Trial Search Results

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

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Infinity Pharmaceuticals, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: IPI-504

Phase:

Phase 2

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Denise Haas
6507361252
Not Recruiting