Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-26 @ 1:40 AM
Study NCT ID:
NCT01164033
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2010-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of RO5045337 in Patients With 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2010-07-15', 'studyFirstSubmitQcDate': '2010-07-15', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Examination of potential food-effect on pharmacokinetics of RO5045337', 'timeFrame': '3 weeks'}, {'measure': 'Evaluation of relative bioavailability of RO5045337', 'timeFrame': '3 weeks'}], 'secondaryOutcomes': [{'measure': 'Evaluation of safety and tolerability of RO5045337', 'timeFrame': '3 weeks'}, {'measure': 'Evaluation of pharmacodynamics and biomarkers', 'timeFrame': '3 weeks'}]}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'pmid': '26210682', 'type': 'DERIVED', 'citation': 'Patnaik A, Tolcher A, Beeram M, Nemunaitis J, Weiss GJ, Bhalla K, Agrawal M, Nichols G, Middleton S, Beryozkina A, Sarapa N, Peck R, Zhi J. Clinical pharmacology characterization of RG7112, an MDM2 antagonist, in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Sep;76(3):587-95. doi: 10.1007/s00280-015-2830-8. Epub 2015 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'This open-label, randomized, cross-over study will evaluate the effect of food on the pharmacokinetics of single oral doses of RO5045337 in patients with solid tumors. The anticipated time on study treatment is 3 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, \\>/=18 years of age\n* Histologically confirmed solid tumor\n* Life expectancy of \\>/=12 weeks\n* ECOG performance status of 0 or 1\n* Adequate bone marrow, renal and hepatic function\n\nExclusion Criteria:\n\n* Patients receiving any other investigational agent or therapy administered with the intention to treat their malignancy within 28 days prior to study start\n* Patients with pre-existing gastro-intestinal disorder\n* Patients with uncontrolled intercurrent illness'}, 'identificationModule': {'nctId': 'NCT01164033', 'briefTitle': 'A Study of RO5045337 in Patients With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open-Label, Randomized 3-Way Crossover, Study to Examine the Food-Effect on Pharmacokinetics of the Current Formulation and Relative Bioavailability of Two New Formulations for RO5045337 in Patients With Solid Tumors Including Lymphoma', 'orgStudyIdInfo': {'id': 'NP25299'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Drug: RO5045337']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: RO5045337']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'interventionNames': ['Drug: RO5045337']}, {'type': 'EXPERIMENTAL', 'label': 'D', 'interventionNames': ['Drug: RO5045337']}], 'interventions': [{'name': 'RO5045337', 'type': 'DRUG', 'description': 'single oral dose', 'armGroupLabels': ['A', 'B', 'C', 'D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '66160-7330', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '20895', 'city': 'Kensignton', 'state': 'Maryland', 'country': 'United States'}, {'zip': '75230', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}