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

December 7, 2012 updated by: Infinity Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Bernardino, California, United States, 92404
        • San Bernardino Urological Associates
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Colorado
      • Denver, Colorado, United States, 80045
        • University of Colorado at Denver
    • Georgia
      • Augusta, Georgia, United States, 30912
        • MCG Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospitals
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Texas
      • Dallas, Texas, United States, 75390
        • Parkland Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlate prior treatment status with clinical response as determined by PSA and radiologic response rate
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess the safety and tolerability of IPI-504 in patients with hormone resistant prostate cancer
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Infinity Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: William Oh, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

November 27, 2007

First Submitted That Met QC Criteria

November 28, 2007

First Posted (Estimate)

November 29, 2007

Study Record Updates

Last Update Posted (Estimate)

December 11, 2012

Last Update Submitted That Met QC Criteria

December 7, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPI-504-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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