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Study ID IPI-504-04
Investigator
William Oh, MD,   Dana-Farber Cancer Institute
Title A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-resistant Prostate Cancer
Conditions Prostate Cancer
Prostatic Neoplasms
Cancer of the Prostate
Interventions Drug: IPI-504
Phase Phase 2
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
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
Inclusion Criteria:
  • 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:
  • 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
Study Location N/A
Contact N/A
Information obtained from ClinicalTrials.gov, on 6/19/2013. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564928


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