Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-30 @ 10:24 AM
Study NCT ID:
NCT02678260
Status:
COMPLETED
Last Update Posted:
2018-06-08
First Post:
2016-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study of PDR001 in Patients With Advanced Malignancies.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711728', 'term': 'spartalizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-06', 'studyFirstSubmitDate': '2016-01-21', 'studyFirstSubmitQcDate': '2016-02-04', 'lastUpdatePostDateStruct': {'date': '2018-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose limiting toxicities (DLTs)', 'timeFrame': '28 days', 'description': 'cycle = 28 days'}], 'secondaryOutcomes': [{'measure': 'PK parameter: AUC', 'timeFrame': 'Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)', 'description': 'To characterize the PK profile of PDR001; cycle = 28 days'}, {'measure': 'Serum concentration vs. time profiles', 'timeFrame': 'C1D1, C3D1', 'description': 'Serum concentration of PDR001 at the scheduled timepoints up to 336 hours after administration'}, {'measure': 'Presence and/or concentration of anti-PDR001 antibodies', 'timeFrame': 'Day 1 on from C1 to C6', 'description': 'To assess the emergence of anti-PDR001 antibodies following one or more intravenous infusions of PDR001.'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)', 'description': 'cycle = 28 days'}, {'measure': 'Duration of response rate (DOR)', 'timeFrame': 'up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)', 'description': 'cycle = 28 days'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'up to cycle 11; every 2 cycles (8 weeks), after cycle 12; every 3 cycles (12 weeks)', 'description': 'cycle = 28 days'}, {'measure': 'PK parameter: Cmax', 'timeFrame': 'Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)', 'description': 'To characterize the PK profile of PDR001; cycle = 28 days'}, {'measure': 'PK parameter: Tmax', 'timeFrame': 'Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)', 'description': 'To characterize the PK profile of PDR001; cycle = 28 days'}, {'measure': 'PK parameter: half-life', 'timeFrame': 'Cycle 1 Day 1 (C1D1), Cycle 3 Day 1 (C3D1)', 'description': 'To characterize the PK profile of PDR001; cycle = 28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced malignancies', 'PDR001', 'Japanese patients', 'adults'], 'conditions': ['Advanced Malignancies']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the safety, tolerability, Pharmacokinetics (PK), and antitumor activity of PDR001 administered intravenous (i.v.) as a single agent to Japanese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with advanced/metastatic solid tumors, with measurable or non-measurable disease as determined by response evaluation criteria in solid tumors (RECIST) version 1.1, who have progressed despite standard therapy or are intolerant of standard therapy, or for whom no standard therapy exists\n* ECOG Performance Status ≤ 2\n\nExclusion Criteria:\n\n* Active autoimmune disease\n* Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n* Prior PD-1- or PD-L1-directed therapy\n\nOther protocol defined inclusion/exclusion may apply.'}, 'identificationModule': {'nctId': 'NCT02678260', 'briefTitle': 'Phase I Study of PDR001 in Patients With Advanced Malignancies.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase-I Study of PDR001 Administered to Japanese Patients With Advanced Malignancies', 'orgStudyIdInfo': {'id': 'CPDR001X1101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PDR001', 'description': 'PDR001 will be administered i.v. every two weeks until a patient experiences unacceptable toxicity, progressive disease as per irRC and/or treatment is discontinued at the discretion of the investigator or the patient. The treatment period will begin on Cycle 1 Day 1. For the purpose of scheduling and evaluations, a treatment cycle will consist of 28 days. During the study, cohorts of patients will be treated with PDR001 until the maximum tolerated dose (MTD) is reached or a lower recommended dose (RD) is established.', 'interventionNames': ['Drug: PDR001']}], 'interventions': [{'name': 'PDR001', 'type': 'DRUG', 'description': 'PDR001 is a high-affinity, ligand-blocking, humanized anti-PD-1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2 to PD-1.', 'armGroupLabels': ['PDR001']}]}, 'contactsLocationsModule': {'locations': [{'zip': '466-8560', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '277-8577', 'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'zip': '650-0017', 'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}