy will be calculated from doses actually given instead of from targeted doses. Ratio between dose received compared to theoretical ones will be calculated by patient and presented as a percentage.
    - Safety and tolerability of treatment (NCI-CTCAE version 5.0) determined through the incidence of adverse events, treatment related adverse events, serious adverse Events (SAE), and death.
    - Quality of life (EORTC QLQ-C30) during treatment. A deterioration of scores for five-targeted dimensions: pain, physical and emotional functioning, fatigue, and appetite will be compared between the two treatment arms, while other dimensions will be regarded as exploratory. 5 point deterioration in HRQoL scores will be considered as the minimal clinically important difference (MCID).
    - Rate of subsequent chemotherapy (after progression). The type and the date of beginning of first-cycle of each line will be collected.
    - Translational research to identify biomarkers predictive of response in this clinical context
    E.5.2.1Timepoint(s) of evaluation of this end point
    _
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    Biomarkers study
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    gemcitabine + paclitaxel vs gemcitabine alone
    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 concerned24
    E.8.5The trial involves multiple Member States No
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 150
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 60
    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 state210
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-05-11
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