A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-resistant Prostate Cancer
NCT ID: NCT00564928
Last Updated: 2012-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
19 participants
INTERVENTIONAL
2007-11-30
2010-07-31
Brief Summary
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* 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
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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)
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
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Infinity Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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William Oh, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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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
Countries
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Other Identifiers
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IPI-504-04
Identifier Type: -
Identifier Source: org_study_id