Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-31 @ 6:33 AM
Study NCT ID:
NCT01358903
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of RO5429083 in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-05-18', 'studyFirstSubmitQcDate': '2011-05-20', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Arm A: Safety (Incidence of adverse events related to study drug)', 'timeFrame': 'Until disease progression or unacceptable toxicity (approximately 2 years)'}, {'measure': 'Arm A: Maximum tolerated dose of RO5429083', 'timeFrame': 'Until disease progression or unacceptable toxicity (approximately 2 years)'}, {'measure': 'Arm A: Tumor Growth Control Rate', 'timeFrame': 'Until disease progression or unacceptable toxicity (approximately 2 years)'}, {'measure': 'Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET)', 'timeFrame': 'Until disease progression or unacceptable toxicity (approximately 2 years)'}, {'measure': 'Arm A: Pharmacokinetics (serum levels of RO5429083)', 'timeFrame': 'Until disease progression or unacceptable toxicity (approximately 2 years)'}], 'secondaryOutcomes': [{'measure': 'Arm A: Recommended dose of RO5429083 for the extension cohort', 'timeFrame': 'Until disease progression or unacceptable toxicity (approximately 2 years)'}, {'measure': 'Arm A: Anti-tumor activity of RO5429083', 'timeFrame': 'Until disease progression or unacceptable toxicity (approximately 2 years)'}, {'measure': 'Arm B: Target saturation of 89Zr-labelled RO5429083', 'timeFrame': 'Until disease progression or unacceptable toxicity (approximately 2 years)'}]}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1 and/or 2, followed by RO5429083. For all patients there will be an option to continue treatment with RO5429083 until disease progression or unacceptable toxicity occurs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/= 18 years of age\n* Metastatic and/or locally advanced malignant CD44-expressing solid tumors\n* Patients with disease progression on standard therapy, or have tumors that are not curable by standard therapy\n* Life expectancy of over 12 weeks\n\nExclusion Criteria:\n\n* Concurrent therapy with any other investigational drug\n* Known or suspected CNS metastases including leptomeningeal metastases\n* Active bleeding, bleeding diathesis or history of coagulation disorder\n* Uncontrolled diabetes mellitus\n* Active or uncontrolled infections\n* Patients with HIV infections'}, 'identificationModule': {'nctId': 'NCT01358903', 'briefTitle': 'A Study of RO5429083 in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Open-Label Multicenter 2-Arm Phase I Study of RO5429083 With Dose-Escalation and Extension Cohorts, and Imaging Cohorts With RO5429083 and 89Zr-labeled RO5429083, in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors', 'orgStudyIdInfo': {'id': 'BP25385'}, 'secondaryIdInfos': [{'id': '2010-021168-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: RO5429083']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: RO5429083']}], 'interventions': [{'name': 'RO5429083', 'type': 'DRUG', 'description': 'Cohorts receiving multiple escalating doses iv', 'armGroupLabels': ['A']}, {'name': 'RO5429083', 'type': 'DRUG', 'description': 'Cohorts receiving 89Zr-labelled RO5429083 plus RO5429083, followed by RO5429083 until disease progression', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '75231', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}