Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-30 @ 5:17 PM
Study NCT ID:
NCT00747734
Status:
COMPLETED
Last Update Posted:
2011-04-20
First Post:
2008-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of MNRP1685A in Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'C574067', 'term': 'vesencumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'lastUpdateSubmitDate': '2011-04-18', 'studyFirstSubmitDate': '2008-09-04', 'studyFirstSubmitQcDate': '2008-09-04', 'lastUpdatePostDateStruct': {'date': '2011-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and nature of dose-limiting toxicities (DLTs)', 'timeFrame': 'Length of study'}], 'secondaryOutcomes': [{'measure': 'Total exposure (AUC)', 'timeFrame': 'Length of study'}, {'measure': 'Maximum and minimum serum concentrations', 'timeFrame': 'Length of study'}, {'measure': 'Clearance', 'timeFrame': 'Length of study'}, {'measure': 'Volume of distribution', 'timeFrame': 'Length of study'}]}, 'conditionsModule': {'keywords': ['Neuropilin-1', 'NRP1', 'anti-NRP1', 'anti-angiogenic'], 'conditions': ['Solid Cancers']}, 'descriptionModule': {'briefSummary': 'This is a Phase I, first-in-human, open-label, dose-escalation study of MNRP1685A administered by IV infusion every 3 weeks in patients with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable. This study will be conducted at up to three study centers in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Incurable, locally advanced, or metastatic solid malignancy that has progressed on, or failed to respond to, at least one prior regimen\n* Evaluable or measurable disease per RECIST (in certain circumstances, prostate or ovarian cancer patients with non-measurable disease)\n\nExclusion Criteria:\n\n* Inadequate hematologic or organ function\n* Anti-cancer therapy within 4 weeks prior to initiation of study treatment\n* Recent history of or current clinically significant gastrointestinal, cardiovascular or pulmonary disorders\n* Any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytics, or a filter of the inferior vena cava\n* Active infection or autoimmune disease\n* Known human immunodeficiency virus (HIV) infection\n* Pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT00747734', 'briefTitle': 'A Study of MNRP1685A in Patients With Locally Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of MNRP1685A, a Human IgG1 Antibody, Administered Intravenously in Patients With Locally Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'ANP4509g'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MNRP1685A', 'type': 'DRUG', 'description': 'Escalating intravenous dose'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rainer Brachmann, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Disclosures Group', 'oldOrganization': 'Genentech, Inc.'}}}}