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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-001461-32
    Sponsor's Protocol Code Number:OGX-011-12
    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:2012-05-25
    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 number2012-001461-32
    A.3Full title of the trial
    A Randomized Phase 3 Study Comparing Cabazitaxel/Prednisone in Combination with Custirsen (OGX-011) to Cabazitaxel/Prednisone for Second-Line Chemotherapy 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
    The trial is designed to determine the efficacy of Custirsen (OGX-011) in combination with Cabazitaxel/Prednisone versus Cabazitaxel/Prednisone alone in Men with Metastatic Castrate Resistant Prostate Cancer
    A.3.2Name or abbreviated title of the trial where available
    AFFINITY
    A.4.1Sponsor's protocol code numberOGX-011-12
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01578655
    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 SponsorOncoGenex Technologies Inc.
    B.1.3.4CountryCanada
    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 supportOncoGenex Technologies Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOncoGenex Pharmaceuticals Inc.
    B.5.2Functional name of contact pointCarol Bailey
    B.5.3 Address:
    B.5.3.1Street Address1522 217th Place SE, Suite 100
    B.5.3.2Town/ cityBothell, Washington
    B.5.3.3Post code98021
    B.5.3.4CountryUnited States
    B.5.4Telephone number001425 686 1533
    B.5.5Fax number001425 686 1600
    B.5.6E-mailCBailey@oncogenex.com
    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 sodium
    D.3.2Product code OGX-011/TV-1011
    D.3.4Pharmaceutical form Solution for injection/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 (sodium)
    D.3.9.1CAS number 685922-56-9
    D.3.9.2Current sponsor codeOGX-011
    D.3.9.3Other descriptive nameTV-1011
    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 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
    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 18.1
    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 18.1
    E.1.2Level PT
    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 defined as disease progression or death on or before Day 140.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Histological or cytological diagnosis of adenocarcinoma of the prostate

    2.Metastatic disease on chest, abdominal, or pelvic CT scan (CT preferred but MRI acceptable) and/or bone scan

    3.Previous first-line treatment for CRPC with a docetaxel-containing regimen. Patients must have received at least ≥225 mg/m2 of docetaxel (i.e., 3 cycles of 75 mg/m2).

    4.Current progressive disease defined by one or more of the criteria below:
    a.Progressive measurable disease by RECIST 1.1: At least a 20% increase in the sum of the diameters of measurable lesions over the smallest sum observed or the appearance of one or more new lesions as assessed by CT scan.
    OR
    b.Bone scan progression: Appearance of 2 or more new lesions on bone scan
    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. For patients who progress based only on increasing serum PSA level, a minimum starting value of 5.0 ng/mL is required for study randomization.

    5.Baseline laboratory values as stated below:
    a.ANC ≥ 1.5 x 10^9 cells /L
    b.Platelet count ≥ 125 x 10^9 /L
    c.Creatinine ≤ 1.5 x upper limit of normal (ULN)
    d.Bilirubin ≤ 1.1 x ULN (unless elevated secondary to conditions such as Gilbert’s disease)
    e.SGOT (AST) and SGPT (ALT) ≤ 1.5 x ULN
    f.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 (either agonists or antagonists) throughout the study, unless treated with bilateral orchiectomy

    7.Karnofsky score ≥ 70%

    8.At least 21 days have 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

    9.At least 21 days have passed since receiving any investigational agent at the time of randomization

    10.At least 21 days have passed since major surgery

    11.Has recovered from any docetaxel therapy-related neuropathy to ≤ grade 1 at the time of randomization

    12.Has recovered from all therapy related toxicity to ≤grade 2 (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy) at the time of randomization

    13.Able to tolerate a starting dose of 25 mg/m2 cabazitaxel

    14.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 associated toxicity)

    15.Able to tolerate oral prednisone at 10 mg per day. NOTE: If receiving more than 10 mg of prednisone per day (or steroid equivalent) at screening, must be able to have the dose reduced to 10 mg of prednisone per day prior to randomization and throughout study treatment. Patients not receiving prednisone at screening need to begin oral prednisone of 10 mg per day prior to or on the morning of Day 1 of Cycle 1.

    16.Competent and willing to provide written informed consent prior to any protocol-specific procedures being performed.
    E.4Principal exclusion criteria
    1.Received any other cytotoxic chemotherapy beyond the first-line docetaxel-containing regimen as treatment for prostate cancer

    2.Received prior radioisotope with strontium 89 or samarium 153

    3.Received any cycling, intermittent, or continuous hormonal treatment within 21 days prior to randomization with the exception of the continuous GnRH analogues required in Inclusion Criteria #6. Note: Prior treatment with abiraterone or MDV3100 is allowed as long as 21 days have passed since last dose.

    4.Participated in a prior Phase 3 clinical study evaluating custirsen regardless of study arm assignment (i.e. either control or investigational arm)

    5.Requiring ongoing treatment during the study with medications known to be either strong cytochrome P3A (CYP3A) inhibitors or strong CYP3A inducers (Refer to Section 6.5.10). NOTE: The washout period for these medications and St John’s Wort must be at least one week from randomization.

    6.History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated (Brain imaging for asymptomatic patients is not required).

    7.Current symptomatic cord compression requiring surgery or radiation therapy (Once successfully treated and there has been no progression, patients are eligible for the study).

    8.Active second malignancy, including lymphoid malignancies such as chronic lymphocytic leukemia or low grade lymphoma (except non melanomatous skin or superficial bladder cancer) defined in general as requiring anticancer therapy or at high risk of recurrence during the study

    9.Uncontrolled medical conditions such as diabetes mellitus, congestive heart failure, angina pectoris, serious cardiac arrhythmia, severe hypertension, or active infection requiring systemic antibiotics, or any event such as myocardial infarction, cerebrovascular accident, or pulmonary embolism within 3 months of randomization, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy

    10.Known severe hypersensitivity to taxanes or polysorbate 80-containing drugs

    11.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 is Survival time
    E.5.1.1Timepoint(s) of evaluation of this end point
    Survival time will be assessed for each patient from the date of randomization to the date of death from any cause.
    E.5.2Secondary end point(s)
    Alive Without Event (AWE) is determined if a patient is alive and found to be free of evidence of disease progression
    E.5.2.1Timepoint(s) of evaluation of this end point
    The status of each patient at approximately day 140 (window of Day~125-155) post randomization
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Comparing to background treatment without IMP
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Australia
    Canada
    Czech Republic
    France
    Hungary
    Russian Federation
    United Kingdom
    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
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months8
    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.1.2.1Number of subjects for this age range: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state59
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 238
    F.4.2.2In the whole clinical trial 630
    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)
    All patients given standard of care after their participation in the trial
    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 Decision2012-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-07-15
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