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    Summary
    EudraCT Number:2006-004486-34
    Sponsor's Protocol Code Number:H6Q-MC-S001(a)
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-09-29
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-004486-34
    A.3Full title of the trial
    An Open-Label Study of Oral Enzastaurin HCI in Patients with Advanced or Metastatic Malignancies
    A.4.1Sponsor's protocol code numberH6Q-MC-S001(a)
    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.3.9.2Current sponsor codeLY317615
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    Have a histologic or cytologic diagnosis of advanced or metastatic malignancies for which no life-prolonging therapy exists and have been previously enrolled and completed therapy in an enzastaurin clinical pharmacology and biopharmaceutics study.
    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
    To collect further basic safety data on patients with advanced or metastatic malignancies treated with enzastaurin.
    E.2.2Secondary objectives of the trial
    To document antitumor activity that may be observed with enzastaurin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Have previously been enrolled and completed protocol therapy in an enzastaurin clinical pharmacology and biopharmaceutics study.
    [2] Have a histologic or cytologic diagnosis of advanced or metastatic malignancies or which no life-prolonging therapy exists. This may include patients with treated, stable brain metastases.
    [3] Have measurable or non-measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) (Protocol Attachment S001.4).
    [4] Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale (Protocol Attachment S001.2).
    [5] Have adequate bone marrow reserve and organ function as follows:
    • Absolute neutrophil count (ANC) >1.5 x 109/L and platelets >100 x 109/L.
    • Hepatic: Total bilirubin <2 times upper limits of normal (ULN), ALT, and AST <3 times ULN (or <5 times ULN in case of known liver involvement).
    • Renal: serum creatinine <1.5 mg/dL.
    [6] Have discontinued all previous therapies for cancer, except for protocol therapy from a lead-in study (that is, JCAV, JCAY, or another enzastaurin clinical pharmacology and biopharmaceutics study). Any other previous therapies including chemotherapy, radiotherapy, anticancer hormone therapy, or other investigational therapy must be discontinued for at least 4 weeks prior to study enrollment and patient must have recovered from any acute effects of previous treatment.
    [7] Reproductive potential must be either terminated (by surgery, radiation, or menopause) or attenuated by the use of an approved contraceptive method including intrauterine or barrier devices) during and for 3 to 6 months following the study.
    [8] Men and women at least 18 years of age.
    [9] Have given written informed consent.
    [10] Exhibit patient compliance and geographic proximity that allow for adequate follow-up.
    E.4Principal exclusion criteria
    [11] Have received treatment within the last 30 days with a drug other than enzastaurin that has not received regulatory approval for any indication at the time of study entry.
    [12] Women who are pregnant or breastfeeding.
    [13] Symptomatic central nervous system (CNS) neoplasm. (Patients who have stable CNS neoplasm on steroid medication may be included.)
    [14] Serious concomitant disorder, including active bacterial, fungal, or viral infection, incompatible with the study (at the discretion of the investigator).
    [15] Second primary malignancy that could affect compliance with the protocol or interpretation of the results. Patients with adequately treated basal cell carcinoma of the skin or who have had another malignancy in the past, but have been disease-free for more than 2 years, are eligible.
    [16] Electrocardiogram (ECG) abnormalities indicative of cardiac disease (at the discretion of the investigator).
    [17] For patients receiving EIAEDs: Patients must discontinue EIAEDs at least 14 days prior to study enrollment. The investigator may prescribe non-EIAEDs (see Attachment S001.5). However if a patient requires EIAED therapy while on study, the patient will not be discontinued from the study.
    [18] Inability to swallow tablets.
    [19] Concurrent administration of any other antitumor therapy.
    E.5 End points
    E.5.1Primary end point(s)
    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 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 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
    Safety/Efficacy extension study
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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 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 continue to receive enzastaurin until it is approved for marketing for the respective indication, until disease progression, unacceptable toxicity, or other criteria (as specified in Section 4.3) apply, or until Lilly stops the study.

    The end of the trial is defined as the last visit of the last patient undergoing the trial. This visit will occur within approximately 30 days following the last enzastaurin dose, when another therapy is initiated, or when the patient dies.
    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
    E.8.9.2In all countries concerned by the trial years3
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    Reasonable efforts will be made to follow any patient with an ongoing complete response (CR) or partial response (PR) at the time of study discontinuation. In appropriate patients, tumor measurements and imaging studies will be performed at 4 to 8 week intervals up until 30 days after final enzastaurin dose, when another therapy is initiated, when there is disease progression, or when the patient dies. All patients will be evaluated for ECOG performance status at the poststudy follow-up visit.
    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 Decision2006-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-07-29
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