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
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

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