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    Summary
    EudraCT Number:2010-021011-16
    Sponsor's Protocol Code Number:OGX-011-11
    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:2010-08-17
    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 number2010-021011-16
    A.3Full title of the trial
    A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination with Custirsen (OGX-011) in Men with Metastatic Castrate Resistant Prostate Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to find out if being treated with Docetaxel, Prednisone and Custirsen (new experimental study drug) can increase survival in patients with metastatic, castrate resistant prostate cancer compared to the currently approved treatment with Docetaxel and Prednisone. The study will also see if Custirsen is safe when given with Docetacel and Prednisone.
    A.3.2Name or abbreviated title of the trial where available
    SYNERGY
    A.4.1Sponsor's protocol code numberOGX-011-11
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTeva Pharmaceutical Industries, Ltd
    B.1.3.4CountryUnited States
    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 supportTeva Pharmaceutical Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Pharma GmbH
    B.5.2Functional name of contact pointMiriam Mertz
    B.5.3 Address:
    B.5.3.1Street AddressWaldecker Str. 7
    B.5.3.2Town/ cityMoerfekden-Walldorf
    B.5.3.3Post code64546
    B.5.3.4CountryGermany
    B.5.4Telephone number004961059767687
    B.5.5Fax number004961059767632
    B.5.6E-mailmiriam.mertz@teva.de
    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 nameCustirsen 20mg/ml concentrate for solution for infusion
    D.3.2Product code OGX-011, TV-011
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNcustirsen
    D.3.9.1CAS number 685922-56-9
    D.3.9.2Current sponsor codeOGX-011, TV-011
    D.3.9.3Other descriptive nameCustirsen 20mg/ml concentrate for solution for infusion
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Yes
    D.3.11.13.1Other medicinal product typeantisense oligonucleotide
    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
    metastatic castrate resistant prostate cancer
    E.1.1.1Medical condition in easily understood language
    metastatic castrate resistant prostate cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10062904
    E.1.2Term Hormone-refractory prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To ascertain whether the survival time distribution for patients randomized to the investigational arm is consistent with longer survival as compared to patients randomized to the control arm.
    E.2.2Secondary objectives of the trial
    To compare the arms with respect to the proportion of patients having a milestone Day 140 status of alive without event (within the window of Day 125-155 post randomization). An event is having disease progression or death on or before Day 140. NOTE: Day 140, as measured from the date of randomization, will occur normally after Cycle 6 (prior to Cycle 7) study treatment. However, the milestone Day 140 disease assessment must be completed within the inclusive window of Day 125 to Day 155 post-randomization, regardless of the timing of Cycle 6 treatment (e.g., if treatment scheduling at any time has been delayed).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A. Supplemental Protocol OGX-011-11SP, version1.2, 15 Mar 2012

    Pharmacokinetic and Cardiac Monitoring Study Supplement to Protocol OGX-011-11: A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination with Custirsen (OGX-011) in Men with Metastatic Castrate Resistant Prostate Cancer

    Objectives:
    - to determine if custirsen co-administered with docetaxel alters ECG intervals and morphology with special emphasis on changes in the QTcF interval duration.
    - to explore if co-administration of docetaxel and custirsen alters the pharmacokinetics of docetaxel.


    B. Surrogate marker Circulating Tumor Cells (CTC) Evaluations (CTC sub-study):
    The surrogate marker evaluation using CTC sub-study to the OGX-011-11 protocol version 1.3 will allow an evaluation of baseline prognosis and to identify subsets of patients who may benefit the most from Custirsen therapy, and may support findings of a positive overall survival benefit in the absence of differences in other traditional indicators of disease response. Since study OGX-011-11 is ongoing, not all subjects will participate in these evaluations.

    E.3Principal inclusion criteria
    Subjects must meet ALL of the following criteria to be eligible for inclusion into the study:
    1.Age ≥ 18 years on the date of consent.
    2.Histological or cytological diagnosis of adenocarcinoma of the prostate.
    3.Metastatic disease on chest, abdominal, or pelvic CT and/or bone scan.
    4.Systemic chemotherapy indicated due to progression while on or after androgen ablative therapy defined as:
    a.Progressive measurable disease: at least a 20% increase in the sum of the longest diameters of measurable lesions over the smallest sum observed –or the appearance of one or more new lesions as assessed by CT scan during hormone ablation treatment. Measurable lesions are nodal or visceral soft-tissue lesions with nodal lesions ≥ 20 mm in diameter or visceral/soft-tissue lesions ≥ 10 mm in diameter (see Section 6.3.1.1).
    OR
    b.Bone Scan Progression: appearance of 2 or more new lesions on bone scan during hormone ablation treatment.
    OR
    c.Increasing serum PSA level: Two consecutive increases in PSA levels documented over a previous reference value obtained at least one week apart are required. If the third PSA value is less than the second, an additional fourth test to confirm a rising PSA is acceptable. A minimum starting value of 5.0 ng/mL is required for study randomization.
    NOTE: Androgen ablative therapy may have included either medical or surgical castration.
    5.Baseline laboratory values as stated below:
    a.Creatinine ≤ 1.5 x upper limit of normal (ULN).
    b.Bilirubin ≤ 1.1 x ULN (unless elevated secondary to conditions such as Gilbert’s disease).
    c.SGOT (AST) and SGPT (ALT) ≤ 1.5 x ULN.
    d.Castrate serum testosterone level (< 50 ng/dL-or-< 1.7 nmol/L).
    6.Must be willing to continue primary androgen suppression with gonadotropin-releasing hormone (GnRH) analogues throughout the study, unless treated with bilateral orchiectomy.
    7.Adequate bone marrow function defined at screening as ANC ≥ 1.5 x 109 cells /L and platelet count ≥ 100 x 109 /L.
    8.Karnofsky score ≥ 70% (see Appendix 17.2).
    9.At least 28 days has passed since completing radiotherapy (exception for radiotherapy: at least 7 days since completing a single fraction of ≤ 800 cGy to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of randomization.
    10.At least 4 weeks have passed since receiving any investigational agent at the time of randomization.
    11.Has recovered from any other therapy related toxicity to ≤ grade 2, (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy).
    12.Patient must be willing to not add, delete or change their current bisphosphonate or denosumab usage throughout study treatment to assure that adverse event reporting is not confounded by changing their bisphosphonate or denosumab usage (unless withdrawn or changed as a result of bisphosphonate or denosumab assocuated toxicity).
    13.Patients receiving more than 10 mg of prednisone per day (or steroid equivalent) at screening must be willing to have the dose reduced to 10 mg of prednisone per day for at least 7 days prior to randomization and maintained throughout study treatment.
    14.Written informed consent must be obtained prior to any protocol-specific procedures being performed.
    E.4Principal exclusion criteria
    Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion into the study:
    1.Received any other cytotoxic chemotherapy as treatment for prostate cancer.
    2.Received any cycling, intermittent or continuous hormonal treatment 28 days prior to randomization with the exception of the continuous analogues required in Inclusion Criteria #6.
    3.Participated in a prior clinical study evaluating custirsen.
    4.History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated. (Brain imaging for asymptomatic patients is not required.)
    5.Current symptomatic cord compression requiring surgery or radiation therapy. (Once successfully treated and there has been no progression, patients are eligible for the study.)
    6.Active second malignancy (except non melanomatous skin or superficial bladder cancer) defined as requiring anticancer therapy or at high risk of recurrence during the study.
    7.Uncontrolled medical conditions such as heart failure, myocardial infarction, uncontrolled hypertension, stroke or treatment of a major active infection within 3 months of randomization, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy.
    8.Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint: Survival time distribution: Survival will be assessed for each patient from the date of randomization to the date of death from any cause.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Survival will be assessed for each patient from the date of randomization to the date of death from nany cause.
    E.5.2Secondary end point(s)
    The status of each patient at approximately Day 140 (window of Day 125-155) post-randomization is to be recorded as alive without event or not (binary outcome) in order to compute the arm-specific proportion of patients who are alive without event at approximately Day 140.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately at Day 140
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    standard of care treatment: docetaxel (75 mg/M2) + prednisone(5mg BD)
    E.8.2.4Number of treatment arms in the trial2
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA83
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Israel
    Korea, Republic of
    United States
    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 should receive study treatment until disease progression, unacceptable toxicity, or completion of 10 cycles is documented.
    All randomized patients will be followed for survival status and date of death.

    All patients who are randomized in the study and receive at least one dose of study treatment (custirsen or docetaxel) must complete an End of Treatment visit. This visit/assessment should be within 21 (± 7) days from withdrawal of study treatment.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 313
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 687
    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 state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 1000
    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)
    Following completion of the End of Treatment visit, the patient will either enter the Off Treatment Follow up Period or the Survival Period, depending on whether they have documented disease progression.
    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 Decision2010-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-30
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