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    Summary
    EudraCT Number:2005-005535-10
    Sponsor's Protocol Code Number:H3E-MC-JMHX(c)
    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:2006-01-24
    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 number2005-005535-10
    A.3Full title of the trial
    A Phase 2 study of ALIMTA in solid tumor patients with stable third-space fluid
    A.4.1Sponsor's protocol code numberH3E-MC-JMHX(c)
    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 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 Information not present in EudraCT
    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
    either (1) relapsed, advanced (Stage III or IV) NSCLC or (2) malignant pleural or peritoneal mesothelioma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    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 this Phase 2 study is to evaluate the safety of pemetrexed in patients with third-space fluid (pleural effusions or ascites).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    • to identify the adverse event profile of pemetrexed in patients with third-space fluid according to the Common Terminology Criteria for Adverse Events (CTCAE; version 3.0 [NCI 2006])
    • to evaluate the pharmacokinetics of pemetrexed in patients with third-space fluid
    • to assess the clinical relevance of any alterations in pemetrexed pharmacokinetics in patients with third-space fluid
    • to provide pemetrexed dosing recommendations for patients with third-space fluid.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are eligible to be included in this study only if they meet all of the following criteria:
    [1] Histologic or cytologic diagnosis of locally advanced or metastatic (Stage III or IV at entry) NSCLC that is not amenable to curative therapy or histologic diagnosis of mesothelioma of the pleura or peritoneum that is not amenable to curative therapy.
    Patients with NSCLC must have been previously treated with one platinum-containing chemotherapy regimen for locally advanced or metastatic disease.
    Patients with malignant pleural or peritoneal mesothelioma may have received one previous chemotherapy regimen and, at the discretion of the investigator, be clinical candidates for treatment with single-agent pemetrexed.
    [2] Presence of clinically detectable (by physical exam) and stable-appearing third-space fluid (ascites or pleural effusions).
    [3] Measurable lesions are not required for enrollment in this study.
    [4] Prior anticancer treatment (except radiation) must be completed at least 3 weeks prior to study enrollment, and the patient must have recovered from the acute toxic effects of the regimen.
    [5] Prior radiation therapy is allowed to <25% of the bone marrow. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment.
    [6] An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. (Oken et al. 1982; see Protocol Attachment JMHX.3.)
    [7] Estimated life expectancy of at least 8 weeks.
    [8] Patient compliance and geographic proximity that allow adequate follow-up.
    [9] Adequate organ function that includes the following indices:
    Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) 1.5  109/L, platelets 100  109/L, and hemoglobin 9 g/dL.

    Hepatic: bilirubin 1.5  the upper limit of normal (ULN), alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) 3.0  ULN (ALP, AST, and ALT 5  ULN is acceptable if the liver has tumor involvement).

    Renal: calculated CrCl >45 mL/min using the original, weight-based Cockcroft and Gault formula (Cockcroft and Gault 1976; see Protocol Attachment JMHX.4). Creatinine clearance enrollment and dosing decisions will be based on local laboratory values. A patient will be enrolled using the local laboratory value. The same local laboratory should be used throughout the study for dosing decisions.

    [10] Signed informed consent from patient.
    [11] Males or females at least 18 years of age.
    [12] Male and female patients with reproductive potential must use an approved contraceptive method if appropriate (for example, intrauterine device, birth control pills, or barrier device) during, and for 6 months after, treatment. Females with childbearing potential must have a negative serum pregnancy test within 7 days before study enrollment.
    E.4Principal exclusion criteria
    Patients will be excluded from the study if they meet any of the following criteria:
    [13] 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.
    [14] Active infection that, in the opinion of the investigator, would compromise the patient’s ability to tolerate therapy.
    [15] Pregnant.
    [16] Breast-feeding.
    [17] Serious concomitant systemic disorders that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator.
    [18] Second primary malignancy that is clinically detectable at the time of consideration for study enrollment (with the exception of in situ carcinoma of the cervix, adequately treated basal cell carcinoma, and early stage prostate cancer with Gleason grade 6).
    [19] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose 1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
    [20] Brain metastases. Patients who are symptomatic for brain metastases must have a pretreatment computed tomography or magnetic resonance imaging (CT or MRI) of the brain. A patient with documented brain metastases at the time of study entry will be excluded from entering the study. Patients with prior brain metastases may be considered if they have completed their treatment for brain metastases, no longer require corticosteroids, and are asymptomatic.
    [21] Significant weight loss (that is, 10% of body weight) over the 6 weeks before study entry.
    [22] Inability or unwillingness to take folic acid, vitamin B12 supplementation, or a corticosteroid.
    [23] Have previously completed or withdrawn from this study or any other study investigating pemetrexed or have received any prior treatment with pemetrexed.
    [24] Have been exposed to yellow fever vaccine, and live attenuated vaccines.
    [25] Are taking oral anticoagulants.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this Phase 2 study is to evaluate the safety of pemetrexed in patients with third-space fluid (pleural effusions or ascites).

    Safety will be assessed through clinical adverse events and CTCAE laboratory and nonlaboratory toxicities. The CTCAE scale will be used. (version 3.0, NCI 2006). A CTCAE rating will be performed before each cycle for any adverse events experienced during previous cycle.

    Additionally, incidence of each of the following safety-related outcomes will be summarized:
    • extent of exposure to study drug treatment
    • number of blood transfusions required
    • discontinuations due to adverse events or death
    • deaths on study-drug treatment or within 30 days after last dose
    • adverse events on study-drug treatment or within 30 days after last dose
    • treatment-emergent adverse events.

    The Lilly clinical research physician will review SAEs within the time frames mandated by company procedures and will review trends, laboratory analytes, and adverse events at periodic intervals."
    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 No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.2Open Yes
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Last visit (approximately 30 days following patient discontinuation) 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 years1
    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 months20
    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 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 2006-01-24. Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    see CD ROM or binder, section 5
    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 Decision2007-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-11
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