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    Summary
    EudraCT Number:2006-002316-10
    Sponsor's Protocol Code Number:H6Q-MC-S019(b)
    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:2006-08-07
    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 number2006-002316-10
    A.3Full title of the trial
    A Randomized, Phase 2, Placebo-Controlled, Double-Blinded Study With and Without Enzastaurin in Combination With Paclitaxel and Carboplatin as First-Line Treatment, Followed by Maintenance Treatment in Advanced Ovarian Cancer
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberH6Q-MC-S019(b)
    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 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 nameEnzastaurin
    D.3.2Product code LY317615
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEnzastaurin Hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1125
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with a histologic diagnosis of FIGO Stage IIB, IIC, III, or IV advanced invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10033130
    E.1.2Term Ovarian cancer NOS
    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 is to compare the antitumor activity in first-line therapy of paclitaxel- and carboplatin-combination therapy plus enzastaurin followed by enzastaurin maintenance therapy (Regimen A), versus paclitaxel- and carboplatin-combination therapy plus placebo followed by placebo as a maintenance (Regimen B), as measured by progression-free survival (PFS), in patients with advanced ovarian cancer (FIGO Stage IIB-IV ovarian, fallopian tube or peritoneal epithelial carcinoma).
    E.2.2Secondary objectives of the trial
    • to compare the response rates (RR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria and CA-125 according to GCIG criteria between Regimen A and Regimen B: Rate of complete response (CR), partial response (PR), and stable disease (SD)
    • to compare safety and adverse event profiles (including the Common Terminology Criteria for Adverse Events [CTCAE Version 3.0, NCI 2003] grades for laboratory and nonlaboratory AEs, between Regimen A and Regimen B
    • to evaluate the pharmacogenomics and biological markers for enzastaurin (for example: PKCβ, GSK-3β, PI3K/AKT, S6K) and the effect of enzastaurin on these molecular markers compared to patients receiving placebo
    • to determine if enzastaurin alters carboplatin and paclitaxel pharmacokinetics (PK) when administered in combination
    • to characterize the PK of enzastaurin using intensive sampling in Part 1 (safety lead-in) and sparse sampling in the randomized Part 2 of trial.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - present with a histologic diagnosis of FIGO Stage IIB, IIC, III, or IV advanced invasive epithelial ovarian, fallopian tube, or peritoneal carcinoma.
    - should be primarily optimal debulked (0 cm residual tumor) or sub-optimal debulked (>0 cm residual tumor).
    - must be enrolled within six weeks after laparotomy, but should not start treatment with chemotherapy or enzastaurin/placebo earlier than 3 weeks; and have recovered from surgery sufficiently to start study therapy.
    - are women, who are at least 18 years of age.
    - have an ECOG performance status of 0, 1, or 2.
    - have adequate organ function including the following: Adequate bone marrow reserve and Hepatic and Renal functioning.
    - signed informed consent
    - Reproductive potential of women must be surgically sterile, postmenopausal,
    or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after the treatment period; women with reproductive potential must have a negative serum or urine pregnancy test within 3 days before study enrollment and must not be breast-feeding.
    E.4Principal exclusion criteria
    - 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.
    - receive concurrent administration of any other systemic anticancer therapy. Receive simultaneous administration of hormonal therapy during the study treatment period (hormone replacement therapy is allowed, as are steroid antiemetics).
    - receive concurrent radiation therapy during the study treatment period.
    - patients with a history of hypersensitivity reactions to products containing Cremophor EL (cyclosporine, castor oil, or vitamin K) and/or patients with known hypersensitivity to compounds chemically related to carboplatin, paclitaxel, or enzastaurin.
    - are unable to discontinue concurrent administration of carbamazepine, phenobarbital, or phenytoin at least 14 days prior to study therapy.
    - have an active infection, including active bacterial, fungal, or viral infection (at the discretion of the investigator), as well as other serious concomitant systemic disorders (for example, active infection including HIV, or cardiac disease) that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol.
    - have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV. Patients with a QTc prolongation >470msec and patients who have a congenital long-QT-syndrome in their own or family medical history should be excluded.
    - have a second primary malignancy (except adequately treated basal cell carcinoma of the skin) or a prior diagnosis of any malignancy less than 5 years before study entry (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin).
    - have a history of central nervous system (CNS) disorder or metastases (unless the patient has completed successful local therapy for CNS metastases and has been off corticosteroids for at least 4 weeks before starting study therapy). A screening computed tomography (CT) or magnetic resonance imaging (MRI) before enrollment in the absence of a clinical suspicion of brain metastases is not required.
    - Are unable to swallow tablets.
    - are pregnant, breast feeding, or not using adequate contraceptive methods to prevent pregnancy.
    E.5 End points
    E.5.1Primary end point(s)
    At the time of Protocol Amendment S019(b) being implemented, 142 patients were
    randomized in a 1:1 fashion. Given the status of the data and that the change of the
    primary endpoint would lead to a more robust and informative analysis, the primary
    endpoint will be changed from the PFS rate at 18 months to the estimate of PFS.
    The original hypothesis stated an increase from 50% to 60% at 18 months was translated
    into an over 36% increase in the median time from 18 to 24.4 months. So, under the
    assumption that the true PFS (HR) is 0.737 (36% increase in the median), 32 events
    (progression or death) will be needed to have 70% power to detect at least a 12.5%
    increase in median PFS.
    This sample size will allow the detection of which regimen achieves a
    numerically superior PFS. The Type 1 error, or “alpha” error, is not
    controlled with respect to this selection.
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned3
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Patients remain until last maintenance (Max 3 years) therapy plus 30 days follow-up until progression, unacceptable AE's or unblinding. Unblinding will occur when at least 32 events (progression/death) have been documented.
    After unblinding: for patients that were already in post-study follow up prior to unblinding, post study follow up visit collection will be stopped. Patients that were treated with placebo will be discontinued and Visit 801 will be the last collected for these patients.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    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 No
    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 2006-08-07. 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 149
    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 Decision2006-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-11
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