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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)

Primary Purpose

Prostate Cancer, Prostatic Neoplasms, Cancer of the Prostate

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
IPI-504
Sponsored by
Infinity Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Hormone resistant prostate cancer, castrate resistant prostate cancer, HRPC, CRPC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • San Bernardino Urological Associates
  • Stanford University Medical Center
  • University of Colorado at Denver
  • MCG Cancer Center
  • University of Chicago Hospitals
  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Wayne State University
  • Parkland Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IPI-504: Group A

IPI-504: Group B

Arm Description

No Prior treatment for prostate cancer with cytotoxic chemotherapy (adjuvant or neoadjuvant chemotherapy is acceptable if completed >2 years prior to study)

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

Outcomes

Primary Outcome Measures

Correlate prior treatment status with clinical response as determined by PSA and radiologic response rate

Secondary Outcome Measures

Assess the safety and tolerability of IPI-504 in patients with hormone resistant prostate cancer

Full Information

First Posted
November 27, 2007
Last Updated
December 7, 2012
Sponsor
Infinity Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00564928
Brief Title
A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-resistant Prostate Cancer
Acronym
IPI-504-04
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Infinity Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostatic Neoplasms, Cancer of the Prostate
Keywords
Hormone resistant prostate cancer, castrate resistant prostate cancer, HRPC, CRPC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IPI-504: Group A
Arm Type
Experimental
Arm Description
No Prior treatment for prostate cancer with cytotoxic chemotherapy (adjuvant or neoadjuvant chemotherapy is acceptable if completed >2 years prior to study)
Arm Title
IPI-504: Group B
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
IPI-504
Intervention Description
IPI-504 at 400mg/m2, IV, 2 times a week for 2 weeks with 10 days off treatment. Twenty-one (21) day cycle
Primary Outcome Measure Information:
Title
Correlate prior treatment status with clinical response as determined by PSA and radiologic response rate
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Assess the safety and tolerability of IPI-504 in patients with hormone resistant prostate cancer
Time Frame
12 Weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Oh, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Bernardino Urological Associates
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado at Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
MCG Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
University of Chicago Hospitals
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Parkland Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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