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    Summary
    EudraCT Number:2011-002424-41
    Sponsor's Protocol Code Number:OGX-427-02
    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:2011-08-24
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-002424-41
    A.3Full title of the trial
    A Randomized, Double-blind Phase 2 Study Comparing Gemcitabine and Cisplatin in Combination with OGX-427 or Placebo in Patients With Advanced Transitional Cell Carcinoma
    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 OGX-427 Vs placebo in combination with Gemcitabine and Cisplatin in patients with Urinary tract cancer.
    A.4.1Sponsor's protocol code numberOGX-427-02
    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.1.3.4CountryUnited 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 supportOncoGenex Technologies, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOncoGenex Technologies, Inc.
    B.5.2Functional name of contact pointMonica Krieger
    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 number1425686 1558
    B.5.5Fax number1425686 1600
    B.5.6E-mailMKrieger@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.3.2Product code OGX-427
    D.3.4Pharmaceutical form 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 INNNot applicable
    D.3.9.1CAS number 915443-09-3
    D.3.9.2Current sponsor codeOGX-427
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic or locally inoperable, advanced (T4b, N2, N3 or M1) transitional cell carcinoma (TCC) of the urinary tract (bladder, urethra, ureter and renal pelvis)
    E.1.1.1Medical condition in easily understood language
    Metastatic or locally inoperable, advanced Urinary tract cancer.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10005084
    E.1.2Term Bladder transitional cell carcinoma
    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 there is evidence of longer survival relative to the control arm for three comparisons: 600 mg OGX-427 Arm to control Arm; 1000 mg OGX-427 Arm to control Arm; and pooled 600 mg and 1000 mg OGX-427 Arms to control Arm.
    E.2.2Secondary objectives of the trial
    • To compare the safety and tolerability of placebo, 600 mg of OGX-427, and 1000 mg of OGX-427 in combination with gemcitabine plus cisplatin.
    • To select the optimal dose of OGX-427 (600 mg vs. 1000 mg) for Phase 3 studies based on the safety and efficacy (i.e., risk/benefit).
    • To compare ORR (CR+PR), disease control rate (CR+PR+stable disease), duration of response, and PFS between the arms.
    • To evaluate the effect of therapy with gemcitabine, cisplatin and OGX-427 on serum Hsp27 levels, serum clusterin levels and CTC counts.
    • To evaluate and compare the number of circulating tumor cells (CTC) at baseline, the minimum CTC count during treatment and the maximum change in CTC count over time between arms.
    • To evaluate the effect of repeat OGX-427 dosing on serum OGX-427 Cmax and trough levels.
    • To evaluate for PTEN loss, translocation or deletion, along with downstream targets, in correlation with clinical response and changes in clusterin and Hsp27 levels.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Age ≥ 18 years at the time of consent.
    2) Histologically documented metastatic or locally inoperable advanced TCC of the urinary tract (bladder, urethra, ureter and renal pelvis) (T4b, N2, N3 or M1 disease).
    NOTE: Certain mixed histologies that are predominately (≥ 50%) TCC are eligible: squamous, adenocarcinoma, and undifferentiated. Mixed undifferentiated histology requires IHC consistent with a TCC origin. Mixed small-cell histologies are excluded.
    3) Measurable disease defined as at least one target lesion that has not been irradiated and can be accurately measured in at least one dimension by RECIST 1.1 criteria.
    4) No prior systemic chemotherapy with the following exceptions:
    • Prior use of radiosensitizing single agent therapy is allowed.
    • Prior neoadjuvant and adjuvant systemic chemotherapy are permissible if the interval from the end of therapy to the diagnosis of metastatic disease is at least 12 months.
    5) Minimum of 21 days have elapsed since prior major surgery or radiation therapy, with recovery from any adverse events.
    6) Karnofsky performance status ≥70%.
    7) Required laboratory values at baseline:
    • ANC ≥ 1.5x10^9 cells/L
    • platelet count ≥ 125 x 10^9/L
    • Calculated creatinine clearance ≥60 mL/minute (by modified Cockcroft-Gault formula).
    • bilirubin ≤ 1.5 x ULN (≤ 2.5 x ULN if secondary to Gilbert’s disease)
    • AST and ALT ≤ 3.0 x ULN
    8) If of child-bearing potential, willing to use contraceptive measures during and for 3 months after completion of therapy.
    9) willing to give written informed consent
    E.4Principal exclusion criteria
    1) A candidate for potential curative surgery or radiotherapy.
    2) Intravesical therapy within the last 3 months,
    3) Documented brain metastasis or carcinomatous meningitis, treated or untreated. NOTE: Brain imaging is not required unless the patient has symptoms or physical signs of CNS disease.
    4) Peripheral neuropathy ≥Grade 2.
    5) Known serious hypersensitivity to gemcitabine, cisplatin or carboplatin.
    6) Current serious, uncontrolled medical condition such as congestive heart failure, angina, hypertension, arrhythmia, diabetes mellitus, infection, etc. or any condition such as a psychiatric illness which in the opinion of the investigator would make the patient unacceptable for the protocol.
    7) Cerebrovascular accident, myocardial infarction or pulmonary embolus within 6 months of randomization.
    8) Active second malignancy (except non-melanomatous skin cancer): active secondary malignancy is defined as a current need for cancer therapy or a high possibility (>30%) of recurrence during the study.
    9) Pregnant or nursing (must have a negative serum or urine pregnancy test within 72 hours prior to randomization).
    10) Participating in a concurrent clinical trial of an experimental drug, vaccine or device. Participation in an observational study is allowed.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint for each patient is overall survival time.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint for each patient is overall survival time measured as time from the date of randomization to the date of death from any cause. For patients still alive at the time of analysis, overall survival time will be censored on the date of last contact.
    E.5.2Secondary end point(s)
    The secondary efficacy objectives include evaluating the following:
    • Best response to therapy (CR, PR, SD, PD) will be summarized by treatment arm. In addition, the number (%) of patients with an overall response (CR or PR) and with disease control (PR or CR or SD) will be reported. Duration of responses will also be summarized.
    • Progression-free survival time (PFS) will be summarized by treatment arm. PFS is defined as the time from randomization to the date of disease progression or death, whichever occurs first, before or after treatment discontinuation. For those still on study and those who remain alive and have not progressed after treatment discontinuation, PFS will be censored on the date of the last tumor assessment.
    • Serum Hsp27 levels, serum clusterin levels and CTC counts will be summarized by treatment arm.
    • Serum OGX-427 Cmax and trough levels will be summarized by treatment arm.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time from the date of randomization to the date of death from any cause or the date of last contact for alive patients.
    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) 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 Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    France
    Germany
    Italy
    Poland
    Spain
    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
    Last visit of the last subject (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 months7
    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 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.1.1.1In 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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 180
    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 the patients will receive the local standard of care for their condition 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 Decision2011-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-20
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