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

Trial ID or NCT#

NCT00564928

Status

not recruiting iconNOT RECRUITING

Purpose

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

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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
Exclusion Criteria:
  1. - 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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Investigator(s)

Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

Contact us to find out if this trial is right for you.

Contact

Denise Haas
(650) 736-1252

View on ClinicalTrials.gov