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

Completed · Phase 2

Conditions studied: Prostate Cancer, Prostatic Neoplasms, Cancer of the Prostate

In brief

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

Key facts

Study ID

NCT00564928

Run by

Infinity Pharmaceuticals, Inc.

People needed

19

Starts

2007-11-01

Expected to finish

2010-07-01

Last updated by the study team

2012-12-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• San Bernardino Urological Associates — San Bernardino, California, United States
• Stanford University Medical Center — Stanford, California, United States
• University of Colorado at Denver — Denver, Colorado, United States
• MCG Cancer Center — Augusta, Georgia, United States
• University of Chicago Hospitals — Chicago, Illinois, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• Parkland Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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