Prostate Cancer Clinical Trial
— IPI-504-04Official 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
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
Status | Completed |
Enrollment | 19 |
Est. completion date | July 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | MCG Cancer Center | Augusta | Georgia |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of Chicago Hospitals | Chicago | Illinois |
United States | Parkland Hospital | Dallas | Texas |
United States | University of Colorado at Denver | Denver | Colorado |
United States | Wayne State University | Detroit | Michigan |
United States | San Bernardino Urological Associates | San Bernardino | California |
United States | Stanford University Medical Center | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Infinity Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlate prior treatment status with clinical response as determined by PSA and radiologic response rate | 12 Weeks | No | |
Secondary | Assess the safety and tolerability of IPI-504 in patients with hormone resistant prostate cancer | 12 Weeks | Yes |
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