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

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Contact

Denise Haas
6507361252

View on ClinicalTrials.gov