SB939 in Treating Patients With Recurrent or Metastatic Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Drug: HDAC inhibitor SB939
- Registration Number
- NCT01075308
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
RATIONALE: SB939 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well SB939 works in treating patients with recurrent or metastatic prostate cancer.
- Detailed Description
OBJECTIVES:
Primary
* To determine the efficacy, as measured by PSA response and progression-free survival, of HDAC inhibitor SB939 in patients with recurrent or metastatic castration-resistant prostate cancer.
Secondary
* To determine the objective response and response duration in patients with measurable disease at baseline.
* To determine the tolerability and toxicity of this drug in these patients.
* To determine the number of circulating tumor cells at baseline and after 6 weeks (and 12 weeks if patient is still on study treatment).
* To explore potential molecular factors predictive of response by assessment of archival prostate tumor tissue.
* To explore ERG and PTEN expression on circulating tumor cells as a potential prognostic and predictive marker for response to this drug.
* To determine time to PSA and time to objective progression in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral HDAC Inhibitor SB939 once daily on days 1, 3, 5, 8, 10, 12, 15, 17, and 19. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically for correlative studies. Blood samples and Archival tumor tissue are analyzed for TMPRSS2-ERG fusion and PTEN deletion status by FISH; TMPRSS2-ERG fusion by RT-PCR; and for the number of circulating tumor cells.
After completion of study therapy, patients are followed up at 4 weeks and then every 3 months thereafter.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SB939 HDAC inhibitor SB939 SB939 given orally every other day 3 times a week (i.e. Monday /Wednesday /Friday, or Tuesday /Thursday / Saturday) for 3 consecutive weeks followed by one week off-dosing. A treatment cycle is 4 weeks (28 days).
- Primary Outcome Measures
Name Time Method Progression-free survival end of study Used as an indicator of efficacy, patients with PSA response will have length of progression free survival calculated.
PSA response each cycle Each patient will have PSA response calculated. Required at the end of every cycle.
- Secondary Outcome Measures
Name Time Method Change in circulating tumor cells during study compared to baseline each cycle Patients will have on study samples compared to baseline to look for chance in number of CTC.
Comparison of TMPRSS2-ERG fusion and PTEN deletion in circulating tumor cells each cycle samples will be taken and analyzed each cycle with a comparison made at end of study.
Comparison of two systems for counting circulating tumor cells end of study Two different systems will be used to count CTC. Results will be compared at the end of the study for accuracy.
Safety each cycle Toxicity and tolerability will be evaluated
Duration of response every other cycle Patients with objective response will have duration of response calculated as will be followed until progression/relapse
Objective response rate every other cycle Patients with measurable disease will have objective response evaluated.
Trial Locations
- Locations (7)
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
QEII Health Sciences Center
🇨🇦Halifax, Nova Scotia, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
BCCA - Cancer Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
Tom Baker Cancer Centre
🇨🇦Calgary, Alberta, Canada
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada