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    Summary
    EudraCT Number:2005-004271-37
    Sponsor's Protocol Code Number:E7389-G000-204
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-04-24
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2005-004271-37
    A.3Full title of the trial
    A Phase II Multicenter, Open Label, Two-Stage Design Study Evaluating
    E7389 in Patients with Hormone Refractory Prostate Cancer with
    Advanced and/or Metastatic Disease Stratified by Prior Chemotherapy.
    A.3.2Name or abbreviated title of the trial where available
    E7389-G000-204
    A.4.1Sponsor's protocol code numberE7389-G000-204
    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 SponsorEisai 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 Information not present in EudraCT
    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.3.2Product code E7389
    D.3.4Pharmaceutical form Solution for injection
    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.3.9.1CAS number 441045-17-6
    D.3.9.2Current sponsor codeE7389
    D.3.9.3Other descriptive nameBOLD
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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 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
    Advanced/metastatic hormone-refractory prostate 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 study is to evaluate the efficacy of E7389 in the treatment of patients with advanced/metastatic hormone-refractory prostate cancer with and without prior chemotherapy with a tubulin-binding agent such as docetaxel.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the safety of E7389 when administered as a bolus infusion in the treatment of patients with advanced/metastatic hormone-refractory prostate cancer with and without prior chemotherapy with a tubulin-binding agent such as docetaxel.

    When possible, pharmacogenomic analysis will be carried out to explore the relationships between clinical response to E7389 and the expression of alpha- and beta-tubulin isotypes, tau, stathmin, and MAP4, (as well as to describe potential mutations in the corresponding genes in tumors).
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Males with histologically proven adenocarcinoma of the prostate that has progressed (a minimum of three consecutive rises in PSA (with the last value ≥ 4 ng/mL) taken at least one week apart prior to study entry) despite castration or maintenance of castrate-level testosterone (defined as serum testosterone ≤ 50 ng/dL or 1.7 nmol/L) during non-hormonal chemotherapy.

    Note: Patients previously treated with an antiandrogen must have disease progression documented after antiandrogen withdrawal. Those who have not undergone orchiectomy must continue medical castration with a gonadotropin-releasing hormone analog. At least 4 weeks must have elapsed between the withdrawal of antiandrogens (six weeks in the case of nilutamide or bicalutamide and four weeks in the case of flutamide or other secondary hormonal therapy) and enrollment, so as to avoid the possibility of confounding results of the response due to antiandrogen withdrawal.

    2. Patients must fulfill one of the following two criteria to be stratified:
    • No prior chemotherapy (except mitoxanthrone) for advanced and/or metastatic
    disease as defined in inclusion criteria #1
    • Failure of no more than one previous chemotherapeutic regimen with tubulin binding agents such as docetaxel.

    3. Resolution of all chemotherapy or radiation-related toxicities to less than grade 2 severity, except neuropathy and alopecia.

    4. Age ≥ 18 years.

    5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.

    6. Life expectancy of ≥ 3 months.

    7. Adequate renal function as evidenced by serum creatinine ≤ 1.5 times ULN (upper limit of normal) or calculated creatinine clearance ≥ 40 mL/minute (min) per the Cockcroft and Gault formula.

    8. Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥ 1.5 x 10(9)/L, hemoglobin ≥ 9.0 g/dL (or 5.5 mmol/L), and platelet count ≥ 100 x 10(9)/L. Adequate liver function as evidenced by bilirubin ≤ 1.5 x ULN, alanine transaminase (ALT), and aspartate transaminase (AST) ≤ 3 x ULN (in the case of liver metastases ≤ 5 x ULN).

    9. Patients willing and able to complete the VAS.

    10. Patients willing and able to comply with the study protocol for the duration of the study.

    11. Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
    E.4Principal exclusion criteria
    1. Patients who have received chemotherapy, radiation, or experimental therapy within 4 weeks of start of E7389 treatment.

    2. Radiation therapy encompassing ≥30% of marrow or treatment with the radioactive strontium.

    3. Patients who require therapeutic anti-coagulant therapy with warfarin or related
    compounds; (mini dose warfarin or related compounds are permitted).

    4. Severe / uncontrolled intercurrent illness/infection.

    5. Significant cardiovascular impairment (history of congestive heart failure > NYHA
    grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia.

    6. Patients with organ allografts.

    7. Patients with known immunosuppression, such as positive HIV status.

    8. Patients who have had a prior malignancy, other than non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated ≥ 5 years previously with no subsequent evidence of recurrence.

    9. Patients with pre-existing neuropathy > Grade 2.

    10. Patients with brain or subdural metastases are not eligible, except if they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least two weeks before starting treatment with E7389.

    11. Patients with meningeal carcinomatosis.

    12. Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical
    derivative.

    13. Patients who participated in a prior E7389 clinical trial.

    14. Patients with other significant disease or disorders that, in the Investigator’s opinion, would exclude the patient from the study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint
    The primary efficacy endpoint is PSA Response: post-therapy declines in PSA of ≥50% will be confirmed as per Bubley criteria. Declines of less than 50% and increases of no more than 25% will be reported as Stable Disease.

    Secondary efficacy endpoint
    The secondary efficacy endpoint is duration of PSA response.

    Tertiary efficacy endpoints
    • Tumor Related Symptom Assessments measured by a visual analog scale (VAS),
    analgesic consumption, ECOG performance status, and weight change.
    • Progression Free Survival: Progressive disease will be defined as either an increase in PSA of at least 25%, an increase of the absolute value of PSA by at least 5 ng/mL, an increase in measurable disease as per RECIST, or clinical progression.
    • Objective tumor response rates (CR, PR, SD and PD) in patients with measurable
    disease will be determined based on RECIST criteria.

    Safety endpoints
    • Adverse Events
    • Laboratory parameters
    • Concomitant medication
    • Study drug exposure
    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 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) 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 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.8.5The trial involves multiple Member States Yes
    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 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
    The end of study is defined as the final visit of the last patient (within 30 days after the last treatment intake).
    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 years1
    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 No
    F.2.2Male Yes
    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 No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 110
    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 Decision2006-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-02-18
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