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A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-resistant Prostate Cancer
Not Recruiting
Trial ID: NCT00564928
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
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
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
Intervention(s):
drug: IPI-504
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Denise Haas
6507361252