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    Summary
    EudraCT Number:2008-002730-30
    Sponsor's Protocol Code Number:IB 2008-23
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-19
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2008-002730-30
    A.3Full title of the trial
    A PHASE II TRIAL TO ASSESS THE EFFICACY OF EFAVIRENZ IN METASTATIC PATIENTS WITH ANDROGEN-INDEPENDENT PROSTATE CANCER
    A.3.2Name or abbreviated title of the trial where available
    FAVE
    A.4.1Sponsor's protocol code numberIB 2008-23
    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 SponsorInstitut Bergonié - Centre Régional de Lutte Contre le Cancer de Bordeaux et du Sud-ouest
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 SUSTIVA® 200 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB
    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 nameEfavirenz
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    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
    Male patients aged 18 and over with castration-refractory metastatic prostate cancer histologically confirmed with WHO performance status ranged from 0 to 2, and without any clinical symptom related to disease progression.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036947
    E.1.2Term Prostatic cancer metastatic
    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 study is to assess the effect of efavirenz on the non-PSA progression at 3 months in patients with castration-refractory metastatic prostate cancer, without any clinical symptom related to disease progression.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to investigate:

    - the effect of efavirenz on the PSA response at 3 months,
    - the effect of efavirenz on the overall survival,
    - the effect of efavirenz on the PSA progression-free survival,
    - the effect of efavirenz on the symptomatic progression-free survival,
    - the tolerability and safety profile of efavirenz.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Etudes optionnelles :

    · Dosage du niveau de méthylation de LINE 1 dans un échantillon sanguin.
    · Dosage de l’Efavirenz sanguin.
    E.3Principal inclusion criteria
    1. Provision of written informed consent prior any study-related procedures.
    2. Male aged 18 years and over.
    3. Previously confirmed histological diagnosis of prostate adenocarcinoma.
    4. Evidence of metastases (including bone, lymph nodes, or other site), radiologically or histologically documented.
    5. Despite a serum testosterone level inferior or equal to 50 ng/dL proving castration, evidence of biochemical progression of prostate cancer, documented by a rise in PSA that meets all the following criteria:
    a. 3 consecutive dosages of PSA, each of them showing an increase of the PSA value compared to the previous dosage (if the third PSA value is lower than the second PSA value, a fourth PSA assessment is required and the PSA value should be higher than the second PSA value)
    b. 2 weeks minimum time interval between sampling
    c. All PSA values must be equal or higher than 5 ng/mL and should have been assessed in the same laboratory using the same PSA assay
    6. Word Health Organisation (WHO) performance status ranged from 0 to 2 (see Appendix 1).
    7. No prior cytotoxic chemotherapy for the treatment of prostate cancer.
    8. No clinical symptom related to disease progression: no bone pain related to bone metastasis, no change in the urinary symptoms during the last 6 months.
    9. Treated with luteinising hormone-releasing hormone (LHRH) analogue and peripheral antiandrogens for 6 months at least and confirmation of the initial tumoral response at the start of this treatment. Continued elevation of the PSA can be demonstrated during the washout times provided above.
    10. Withdrawal of antiandrogens, at least 6 weeks before inclusion in the study. LH-RH analogue should be maintained.
    11. Biphosphonate therapy is allowed if the first dose was administered more than 30 days before inclusion.
    12. Patients with French Social Security in compliance with the French law relating to biomedical research (Huriet Law 88-1138 and related decrees).
    E.4Principal exclusion criteria
    1. No metastatic prostate cancer or no resistance to castration or symptomatic prostate cancer.
    2. Radiotherapy or surgery or antiandrogens (except LHRH analogue) or bilateral orchiectomy within the 30 days preceding inclusion visit. Incompletely healed surgical incision.
    3. Concomitant anticancer therapy other than surgical castration or continuous medical castration.
    4. Previous treatment with chemotherapy including taxans or estracyt®.
    5. Biology:
    a. Neutrophils < 1.5 × 109/L or platelets < 100 × 109/L
    b. Serum creatinine > 1.5 × the upper limit of reference range (ULRR) or creatinine clearance ≤ 60 mL/ minute (calculated by the Cockcroft-Gault formula)
    c. Potassium < 4.0 mmol/L despite supplementation; serum calcium (ionized calcium level or adjusted for albumin) or magnesium below the normal range despite supplementation
    d. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULRR; alkaline phosphatase (ALP) > 2.5 × ULRR, or > 5 × ULRR if judged by investigator to be related to liver metastasis; serum bilirubine > 1.5 × ULRR.
    6. Human Immunodeficiency Virus (HIV) positive.
    7. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. currently unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) or evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study.
    8. Previous or current malignancies other than prostate cancer within the last 5 years, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin.
    9. Known hypersensitivity to study treatment and to their excipients.
    10. Severe hepatic impairment.
    11. Concomitant treatment with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, rye alkaloids, voriconazole, herbal extract from St. John's wort (Hypericum perforatum).
    12. Depressive status (with a score ≥ 13 on the HAD scale).
    13. Any unresolved toxicity greater than CTC grade 1 from previous anti-cancer therapy.
    14. Currently active diarrhoea that may affect the ability of the patient to absorb the study treatment.
    15. Previous exposure or any previous treatment acting on signal transduction pathway.
    16. Participation in a clinical study and / or receipt of an investigational drug during the last 30 days.
    17. Previous enrolment in the present study.
    18. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.
    E.5 End points
    E.5.1Primary end point(s)
    The non-PSA progression rate at 3 months and PSA 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 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 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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned6
    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 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
    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
    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 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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    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 Decision2008-08-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
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