Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT01086267
Status:
COMPLETED
Last Update Posted:
2016-06-27
First Post:
2010-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of BMS-908662 Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000593770', 'term': 'BMS 908662'}, {'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'dispFirstSubmitDate': '2015-09-23', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-23', 'studyFirstSubmitDate': '2010-03-11', 'dispFirstSubmitQcDate': '2015-09-23', 'studyFirstSubmitQcDate': '2010-03-11', 'dispFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity will be evaluated according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 3', 'timeFrame': 'Assessments every 1-2 weeks while receiving study drug'}], 'secondaryOutcomes': [{'measure': 'Efficacy as determined by estimates of objective response rates and response duration', 'timeFrame': 'Efficacy measured at least every 8 weeks while receiving study drug'}, {'measure': 'Pharmacodynamics (PD) will be assessed by evaluating markers of RAS/RAF pathway activity', 'timeFrame': 'PD assessed during the first 4 weeks on study'}, {'measure': 'Pharmacokinetics (PK) for BMS-908662 as determined by minimum observed concentrations [Cmin].', 'timeFrame': 'PK measured during first 4 weeks on study'}, {'measure': 'Pharmacokinetics (PK) for BMS-908662 as determined by maximum observed concentrations [Cmax].', 'timeFrame': 'PK measured during first 4 weeks on study'}, {'measure': 'Pharmacokinetics (PK) for BMS-908662 as determined by time of maximum observed concentration [Tmax].', 'timeFrame': 'PK measured during first 4 weeks on study'}, {'measure': 'Pharmacokinetics (PK) for BMS-908662 as determined by area under the concentration-curve for one dosing interval [AUC(TAU)].', 'timeFrame': 'PK measured during first 4 weeks on study'}, {'measure': 'Pharmacokinetics (PK) for BMS-908662 as determined by accumulation index [AI].', 'timeFrame': 'PK measured during first 4 weeks on study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to identify a safe and tolerable dose of BMS-908662 in combination with cetuximab; and then to evaluate the tumor response to BMS-908662 when administered alone or in combination with cetuximab', 'detailedDescription': 'Phase 1: Single Arm Study\n\nPhase 2: Randomized Controlled, Parallel'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with K-RAS (codon 12 or 13) or B -RAF (V600E) mutation positive advanced or metastatic colorectal cancer who have relapsed or are refractory to 2 or more standard systemic anticancer regimes for metastatic disease, or are intolerant to existing therapies.\n* Histologic or cytologic confirmation of the diagnosis.\n* Eastern Cooperative Oncology Group (ECOG) ≤ 1\n* Adequate organ \\& marrow function.\n\nExclusion Criteria:\n\n* Uncontrolled or significant cardiovascular disease.\n* Phase 2: Prior therapy with a RAF inhibitor.'}, 'identificationModule': {'nctId': 'NCT01086267', 'briefTitle': 'Safety and Efficacy Study of BMS-908662 Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1/2 Study of BMS-908662 (XL281) Alone or in Combination With Cetuximab in Subjects With K-RAS or B-RAF Mutation Positive Advanced or Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'CA206-001'}, 'secondaryIdInfos': [{'id': '2010-018944-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-908662 (A1)', 'description': 'Phase 1', 'interventionNames': ['Drug: BMS-908662']}, {'type': 'EXPERIMENTAL', 'label': 'Cetuximab (A1)', 'description': 'Phase 1', 'interventionNames': ['Drug: Cetuximab']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-908662 (B1)', 'description': 'Phase 2', 'interventionNames': ['Drug: BMS-908662']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-908662 + Cetuximab (B2)', 'description': 'Phase 2', 'interventionNames': ['Drug: BMS-908662', 'Drug: Cetuximab']}], 'interventions': [{'name': 'BMS-908662', 'type': 'DRUG', 'description': 'Capsules, Oral, escalating doses starting at 25 mg, every 12 hours (Q 12 h), Continuously', 'armGroupLabels': ['BMS-908662 (A1)']}, {'name': 'BMS-908662', 'type': 'DRUG', 'description': 'Capsules, Oral, (TBD) mg, Q 12 h, Continuously', 'armGroupLabels': ['BMS-908662 (B1)', 'BMS-908662 + Cetuximab (B2)']}, {'name': 'Cetuximab', 'type': 'DRUG', 'description': 'Vial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously', 'armGroupLabels': ['BMS-908662 + Cetuximab (B2)', 'Cetuximab (A1)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Oncology Research Associates D/B/A', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Usc Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': 'K1H 1C3', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}