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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 12:02 AM

Ignite Modification Date: 2025-12-25 @ 9:59 PM

Study NCT ID: NCT04793958

Status: ACTIVE_NOT_RECRUITING

Last Update Posted: 2025-02-11

First Post: 2021-03-02

Is NOT Gene Therapy: False

Has Adverse Events: False

Brief Title: Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic 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': 'C000718190', 'term': 'adagrasib'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 461}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT05162443', 'statusForNctId': 'APPROVED_FOR_MARKETING', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-03-08', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': '30 months', 'description': 'Defined as time from date of randomization to date of death due to any cause.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': '30 months', 'description': 'Defined as time from randomization until disease progression or death from any cause, whichever occurs first.'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '30 months', 'description': 'Defined as number of patients with treatment emergent AEs.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': '30 months', 'description': 'Defined as the percent of patients documented to have a confirmed CR or PR.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': '30 months', 'description': 'Defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of either Progression of Disease (PD) or death due to any cause, whichever occurs first.'}, {'measure': 'Patient Reported Outcomes (PROs)', 'timeFrame': '30 months', 'description': 'To be assessed by European Quality of Life Questionnaire for Cancer Patients (QLQ-C30).'}, {'measure': 'Quality of Life Assessment', 'timeFrame': '30 months', 'description': 'To be assessed by European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal Cancer', 'Colorectal Cancer Trial', 'Colorectal Carcinoma', 'Rectal Cancer', 'Colon Cancer', 'KRAS', 'KRAS G12C', 'RAS', 'Colorectal Adenocarcinoma'], 'conditions': ['Advanced Colorectal Cancer', 'Metastatic Colorectal Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.\n* Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.\n\nExclusion Criteria:\n\n* Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).\n* Active brain metastasis'}, 'identificationModule': {'nctId': 'NCT04793958', 'briefTitle': 'Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mirati Therapeutics Inc.'}, 'officialTitle': 'A Randomized Phase 3 Study of MRTX849 in Combination With Cetuximab Versus Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation With Disease Progression On or After Standard First-Line Therapy', 'orgStudyIdInfo': {'id': 'CA239-0006'}, 'secondaryIdInfos': [{'id': 'KRYSTAL-10', 'type': 'OTHER', 'domain': 'Mirati Therapeutics'}, {'id': 'CA239-0006', 'type': 'OTHER', 'domain': 'Bristol-Myers Squibb Protocol ID'}, {'id': '849-010', 'type': 'OTHER', 'domain': 'Mirati Therapeutics Protocol ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MRTX849 + Cetuximab', 'interventionNames': ['Drug: MRTX849', 'Biological: Cetuximab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'mFOLFOX6 or FOLFIRI', 'interventionNames': ['Drug: mFOLFOX6 Regimen', 'Drug: FOLFIRI Regimen']}], 'interventions': [{'name': 'MRTX849', 'type': 'DRUG', 'description': '28 Day Cycle', 'armGroupLabels': ['MRTX849 + Cetuximab']}, {'name': 'Cetuximab', 'type': 'BIOLOGICAL', 'otherNames': ['Erbitux'], 'description': '28 Day Cycle', 'armGroupLabels': ['MRTX849 + Cetuximab']}, {'name': 'mFOLFOX6 Regimen', 'type': 'DRUG', 'description': '* Fluorouracil\n* Oxaliplatin\n* Folinic acid', 'armGroupLabels': ['mFOLFOX6 or FOLFIRI']}, {'name': 'FOLFIRI Regimen', 'type': 'DRUG', 'description': '* Fluorouracil\n* Irinotecan\n* Folinic acid', 'armGroupLabels': ['mFOLFOX6 or FOLFIRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35007', 'city': 'Alabaster', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution - 010-855-E', 'geoPoint': {'lat': 33.24428, 'lon': -86.81638}}, {'zip': '35022', 'city': 'Bessemer', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution - 010-855-B', 'geoPoint': {'lat': 33.40178, 'lon': -86.95444}}, {'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution - 010-855-D', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Local Institution - 010-855-A', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 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