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A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-resistant Prostate Cancer (IPI-504-04)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00564928
First received: November 27, 2007
Last updated: December 7, 2012
Last verified: December 2012
History of Changes
  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

Condition Intervention Phase
Prostate Cancer
Prostatic Neoplasms
Cancer of the Prostate
 Drug: IPI-504
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Infinity Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Correlate prior treatment status with clinical response as determined by PSA and radiologic response rate [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the safety and tolerability of IPI-504 in patients with hormone resistant prostate cancer [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 19
Study Start Date: November 2007
Study Completion Date: July 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IPI-504: Group A
No Prior treatment for prostate cancer with cytotoxic chemotherapy (adjuvant or neoadjuvant chemotherapy is acceptable if completed >2 years prior to study)
 Drug: IPI-504
IPI-504 at 400mg/m2, IV, 2 times a week for 2 weeks with 10 days off treatment. Twenty-one (21) day cycle
Experimental: IPI-504: Group B
  • Must have evidence of radiographic metastatic disease
  • Must have been treated with a docetaxel-based chemotherapy regimen for HRPC with a minimum of 2 cycles with either PSA or RECIST defined radiographic progression during or witin 60 days of completeing docetaxel based chemotheraph or be intolerant of docetaxel-based chemotherapy
  • No more than three prior chemotherapies regimens for HRPC
 Drug: IPI-504
IPI-504 at 400mg/m2, IV, 2 times a week for 2 weeks with 10 days off treatment. Twenty-one (21) day cycle

Detailed Description:

IPI-504 is a novel, water-soluble analog of 17-AAG and a potent inhibitor of Hsp90. Hsp90's role in the cell is to control the proper folding, function, and viability of various "client" proteins. Many of these client proteins (such as AKT, Her-2, Bcr-Abl, PDGFR-α, and c-Kit) are oncoproteins or important cell signaling proteins. Inhibition of HSP-90 leads to the proteasomal degradation of these proteins.

In patients with HRPC,there are several proteins that are important in the progression of HRPC, including AR, AKT and Her-2. All of these are client proteins of Hsp90 and in response to Hsp90 inhibition are degraded by their proteasome. Preclinical studies have shown that Hsp90 inhibition causes a dose dependent degradation of these client proteins and growth inhibition of prostate cancer in xenograft tumors.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564928

Locations
United States, California
San Bernardino Urological Associates
San Bernardino, California, United States, 92404
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
University of Colorado at Denver
Denver, Colorado, United States, 80045
United States, Georgia
MCG Cancer Center
Augusta, Georgia, United States, 30912
United States, Illinois
University of Chicago Hospitals
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Texas
Parkland Hospital
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Infinity Pharmaceuticals, Inc.
Investigators
Principal Investigator: William Oh, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Infinity Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00564928     History of Changes
Other Study ID Numbers: IPI-504-04
Study First Received: November 27, 2007
Last Updated: December 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Infinity Pharmaceuticals, Inc.:
Hormone resistant prostate cancer
castrate resistant prostate cancer
HRPC
CRPC

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013