A Study for Treatment of Superficial Bladder Cancer Using OGX-427
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ClinicalTrials.gov Identifier: NCT00959868 |
Recruitment Status : Unknown
Verified February 2012 by Vancouver Coastal Health.
Recruitment status was: Recruiting
First Posted : August 17, 2009
Last Update Posted : February 13, 2012
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Tracking Information | ||||
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First Submitted Date ICMJE | August 13, 2009 | |||
First Posted Date ICMJE | August 17, 2009 | |||
Last Update Posted Date | February 13, 2012 | |||
Study Start Date ICMJE | July 2009 | |||
Estimated Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
To define the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of OGX-427 (Vorinostat) administered as an intravesical instillation. [ Time Frame: On each visit: Days 1, 3, 5 and 8 ] | |||
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
To determine the toxicity profile of OGX-427 when administered intravesically. To measure evidence of OGX-427 effect on expression of Hsp27. To determine the bladder PK and PD profile of OGX-427 after intravesical administration. [ Time Frame: On each visit: Days 1, 3, 5, and 8 (for PK and PD profile); Days 1, 3, 5, 8 and 38 (for Toxicity profile) ] | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study for Treatment of Superficial Bladder Cancer Using OGX-427 | |||
Official Title ICMJE | A Phase I Clinical Trial Assessing Intravesical Antisense Oligonucleotide Targeting Heat Shock Protein 27 for the Treatment of Superficial Bladder Cancer | |||
Brief Summary | This is a single centre, open label, phase I dose escalation trial using a modified accelerated titration design. Patients with superficial bladder tumour (Ta or T1) or CIS and candidates for transurethral resection or muscle invasive disease (>T2) and candidates for radical cystectomy will be enrolled. OGX-427 will be given neoadjuvantly over 8 days, followed by a transurethral resection (for superficial disease) or radical cystectomy (for muscle invasive disease). Baseline Hsp27 levels will be determined from pre-treatment cytological samples from bladder washings and tumour biopsies performed prior to therapy. Post-treatment PK and PD data will be determined from TUR (for Ta, T1 tumours) or radical cystectomy (for T2 tumours) specimens. A recommended phase II dose will be determined from the toxicity, tissue pK, and percentage of Hsp27 knockdown. Effects of treatment on Hsp27 client protein levels and apoptotic index will also be evaluated. Evaluation during protocol treatment will take place to assess toxicity. Assessments will occur on various visits as per Evaluation Schedule. Adverse event evaluation based on NCI CTCAEv3.0. For quality of life assessment during treatment, the EORTC QLC-BLS24 will be used before first treatment (day 1) and prior to surgery (TURBT or radical cystectomy). The Day 1 QOL assessment will serve as baseline. After removal from protocol treatment, all subjects will be followed for toxicity related to study drug for 30 days. After the study, subjects will be followed according to standard of care. Follow-up for tumour recurrence or superficial tumours will be assessed every three months by cystoscopic examination for two years, then every six months for the next two years, and then yearly thereafter. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Bladder Cancer | |||
Intervention ICMJE | Drug: OGX-427
OGX-427 drug product is in 25mg/mL injection in a mannitol-phosphate buffer solution packaged to deliver at least 8mL volume from a 10mL Type I, clear glass vial (ammonium sulfate treated) with Teflon coated bromobutyl rubber stopper and sealed with an aluminum, red, flip-off over seal. The drug product is aseptically compounded and sterilized via sterile filtration prior to aseptic filling.
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Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
36 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | Not Provided | |||
Estimated Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00959868 | |||
Other Study ID Numbers ICMJE | BL-01 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Alan I. So, MD, FRCSC, Vancouver Coastal Health | |||
Study Sponsor ICMJE | Vancouver Coastal Health | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Vancouver Coastal Health | |||
Verification Date | February 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |