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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2004-002782-20
    Sponsor's Protocol Code Number:H3E-MC-JMHH
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-09-26
    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 - BfArM
    A.2EudraCT number2004-002782-20
    A.3Full title of the trial
    A Phase 1 and 2 Clinical Trial of ALIMTA (Pemetrexed) in Combination with Carboplatin in Patients with Recurrent Ovarian or Primary Peritoneal Cancer
    A.4.1Sponsor's protocol code numberH3E-MC-JMHH
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot available
    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 SponsorEli Lilly and Company Limited
    B.1.3.4CountryUnited Kingdom
    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 Yes
    D.2.1.1.1Trade name ALIMTA
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V
    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.3.1Product nameALIMTA
    D.3.2Product code LY231514
    D.3.4Pharmaceutical form Powder 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 INNpemetrexed
    D.3.9.1CAS number 150399-23-8
    D.3.9.2Current sponsor codeLY231514 disodium
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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.2.1.1.1Trade name Carboplatin 50 mg Hexal
    D.2.1.1.2Name of the Marketing Authorisation holderHexal AG
    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 nameCarboplat 50-Lösung
    D.3.2Product code Carboplatin
    D.3.4Pharmaceutical form 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 INNCarboplatin
    D.3.9.1CAS number 41575-94-4
    D.3.9.2Current sponsor codeCarboplat-50-Lösung, Carboplat-150-Lösoung
    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 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
    platinum sensitive recurrent ovarian or primary peritoneal cancer
    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
    The primary objective of the Phase 1 portion of this study is to determine the MTD of the combination therapy of pemetrexed and carboplatin when administered to patients with platinum-sensitive recurrent ovarian cancer. Subsequent references to the study population (“patients with ovarian cancer”) will include the subpopulation of patients with primary peritoneal cancer.

    The primary objective of the Phase 2 portion of this study is to determine the overall tumor response rate of the combination therapy of pemetrexed and carboplatin when administered to patients with platinum-sensitive recurrent ovarian cancer. Subsequent references to the study population (“patients with ovarian cancer”) will include the subpopulation of patients with primary peritoneal cancer.
    E.2.2Secondary objectives of the trial
    Phase 1 :
    - to determine the dose limiting toxicities (DLT) of the combination therapy of pemetrexed and carboplatin in patients with platinum-sensitive recurrent ovarian cancer
    - to determine the quantitative and qualitative toxicities of pemetrexed in combination with carboplatin
    - to determine a recommended dose of the combination therapy of pemetrexed and carboplatin for future Phase 2 studies
    - to document the antitumor activity of pemetrexed and carboplatin in patients with platinum-sensitive recurrent ovarian cancer through tumor response assessment.

    Phase 2:
    - to determine the following time-to-event parameters
    o time to response
    o duration of response
    o time to objective disease progression
    o time to treatment failure
    o objective progression-free survival
    o overall survival.
    - to determine the safety and quantitative and qualitative toxicities
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in the study only if they meet all of the following criteria:
    [1] histologic diagnosis of ovarian or primary peritoneal cancer that is not amenable to curative therapy.
    [2] patients must have platinum-sensitive recurrent ovarian cancer.
    Platinum sensitive ovarian cancer is defined as disease that recurs at least 6 months after completion of prior platinum-based therapy. Best response to prior platinum-based therapy must have been CR, PR, SD, or not evaluable due to optimal debulking surgery.
    [3] prior radiation therapy is allowed, and patients must have recovered from the acute toxic effects of the treatment prior to study entry, but must have been completed at least 2 weeks prior to study enrollment. Prior radiation therapy must not have involved more than 25% of the bone marrow.
    [4] patients enrolling in the Phase 1 portion of the protocol may have either measurable or nonmeasurable disease as defined by Response Criteria in Solid Tumors (RECIST) guidelines. (Therasse et al. 2000; refer to Section 6.1.1.3)
    [5] patients enrolling in the Phase 2 portion of the protocol must have:
    - measurable disease as defined by the RECIST guidelines,
    or
    - nonmeasurable as defined by the RECIST guidelines but CA-125 ≥2X upper limit of normal at least 2 weeks prior to study enrollment (patients with “isolated CA-125 recurrence,” for purposes of this study).
    [6] performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale (Protocol Attachment JMHH.3).
    [7] estimated life expectancy of at least 24 weeks.
    [8] patient compliance and geographic proximity that allow adequate follow-up.
    [9] adequate organ function including the following:
    - adequate bone marrow reserve: absolute neutrophil count (ANC) ≥1.5 x 10e9/L, platelets ≥100 x 10e9/L, and hemoglobin ≥9 g/dL.
    - hepatic: bilirubin ≤1.5 times the upper limit of normal, alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤3.0 times normal (AP, AST, and ALT ≤5.0 times normal is acceptable if due to liver metastases).
    - renal: calculated creatinine clearance (CrCl) ≥45 mL/min based on the standard Cockcroft and Gault formula or on measured GFR using the appropriate radiolabeled method (51-CrEDTA or Tc99m-DTPA).
    [10] signed informed consent from patient or legal representative is required.
    [11] women at least 18 years of age.
    [12] patients with reproductive potential must use a reliable contraceptive method if appropriate (for example, intrauterine device [IUD], birth control pills, or barrier device) during the study. Patients with reproductive potential must have a negative urine pregnancy test within 7 days of study enrollment.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    [13] more than 2 line of therapy for ovarian or primary peritoneal cancer.
    This includes high-dose therapy, consolidation therapy, maintenance therapy, or noncytotoxic targeted agents. Noncytotoxic targeted agents include (but are not limited to) hormonal therapies, monoclonal antibodies, cytokines, small molecule inhibitors of signal transduction, or any other agents with anti-tumor activity.
    [14] pregnant or breast feeding.
    [15] serious concomitant systemic disorders (for example, active infection) that, in the opinion of the investigator, would compromise the safety of the patient and her ability to complete the study.
    [16] have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
    [17] inability to interrupt the use of aspirin and/or other nonsteroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents, such as piroxicam).
    [18] peripheral neuropathy ≥NCI Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 (see CTCAE Investigator Guide, Version 3.0).
    [19] inability or unwillingness to take folic acid and vitamin B12 supplementation, and corticosteroids.
    [20] previous completion of or withdrawal from this study or any other study investigating pemetrexed.
    [21] inability to comply with protocol or study procedures.
    [22] have a clinically significant third-space fluid (for example, pleural effusion or ascites) that cannot be managed with drainage.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1: Maximum tolerated dose
    Phase 2: Overall tumor response rate
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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
    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 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 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 No
    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.8.5The 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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    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 days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-09-26. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    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)
    Follow local treatment recommendations for that condition
    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 Decision2005-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-02-23
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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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