Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2026-01-06 @ 3:53 PM
Study NCT ID:
NCT00688766
Status:
TERMINATED
Last Update Posted:
2012-12-11
First Post:
2008-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) Following Failure of at Least Imatinib and Sunitinib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'Belgium', 'France', 'Germany', 'South Korea', 'Sweden', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C112765', 'term': 'tanespimycin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'whyStopped': 'Based on Independent Data Monitoring Committee (IDMC) recommendation.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'dispFirstSubmitDate': '2012-12-06', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-07', 'studyFirstSubmitDate': '2008-05-29', 'dispFirstSubmitQcDate': '2012-12-06', 'studyFirstSubmitQcDate': '2008-06-02', 'dispFirstPostDateStruct': {'date': '2012-12-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the progression free survival (PFS) in both study arms', 'timeFrame': 'Multiple timepoints'}], 'secondaryOutcomes': [{'measure': 'Compare the disease control rate (DCR) in both arms', 'timeFrame': 'Multiple timepoints'}, {'measure': 'Compare the time to progression (TTP) in both arms', 'timeFrame': 'Multiple timepoints'}, {'measure': 'Compare the overall survival (OS) in both arms', 'timeFrame': 'Continuous'}, {'measure': 'Evaluate the safety and tolerability of IPI-504 in this patient population', 'timeFrame': 'Signing of the informed consent to 30 days after discontinuation of drug'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['GIST', 'Metastatic and/or Unresectable Gastrointestinal Stromal'], 'conditions': ['Gastrointestinal Stromal Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.gistsupport.org', 'label': 'Gist Support International - Patient Advocacy Group'}, {'url': 'http://www.liferaftgroup.org', 'label': 'The Liferaft Group - Patient Advocacy Group'}]}, 'descriptionModule': {'briefSummary': 'IPI-504-06 is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of IPI-504 as compared to placebo in patients with metastatic and/or unresectable GIST following failure of at least imatinib and sunitinib.\n\nApproximately 195 patients will be randomized using a 2:1 ratio to receive either IPI-504 (N=130) or placebo (N=65). Upon unblinding, patients receiving either IPI-504 or placebo may receive IPI-504 in the open-label portion of the study if defined inclusion criteria are met.\n\nEarly and frequent imaging timepoints (Weeks 2, 5, 8, 14 and every 6 weeks thereafter) are incorporated into this study to capture progression events and limit patient exposure to ineffective agents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age at the time of study randomization.\n* Histologically confirmed metastatic and/or unresectable GIST.\n* Measurable disease on CT or MRI as defined by RECIST.\n* Documented radiographic progression or intolerance to imatinib and sunitinib.\n* Clinical failure of the most recent prior therapy for GIST. Note: There is no limit to the number of prior therapies a patient may have received.\n* Eastern Cooperative Oncology Group (ECOG) performance status: 0 or 1.\n* Hemoglobin ≥ 8.0 g/dL (80 g/L).\n* Absolute Neutrophil Count ≥ 1500/µL (1.5 x 109/L).\n* Platelets ≥ 100,000 /µL (100 x 109/L).\n* ALT and AST ≤ 2.5 x upper limit of normal (ULN), or ≤ 5.0 x ULN if considered secondary to liver metastases.\n* Alkaline phosphatase ≤ 2.5 x ULN, or ≤ 5.0 x ULN if considered secondary to liver metastases.\n* Serum bilirubin ≤ 1.5 x ULN.\n* PT and PTT ≤ 1.5 x ULN unless the patient is receiving warfarin. If the patient is receiving warfarin, the INR must be within therapeutic range.\n* Serum creatinine ≤ 1.5 x ULN.\n\nExclusion Criteria:\n\n* Previous administration of other known heat shock protein 90 (Hsp90) inhibitors.\n* Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease.\n* Initiation or discontinuation of concurrent medication that is a potent CYP3A inhibitor less than 2 weeks prior to administration of IPI-504 or placebo.\n* History of any of the following within the last 6 months: cardiac disease such as acute coronary syndrome or unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, cirrhotic liver disease, cerebrovascular accident, or any other significant co-morbid condition or disease which, in the judgment of the investigator, would place the patient at undue risk or interfere with the study.\n* Grade 3 or 4 hemorrhagic event within the last 6 months.\n* Known human immunodeficiency virus positivity.\n* Sinus bradycardia (resting heart rate \\< 50 bpm) secondary to intrinsic conduction system disease.\n* QTcF ≥ 470 milliseconds, or previous history of clinically significant QTc prolongation while taking other medications.\n* History of prior malignancies within the past 3 years other than non-melanomatous skin cancers that have been controlled, prostate cancer that has been treated and has not recurred, non-muscle-invasive bladder cancer, and carcinoma in situ of the cervix.\n* Active or recent history (within 3 months) of keratitis or keratoconjunctivitis confirmed by ophthalmology or optometry exam.\n* Presence of Left Bundle Branch Block, Right Bundle Branch Block plus left anterior hemiblock, bifascicular block, or 3rd degree heart block. This does not include patients with a history of these events with adequate control by pacemaker.\n* Known CNS metastases.\n* Women who are pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT00688766', 'briefTitle': 'Study Evaluating IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) Following Failure of at Least Imatinib and Sunitinib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Infinity Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Evaluating the Efficacy and Safety of IPI-504 in Patients With Metastatic and/or Unresectable GIST Following Failure of at Least Imatinib and Sunitinib', 'orgStudyIdInfo': {'id': 'IPI-504-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IPI-504', 'description': 'retaspimycin hydrochloride (IPI-504) plus best supportive care', 'interventionNames': ['Drug: retaspimycin hydrochloride (IPI-504)', 'Other: Best supportive care']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo plus best supportive care', 'interventionNames': ['Drug: placebo', 'Other: Best supportive care']}], 'interventions': [{'name': 'retaspimycin hydrochloride (IPI-504)', 'type': 'DRUG', 'description': 'IPI-504 is a novel small molecule inhibitor of heat shock protein 90 (Hsp90). Patients will receive 400 mg/m2 of IPI-504 as a 30-minute IV infusion twice weekly for 2 weeks followed by 1 week off.', 'armGroupLabels': ['IPI-504']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Patients will receive a 30-minute IV infusion twice weekly for 2 weeks followed by 1 week off.', 'armGroupLabels': ['Placebo']}, {'name': 'Best supportive care', 'type': 'OTHER', 'description': 'Best supportive care will be according to institutional standard, but will not include administration of systemic cancer-specific therapies including chemotherapies, biologic therapies, investigational therapies, TKIs (e.g., imatinib, sunitinib, nilotinib, dasatinib), or local therapies such as surgery, radiotherapy, or lesion ablative therapies.', 'armGroupLabels': ['IPI-504', 'Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pedro Santabarbara, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Infinity Pharmaceuticals, Inc.'}, {'name': 'George Demetri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dana-Farber Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Infinity Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MedImmune LLC', 'class': 'INDUSTRY'}, {'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}