Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-28 @ 3:24 PM
Study NCT ID:
NCT00400361
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2006-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C558734', 'term': 'RG-1507 monoclonal antibody'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2006-11-15', 'studyFirstSubmitQcDate': '2006-11-15', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life', 'timeFrame': 'Throughout study'}], 'secondaryOutcomes': [{'measure': 'Tumor response', 'timeFrame': 'Event driven'}]}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'pmid': '33768488', 'type': 'DERIVED', 'citation': 'Xin Y, Xu F, Gao Y, Bhatt N, Chamberlain J, Sile S, Hammel S, Holt RJ, Ramanathan S. Pharmacokinetics and Exposure-Response Relationship of Teprotumumab, an Insulin-Like Growth Factor-1 Receptor-Blocking Antibody, in Thyroid Eye Disease. Clin Pharmacokinet. 2021 Aug;60(8):1029-1040. doi: 10.1007/s40262-021-01003-3. Epub 2021 Mar 26.'}]}, 'descriptionModule': {'briefSummary': "This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is \\<100 individuals."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* adult patients, \\>=18 years of age;\n* solid neoplasm, non-Hodgkin's lymphoma or Hodgkin's lymphoma;\n* metastatic or locally advanced disease, not curable by any currently available treatment.\n\nExclusion Criteria:\n\n* severe, uncontrolled systemic disease;\n* patients who require treatment with glucocorticoids or immunosuppressive treatment within last 6 months;\n* patients with diabetes mellitus."}, 'identificationModule': {'nctId': 'NCT00400361', 'briefTitle': 'A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Dose-escalation Study of R1507 in Patients With Advanced Solid Tumors.', 'orgStudyIdInfo': {'id': 'BO19373'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: RG1507']}], 'interventions': [{'name': 'RG1507', 'type': 'DRUG', 'description': 'Administered iv, either weekly or 3 weekly, at escalating doses (with a starting dose of 1mg/kg) (7 cohorts).', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}