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