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    Summary
    EudraCT Number:2010-020325-40
    Sponsor's Protocol Code Number:PM2734-B-002-09
    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:2010-07-06
    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 number2010-020325-40
    A.3Full title of the trial
    Phase Ib/II, Multicenter, Open-Label, Randomized, Clinical Study with Dose
    Optimization of Two Different Schedules of Elisidepsin Trifluoroacetate
    (Irvalec®) as a Single Agent in Patients with Unresectable, Locally Advanced or
    Metastatic Esophageal, Esophagogastric Junction or Gastric Cancer After
    Failure of One but not More than Two Prior Lines of Systemic Therapy
    A.3.2Name or abbreviated title of the trial where available
    IMAGE
    A.4.1Sponsor's protocol code numberPM2734-B-002-09
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPharma Mar, S.A. Sociedad Unipersonal
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameIRVALEC (elisidepsin trifluoroacetate)
    D.3.2Product code PM02734
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNelisidepsin trifluoroacetate
    D.3.9.1CAS number 915713-02-09
    D.3.9.2Current sponsor codePM02734
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Locally Advanced or Metastatic Esophageal, Esophagogastric Junction or Gastric Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10056267
    E.1.2Term Gastroesophageal cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase Ib stage:
    - To determine the optimal dose of elisidepsin as a single agent administered as a 24-hour intravenous (i.v.) infusion fortnightly or as a 3-hour i.v. infusion weekly to patients with unresectable, locally advanced or metastatic esophageal, esophagogastric junction or gastric cancer who failed one but not more than two prior lines of systemic anticancer therapy. In both study regimens, each cycle will last four weeks.
    Phase II stage:
    - To determine the antitumor activity of elisidepsin as a single agent administered as a 24-hour i.v. infusion fortnightly or as a 3-hour i.v. infusion weekly in the study
    patient population.
    E.2.2Secondary objectives of the trial
    Phase Ib stage:
    - To determine the antitumor activity of elisidepsin as a single agent administered as a 24-hour i.v. infusion fortnightly or as a 3-hour i.v. infusion weekly.
    Both stages:
    - To characterize the safety profile and feasibility of elisidepsin in patients with unresectable, locally advanced or metastatic esophageal, esophagogastric junction or gastric cancer.
    - To determine the time-to-event outcomes and response rate.
    - To characterize the pharmacokinetics (PK) and pharmacodynamics (PDy) of elisidepsin when administered as a single agent in patients with esophageal,
    esophagogastric junction or gastric cancer.
    - To perform a preliminary pharmacogenomic (PGx) study to explore potential biological markers of tumor sensitivity/resistance to elisidepsin in patients with
    esophagogastric cancer.
    Each of these secondary endpoints will be characterized separately for each study regimen.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Previously available tumor samples from patients treated with elisidepsin will be used to analyze the expression of putative markers of response/resistance to elisidepsin. Available tumor samples from any previous biopsies and/or surgical procedures (paraffin-embedded tissue and/or fresh frozen tissue) will be collected. Participation in the PGx substudy will not subject the patients to any additional procedures. The markers to be analyzed will be selected based on the existing knowledge at the time of analysis, resulting from previous PGx and mechanism of action (MoA) studies.
    E.3Principal inclusion criteria
    1. Age ≥ 18 years.
    2. Eastern Cooperative Oncology Group (ECOG) PS of ≤ 1 (see Appendix 1).
    3. Life expectancy ≥ 3 months.
    4. Patients with histologically/cytologically confirmed diagnosis of locally advanced
    (unresectable) or metastatic esophageal, esophagogastric junction or gastric cancer.
    Patients must have received one but not more than two prior lines of systemic
    therapy and must be progressing after last prior therapy before study entry.
    5. Adequate bone marrow, renal, hepatic, and metabolic function (assessed ≤ 7 days
    before first study drug administration):
    a) Platelet count ≥ 100 x 109/l, hemoglobin ≥ 8.5 g/dl and absolute neutrophil count (ANC) ≥ 1.0 x 109/l.
    b) Aspartate aminotransferase (AST) and ALT ≤ 3.0 x upper limit of normal (ULN), independently of the presence of liver metastases.
    c) Direct bilirubin ≤ ULN and total bilirubin ≤ 1.5 x ULN.
    d) International Normalized Ratio (INR) ≤ 1.5 (except if ongoing oral anticoagulation therapy).
    e) Renal function: patients with calculated creatinine clearance (using Cockcroft
    and Gault’s formula, see Appendix 3) ≥ 30 ml/min.
    f) Albumin ≥ 2.5 g/dl.
    6. Recovery to grade ≤ 1 from any AE derived from any previous anticancer treatment
    (excluding alopecia and grade 2 non-painful peripheral neuropathy).
    7. Women of childbearing potential must have a negative serum pregnancy test before study entry. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for six months after
    discontinuation of treatment. Acceptable methods of contraception include
    complete abstinence, intrauterine device (IUD), oral contraceptive, subdermal
    implant and double barrier (condom with a contraceptive sponge or contraceptive
    suppository).
    8. Voluntarily signed and dated written informed consent, obtained from the patient
    prior to any specific study procedure.
    E.4Principal exclusion criteria
    1. Concomitant diseases/conditions:
    a) Clinically relevant non-neoplastic liver disease [i.e., cirrhosis; active chronic
    hepatitis, hepatitis C virus (HCV)/hepatitis B virus (HBV) infection].
    b) History or presence of unstable angina, myocardial infarction, clinically relevant valvular heart disease, treatment-requiring and/or symptomatic arrhythmia or congestive heart failure within the last six months prior to enrollment.
    c) Active uncontrolled infection.
    d) Known human immunodeficiency virus infection (HIV1/2).
    e) Limitation of the patient’s ability to comply with the treatment or follow-up protocol.
    f) Parenteral nutritional support ≥ 25% of total daily caloric requirements.
    g) Any other major illness that, in the Investigator’s or the Sponsor’s judgment, will substantially increase the risk associated with the patient’s participation in this study.
    h) Painful peripheral neuropathy ≥ grade 2.
    i) Any ongoing cancer-related coagulopathy disorder [other than medically treated deep venous thrombosis (DVT) during at least one month].
    2. Known central nervous system (CNS) metastatic involvement.
    3. Malignant or non-malignant ascitis ≥ grade 3.
    4. Primary histology other than squamous-cell carcinoma or adenocarcinoma.
    5. Prior treatment with elisidepsin or KF.
    6. Less than 50 kg of body weight (only for patients included in the dose optimization
    phase).
    7. Men or women of childbearing potential who are not using an effective method of
    contraception as previously described; women who are pregnant or breast feeding.
    8. High transfusional requirements (> 4 packages of red blood cells and/or one platelet transfusion) in the last four weeks prior to study entry.
    9. Participation in another clinical trial or concomitant treatment with any investigational product in the 4-week period prior to study entry.
    10. Patients with a prior invasive malignancy (except non-melanoma skin cancer) who
    have had any evidence of disease within the last three years.
    11. Major surgery performed or planned within four weeks of the start of study treatment (line placement is not considered major surgery).
    12. Patients with serious non-healing wound or ulcer. This includes history of abdominal fistula, gastrointestinal perforation, active uncontrolled bleeding or intraabdominal abscess during the last three months before study entry.
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    Rate of tumor control, defined as confirmed objective response of any duration or PFS-4 [absence of disease progression (clinical and/or radiological)] or death at Week 16 ± 1).

    Secondary efficacy endpoints
    - Progression-free survival rate at six months and one year (PFS-6 and 1-yr PFS), defined as the percentage of patients who are alive and with no evidence of disease progression at six months and one year after the date of randomization (or after the date of registration if only one of the two schedules proceeds to the Expansion stage), respectively.
    - Rate of response (RR), defined as the percentage of evaluable patients having at
    least PR or CR. Antitumor activity will be evaluated according to the RECIST, version 1.1, whenever applicable [by helical contrast enhanced computed tomography (CT) scan or magnetic resonance imaging (MRI), as appropriate] a minimum of eight weeks after initial therapy in all patients with measurable disease.
    - Duration of response (DR), defined as the time between the date when the response criteria (PR or CR, the first that is reached) are fulfilled and the first date
    when disease progression, recurrence or death is objectively documented (taking
    the smallest measurements documented since the treatment started as reference for
    progressive disease).
    - Progression-free survival (PFS), defined as the time from the date of randomization (or after the date of registration if only one of the two schedules proceeds to the Expansion stage) to the date of negative assessment (progression or death) or last tumor evaluation.
    - Overall survival (OS), defined as the time from the date of randomization (or after
    the date of registration if only one of the two schedules proceeds to the Expansion
    stage) to the date of death (or the last day when the patient is known to be alive),
    and rate of survival at one year (1-yr OS), defined as the percentage of patients
    who are alive at one year after the date of randomization (or after the date of registration if only one of the two schedules proceeds to the Expansion stage).
    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 No
    E.6.10Pharmacogenetic No
    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 Yes
    E.7.1.3.1Other trial type description
    Phase Ib - II
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Patients will receive the study medications while it is considered to be in their best interest.
    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 months6
    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 months6
    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.1.3Elderly (>=65 years) Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 126
    F.4.2.2In the whole clinical trial 126
    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 Decision2010-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-05-04
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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