Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-02-03 @ 3:19 AM
Study NCT ID:
NCT02221505
Status:
TERMINATED
Last Update Posted:
2016-04-05
First Post:
2014-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of LOP628 in Adult Patients With cKit-positive Solid Tumors and Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Germany', 'Italy', 'United States']}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-02', 'studyFirstSubmitDate': '2014-08-08', 'studyFirstSubmitQcDate': '2014-08-19', 'lastUpdatePostDateStruct': {'date': '2016-04-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incident rate of dose limiting toxicities (DLTs)', 'timeFrame': 'Month 12', 'description': 'To estimate the maximum tolerated dose/recommended dose for expansion (MTD/RDE)'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events (AEs) and serious adverse events (SAE)', 'timeFrame': '30 months', 'description': 'Characterize the safety and tolerability of LOP628'}, {'measure': 'Severity of adverse events (AEs) and serious adverse events (SAEs)', 'timeFrame': '30 months', 'description': 'Characterize the safety and tolerability of LOP628'}, {'measure': 'Serum PK parameters (AUC, Cmax, Tmax, and half-life)', 'timeFrame': '30 months', 'description': 'To characterize the pharmacokinetic profile of LOP628'}, {'measure': 'Serum concentration vs. time profiles', 'timeFrame': '30 months', 'description': 'To characterize the pharmacokinetic profile of LOP628.'}, {'measure': 'Overall response rate (ORR)', 'timeFrame': '30 months', 'description': 'To assess the preliminary anti-tumor activity of LOP628'}, {'measure': 'Duration of response (DOR)', 'timeFrame': '30 months', 'description': 'To assess the preliminary anti-tumor activity of LOP628'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': '30 months', 'description': 'To assess the preliminary anti-tumor activity of LOP628'}, {'measure': 'Disease Control Rate (DCR) at 4 months', 'timeFrame': '4 months', 'description': 'To assess the preliminary anti-tumor activity of LOP628'}, {'measure': 'Best overall response (BOR)', 'timeFrame': '30 months', 'description': 'To assess the preliminary anti-tumor activity of LOP628 in patients'}, {'measure': 'Best Overall Response (AML)', 'timeFrame': '30 months', 'description': 'To assess the preliminary anti-tumor activity of LOP628'}, {'measure': 'Duration of response (DOR) (AML)', 'timeFrame': '30 months', 'description': 'To assess the preliminary anti-tumor activity of LOP628'}, {'measure': 'Event Free Survival (EFS) (AML)', 'timeFrame': '30 months', 'description': 'To assess the preliminary anti-tumor activity of LOP628'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['LOP628,', 'cKit,', 'ADC,', 'Antibody drug conjugates,', 'maytansine'], 'conditions': ['cKIT-positive Solid Tumors', 'AML']}, 'descriptionModule': {'briefSummary': 'LOP628 is an antibody-drug conjugate (ADC) consisting of an anti-cKit humanized IgG1/κ antibody conjugated to a maytansine payload via a non-cleavable linker.\n\nLOP628 provides an opportunity to target cKit overexpressing tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor patients with solid tumors:\n\n* documented cKit-positive neoplasms\n* Patient must have progressive disease as defined by any of the following:\n* SCLC: patient has progressed after at least 1 prior therapy\n* GIST : patient has relapsed or has refractory disease, and no further approved effective therapeutic option exists\n* Patients with other cKit-positive solid tumors: patient has progressed after at least one prior line of therapy and no further approved effective therapeutic option exists\n* Patient has measurable disease as per RECIST v1.1 criteria\n\nFor patients with AML:\n\n* documented cKit-positive acute myelogenous leukemia\n* Consent to newly obtained bone marrow aspirate\n* Patient must have progressive disease defined as relapsed or refractory non-PML AML following standard therapy or for whom no effective therapy exists.\n* Blast count \\< 50,000/mm3\n\nExclusion Criteria:\n\nFor patients with solid tumors:\n\n* Patient has central nervous system (CNS) metastatic involvement unless the CNS metastases have been previously treated and the patient is clinically stable and on a stable dose of corticosteroids for at least 4 weeks prior to enrollment.\n* Patient has the presence of other clinically significant hematologic, cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.\n* Patient has a history of serious allergic reactions, which in the opinion of the investigator may pose an increased risk of serious infusion reactions\n* Patient has been previously treated with cKit directed antibodies\n* Pregnant or nursing women\n\nFor patients with AML:\n\n* Patient has received prior allogeneic bone marrow transplant (BMT).\n* Patient has the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease\n* Patient has a history of serious allergic reactions, which in the opinion of the investigator may pose an increased risk of serious infusion reactions\n* Patient has been previously treated with cKit directed antibodies\n* Pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT02221505', 'briefTitle': 'Phase 1 Study of LOP628 in Adult Patients With cKit-positive Solid Tumors and Acute Myeloid Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase I, Multicenter, Open-label Dose Escalation and Expansion Study of LOP628, Administered Intravenously in Adult Patients With cKit-positive Tumors and Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'CLOP628X2101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LOP628 - Solid Tumor', 'description': 'with LOP628', 'interventionNames': ['Drug: LOP628']}, {'type': 'EXPERIMENTAL', 'label': 'LOP628 - AML', 'description': 'With LOP628', 'interventionNames': ['Drug: LOP628']}, {'type': 'EXPERIMENTAL', 'label': 'LOP628 - Solid Tumor Expansion', 'description': 'With LOP628', 'interventionNames': ['Drug: LOP628']}], 'interventions': [{'name': 'LOP628', 'type': 'DRUG', 'armGroupLabels': ['LOP628 - AML', 'LOP628 - Solid Tumor', 'LOP628 - Solid Tumor Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2300 RC', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}