Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-28 @ 6:44 PM
Study NCT ID:
NCT01476657
Status:
TERMINATED
Last Update Posted:
2021-03-17
First Post:
2011-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C586691', 'term': 'duvelisib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'whyStopped': 'The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2011-11-17', 'studyFirstSubmitQcDate': '2011-11-17', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability', 'timeFrame': 'At least 28 days (1 Cycle)', 'description': 'To determine the incidence of adverse events and abnormal laboratory test results, including dose-limiting toxicities.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase 1'], 'conditions': ['Hematologic Malignancies']}, 'referencesModule': {'references': [{'pmid': '29233821', 'type': 'DERIVED', 'citation': 'Horwitz SM, Koch R, Porcu P, Oki Y, Moskowitz A, Perez M, Myskowski P, Officer A, Jaffe JD, Morrow SN, Allen K, Douglas M, Stern H, Sweeney J, Kelly P, Kelly V, Aster JC, Weaver D, Foss FM, Weinstock DM. Activity of the PI3K-delta,gamma inhibitor duvelisib in a phase 1 trial and preclinical models of T-cell lymphoma. Blood. 2018 Feb 22;131(8):888-898. doi: 10.1182/blood-2017-08-802470. Epub 2017 Dec 12.'}, {'pmid': '29191916', 'type': 'DERIVED', 'citation': "Flinn IW, O'Brien S, Kahl B, Patel M, Oki Y, Foss FF, Porcu P, Jones J, Burger JA, Jain N, Kelly VM, Allen K, Douglas M, Sweeney J, Kelly P, Horwitz S. Duvelisib, a novel oral dual inhibitor of PI3K-delta,gamma, is clinically active in advanced hematologic malignancies. Blood. 2018 Feb 22;131(8):877-887. doi: 10.1182/blood-2017-05-786566. Epub 2017 Nov 30."}, {'pmid': '28017967', 'type': 'DERIVED', 'citation': "Patel VM, Balakrishnan K, Douglas M, Tibbitts T, Xu EY, Kutok JL, Ayers M, Sarkar A, Guerrieri R, Wierda WG, O'Brien S, Jain N, Stern HM, Gandhi V. Duvelisib treatment is associated with altered expression of apoptotic regulators that helps in sensitization of chronic lymphocytic leukemia cells to venetoclax (ABT-199). Leukemia. 2017 Sep;31(9):1872-1881. doi: 10.1038/leu.2016.382. Epub 2016 Dec 26."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety, maximum tolerated dose and pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years of age;\n* Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease with no established therapy with the exception of expansion cohort of treatment naïve CLL patients;\n* An Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.\n\nExclusion Criteria:\n\n* Any previous treatment with a PI3K inhibitor (Escalation Phase only) or within 4 weeks of the start of IPI-145 administration (Expansion Phase);\n* Patients with overt leptomeningeal leukemia or CNS lymphoma;\n* Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \\> 2.5 x upper limit of normal (ULN); direct bilirubin \\>1.5 x ULN;\n* Inadequate renal function defined by serum creatinine \\> 1.5 x ULN'}, 'identificationModule': {'nctId': 'NCT01476657', 'briefTitle': 'A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'SecuraBio'}, 'officialTitle': 'A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies', 'orgStudyIdInfo': {'id': 'IPI-145-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IPI-145', 'description': 'IPI-145 is administered orally as a capsule formulation. The IPI-145 drug product is supplied as 1 mg, 5 mg, 25 mg, and 100 mg formulated capsules. IPI-145 will be administered orally daily during each 28-day cycle. Patients will be evaluated for DLTs in the dose escalation portion of the study during Cycle 1 (28 days), after which treatment may continue for additional cycles.', 'interventionNames': ['Drug: IPI-145 (duvelisib)']}], 'interventions': [{'name': 'IPI-145 (duvelisib)', 'type': 'DRUG', 'description': 'Oral Twice A Day (BID) Dosing', 'armGroupLabels': ['IPI-145']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Hagop Youssoufian, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Verastem, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SecuraBio', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}