A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-resistant Prostate Cancer — IPI-504-04  

Prostate Cancer Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer of the Prostate
• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00564928
• Study type: Interventional
• Source: Infinity Pharmaceuticals, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: November 2007
• Completion date: July 2010