A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-Resistant Prostate Cancer - Full Text View

Sponsored by:	Infinity Pharmaceuticals
Information provided by:	Infinity Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00564928

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 II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: IPI-504 17-(Allylamino)-17-demethoxygeldanamycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Infinity Pharmaceuticals:

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 ]

Estimated Enrollment:	50
Study Start Date:	November 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental 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
Group B: Experimental 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 thatn 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

Arms

Assigned Interventions

Group A: Experimental

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

Group B: Experimental

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 thatn 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 of 0 or 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

Investigators

Principal Investigator:

William Oh, MD

Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute ( Dr. William Oh )
Study ID Numbers:	IPI-504-04
Study First Received:	November 27, 2007
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00564928
Health Authority:	United States: Food and Drug Administration

Keywords provided by Infinity Pharmaceuticals:

Hormone resistant prostate cancer
castrate resistant prostate cancer
HRPC
CRPC

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009