Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2026-01-04 @ 2:32 AM
Study NCT ID:
NCT06625320
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-12
First Post:
2024-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'C584112', 'term': 'irinotecan sucrosofate'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 501}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2024-09-20', 'studyFirstSubmitQcDate': '2024-10-01', 'lastUpdatePostDateStruct': {'date': '2025-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS) in the RAS G12-mutant population', 'timeFrame': 'Up to approximately 3 years', 'description': 'PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by blinded independent central review (BICR)'}, {'measure': 'Overall survival (OS) in the RAS G12-mutant population', 'timeFrame': 'Up to approximately 3 years', 'description': 'OS is defined as the time from randomization until death from any cause.'}], 'secondaryOutcomes': [{'measure': 'PFS in the all-patient population', 'timeFrame': 'Up to approximately 3 years', 'description': 'PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per RECIST v1.1 and as assessed by BICR.'}, {'measure': 'OS in the all-patient population', 'timeFrame': 'Up to approximately 3 years', 'description': 'OS is defined as the time from randomization until death from any cause.'}, {'measure': 'Objective response in the RAS G12 and all-patient populations', 'timeFrame': 'Up to approximately 3 years', 'description': 'Objective response is defined as partial response (PR) or completed response (CR) per RECIST v1.1, assessed by BICR.'}, {'measure': 'Time to deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module (EORTC QLQ-PAN26) in the RAS G12 and all-patient populations', 'timeFrame': 'Up to approximately 3 years', 'description': 'TTD is defined as the time from randomization to the first occurrence of deterioration as defined by a change of at least 10 points, or death, whichever occurs first, in each subscale in EORTC QLQ-PAN26.'}, {'measure': 'Time to deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in the RAS G12 and all-patient populations', 'timeFrame': 'Up to approximately 3 years', 'description': 'TTD is defined as the time from randomization to the first occurrence of deterioration as defined by a change of at least 10 points, or death, whichever occurs first, in each subscale and global QoL score in EORTC QLQ-C30.'}, {'measure': 'Objective response per investigator in RAS G12 and all- patient populations', 'timeFrame': 'Up to approximately 3 years', 'description': 'Objective response is defined as PR or CR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, as assessed by the investigator.'}, {'measure': 'Duration of response (DOR) in RAS G12 and all-patient populations', 'timeFrame': 'Up to approximately 3 years', 'description': 'DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first, as assessed by BICR and by the investigator.'}, {'measure': 'Time to response (TTR) in RAS G12 and all-patient populations', 'timeFrame': 'Up to approximately 3 years', 'description': 'TTR is defined as time from randomization to first evidence of objective response (PR or CR), as assessed by BICR and by the investigator.'}, {'measure': 'Percentage of patients with adverse events (AEs)', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Pharmacokinetics of RMC-6236 in RAS G12 and all-patient populations', 'timeFrame': 'Up to approximately 3 years', 'description': 'Pharmacokinetics are defined by blood concentrations of RMC-6236 over time.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic Cancer', 'PDAC', 'Pancreatic Ductal Adenocarcinoma', 'RAS', 'KRAS', 'NRAS', 'HRAS', 'RAS Wild-Type', 'RAS Q61 Mutation', 'RAS G12 Mutation', 'RAS G13 Mutation'], 'conditions': ['Pancreatic Cancer', 'PDAC', 'PDAC - Pancreatic Ductal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.', 'detailedDescription': "This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with RMC-6236 will improve progression free survival (PFS) or overall survival (OS) compared to Investigator's choice of standard of care chemotherapy in patients with metastatic PDAC who were previously treated with one prior line of therapy with 5-fluorouracil (5-FU) based or gemcitabine-based regimen.\n\nPatients will be randomized in a 1:1 ratio to receive RMC-6236 (Arm A) or Investigator's choice of standard of care chemotherapy (Arm B)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed PDAC with metastatic disease.\n* Measurable disease per RECIST 1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation)\n* Documented RAS mutation status, either mutant or wild-type. RAS mutations defined as nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).\n* History of or known central nervous system metastatic disease.\n* Any conditions that may affect the ability to take or absorb study treatment\n* Major surgery within 4 weeks prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures'}, 'identificationModule': {'nctId': 'NCT06625320', 'acronym': 'RASolute 302', 'briefTitle': 'Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Revolution Medicines, Inc.'}, 'officialTitle': "RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of Daraxonrasib (RMC-6236) Versus Investigator's Choice of Standard of Care Therapy in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)", 'orgStudyIdInfo': {'id': 'RMC-6236-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RMC-6236', 'description': 'Study drug', 'interventionNames': ['Drug: RMC-6236']}, {'type': 'ACTIVE_COMPARATOR', 'label': "Investigator's choice of standard of care therapy", 'description': "Patients randomized to Investigator's choice of standard of care chemotherapy will receive one of the following four treatments:\n\n* Gemcitabine and nab-paclitaxel (GnP)\n* Oxaliplatin, leucovorin, irinotecan, and 5-FU (Modified FOLFIRINOX: mFOLFIRINOX)\n* Liposomal irinotecan (Nal-IRI + 5-FU/LV)\n* Oxaliplatin, leucovorin and 5-FU IV (FOLFOX)", 'interventionNames': ['Drug: Gemcitabine', 'Drug: nab-paclitaxel', 'Drug: Irinotecan', 'Drug: Liposomal irinotecan', 'Drug: 5-fluorouracil', 'Drug: leucovorin', 'Drug: Oxaliplatin']}], 'interventions': [{'name': 'RMC-6236', 'type': 'DRUG', 'description': 'Oral Tablets', 'armGroupLabels': ['RMC-6236']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'intravenous (IV) infusion', 'armGroupLabels': ["Investigator's choice of standard of care therapy"]}, {'name': 'nab-paclitaxel', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ["Investigator's choice of standard of care therapy"]}, {'name': 'Irinotecan', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ["Investigator's choice of standard of care therapy"]}, {'name': 'Liposomal irinotecan', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ["Investigator's choice of standard of care therapy"]}, {'name': '5-fluorouracil', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ["Investigator's choice of standard of care therapy"]}, {'name': 'leucovorin', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ["Investigator's choice of standard of care therapy"]}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ["Investigator's choice of standard of care therapy"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center - Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope-Duarte', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Health Moores Cancer Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Mission Hall UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center - Florida', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32909', 'city': 'Palm Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer Care Centers of Brevard Inc', 'geoPoint': {'lat': 28.03446, 'lon': -80.58866}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': "The Queen's Medical Center", 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center - 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