A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-resistant Prostate Cancer
Trial ID or NCT#
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
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
- - Adenocarcinoma of the prostate - Resolution of acute toxic side effects of prior chemotherapy - Castration resistant disease despite ongoing chemical or surgical castration - ECOG 0-1 - PSA greater than or equal to 2 - Group A - - No Prior treatment for prostate cancer with cytotoxic chemotherapy (neoadjuvant, adjuvant treatment permitted if more than 2 years out) - Group B - Radiographic evidence of metastatic disease - Prior tx with docetaxel-minimum of 2 cycles with progression by RECIST or PSA or intolerant of tx - Maximum of 3 prior chemotherapies
- - Small cell carcinoma of the prostate - Treatment within 2 weeks with approved, investigational, or small molecule - Treatment within 4 weeks with biologic or external beam radiation - ANC <1,500 cells m3; Platelets <100,000 mm3; Hemoglobin <9.0g/dL - AST/ALT >2.5 ULN - Serum creatinine >3.0mg/dL - Active keratitis or keratoconjunctivitis - Previous treatment with 17-AAG, DMAG; or any other HSP-90 inhibitor - Baseline Qtc >450 mses
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