Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2026-03-12 @ 1:33 PM
Study NCT ID:
NCT00564928
Status:
COMPLETED
Last Update Posted:
2012-12-11
First Post:
2007-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C112765', 'term': 'tanespimycin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'dispFirstSubmitDate': '2012-12-06', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-07', 'studyFirstSubmitDate': '2007-11-27', 'dispFirstSubmitQcDate': '2012-12-06', 'studyFirstSubmitQcDate': '2007-11-28', 'dispFirstPostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlate prior treatment status with clinical response as determined by PSA and radiologic response rate', 'timeFrame': '12 Weeks'}], 'secondaryOutcomes': [{'measure': 'Assess the safety and tolerability of IPI-504 in patients with hormone resistant prostate cancer', 'timeFrame': '12 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hormone resistant prostate cancer', 'castrate resistant prostate cancer', 'HRPC', 'CRPC'], 'conditions': ['Prostate Cancer', 'Prostatic Neoplasms', 'Cancer of the Prostate']}, 'descriptionModule': {'briefSummary': 'To determine:\n\n* Anti-tumor activity of IPI-504 in 2 groups of subjects with hormone resistant prostate cancer.\n* Group A - subjects who have not previously received chemotherapy\n* Group B - sujects who have received prior chemotherapy or could not tolerate chemotherapy.\n* Clinical response will be determined by PSA and radiological response', 'detailedDescription': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adenocarcinoma of the prostate\n* Resolution of acute toxic side effects of prior chemotherapy\n* Castration resistant disease despite ongoing chemical or surgical castration\n* ECOG 0-1\n* PSA greater than or equal to 2\n* Group A -\n\n * No Prior treatment for prostate cancer with cytotoxic chemotherapy (neoadjuvant, adjuvant treatment permitted if more than 2 years out)\n* Group B\n\n * Radiographic evidence of metastatic disease\n * Prior tx with docetaxel-minimum of 2 cycles with progression by RECIST or PSA or intolerant of tx\n * Maximum of 3 prior chemotherapies\n\nExclusion Criteria:\n\n* Small cell carcinoma of the prostate\n* Treatment within 2 weeks with approved, investigational, or small molecule\n* Treatment within 4 weeks with biologic or external beam radiation\n* ANC \\<1,500 cells m3; Platelets \\<100,000 mm3; Hemoglobin \\<9.0g/dL\n* AST/ALT \\>2.5 ULN\n* Serum creatinine \\>3.0mg/dL\n* Active keratitis or keratoconjunctivitis\n* Previous treatment with 17-AAG, DMAG; or any other HSP-90 inhibitor\n* Baseline Qtc \\>450 mses'}, 'identificationModule': {'nctId': 'NCT00564928', 'acronym': 'IPI-504-04', 'briefTitle': 'A Phase 2 Study to Investigate the Clinical Activity of IPI-504 in Patients With Hormone-resistant Prostate Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Infinity Pharmaceuticals, Inc.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'IPI-504-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IPI-504: Group A', 'description': 'No Prior treatment for prostate cancer with cytotoxic chemotherapy (adjuvant or neoadjuvant chemotherapy is acceptable if completed \\>2 years prior to study)', 'interventionNames': ['Drug: IPI-504']}, {'type': 'EXPERIMENTAL', 'label': 'IPI-504: Group B', 'description': '* Must have evidence of radiographic metastatic disease\n* 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\n* No more than three prior chemotherapies regimens for HRPC', 'interventionNames': ['Drug: IPI-504']}], 'interventions': [{'name': 'IPI-504', 'type': 'DRUG', 'description': 'IPI-504 at 400mg/m2, IV, 2 times a week for 2 weeks with 10 days off treatment. Twenty-one (21) day cycle', 'armGroupLabels': ['IPI-504: Group A', 'IPI-504: Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92404', 'city': 'San Bernardino', 'state': 'California', 'country': 'United States', 'facility': 'San Bernardino Urological Associates', 'geoPoint': {'lat': 34.10834, 'lon': -117.28977}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado at Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'MCG Cancer Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Hospitals', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'William Oh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Infinity Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}