SB939 in Treating Patients With Recurrent or Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT01075308
• Study type: Interventional
• Source: Canadian Cancer Trials Group
• Status: Completed
• Phase: Phase 2
• Start date: June 28, 2010
• Completion date: February 13, 2015