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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Infinity Pharmaceuticals, Inc.

Criteria

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