NCT01075308

SB939 in Treating Patients With Recurrent or Metastatic Prostate Cancer

A Phase II Study of SB939 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	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).

Timeline

• Start date: 2010-06-28
• Primary completion: 2015-01-05
• Completion: 2015-02-13
• First posted: 2010-02-25
• Last updated: 2023-08-04

Locations

7 sites across 1 country: Canada