NCT00564928

A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-resistant Prostate Cancer

A Phase 2 Open-Label Study to Investigate the Pharmacodynamics and Clinical Activity of IPI-504 in Patients With Castration-Resistant Prostate Cancer Stratified by Prior Chemotherapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Infinity Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine: * Anti-tumor activity of IPI-504 in 2 groups of subjects with hormone resistant prostate cancer. * Group A - subjects who have not previously received chemotherapy * Group B - sujects who have received prior chemotherapy or could not tolerate chemotherapy. * Clinical response will be determined by PSA and radiological response

Detailed description

IPI-504 is a novel, water-soluble analog of 17-AAG and a potent inhibitor of Hsp90. Hsp90's role in the cell is to control the proper folding, function, and viability of various "client" proteins. Many of these client proteins (such as AKT, Her-2, Bcr-Abl, PDGFR-α, and c-Kit) are oncoproteins or important cell signaling proteins. Inhibition of HSP-90 leads to the proteasomal degradation of these proteins. In patients with HRPC,there are several proteins that are important in the progression of HRPC, including AR, AKT and Her-2. All of these are client proteins of Hsp90 and in response to Hsp90 inhibition are degraded by their proteasome. Preclinical studies have shown that Hsp90 inhibition causes a dose dependent degradation of these client proteins and growth inhibition of prostate cancer in xenograft tumors.

Conditions

• Prostate Cancer
• Prostatic Neoplasms
• Cancer of the Prostate

Interventions

Type	Name	Description
DRUG	IPI-504	IPI-504 at 400mg/m2, IV, 2 times a week for 2 weeks with 10 days off treatment. Twenty-one (21) day cycle

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-03-01
• Completion: 2010-07-01
• First posted: 2007-11-29
• Last updated: 2012-12-11

Locations

10 sites across 1 country: United States