SB939 in Treating Patients With Recurrent or Metastatic Prostate Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of SB939 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer|
- PSA response [ Time Frame: each cycle ] [ Designated as safety issue: No ]Each patient will have PSA response calculated. Required at the end of every cycle.
- Progression-free survival [ Time Frame: end of study ] [ Designated as safety issue: No ]Used as an indicator of efficacy, patients with PSA response will have length of progression free survival calculated.
- Objective response rate [ Time Frame: every other cycle ] [ Designated as safety issue: No ]Patients with measurable disease will have objective response evaluated.
- Duration of response [ Time Frame: every other cycle ] [ Designated as safety issue: No ]Patients with objective response will have duration of response calculated as will be followed until progression/relapse
- Safety [ Time Frame: each cycle ] [ Designated as safety issue: Yes ]Toxicity and tolerability will be evaluated
- Change in circulating tumor cells during study compared to baseline [ Time Frame: each cycle ] [ Designated as safety issue: No ]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 [ Time Frame: each cycle ] [ Designated as safety issue: No ]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 [ Time Frame: end of study ] [ Designated as safety issue: No ]Two different systems will be used to count CTC. Results will be compared at the end of the study for accuracy.
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Drug: HDAC inhibitor SB939
- 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.
- 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.
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA - Cancer Centre for the Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Canada, Nova Scotia|
|QEII Health Sciences Center|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Kim N. Chi, MD||British Columbia Cancer Agency|
|Study Chair:||Bernhard Eigl, MD, FRCPC||Tom Baker Cancer Centre - Calgary|