Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-25 @ 7:34 PM
Study NCT ID:
NCT07252232
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Daraxonrasib (RMC-6236) in Patients With Resected 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-Free Survival (DFS) per Investigator', 'timeFrame': 'Up to approximately 5 years', 'description': 'DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by Investigator.'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Up to approximately 5 years', 'description': 'OS is defined as the time from randomization until death from any cause.'}, {'measure': 'DFS per blinded independent central review (BICR)', 'timeFrame': 'Up to approximately 5 years', 'description': 'DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per RECIST v1.1 as assessed by BICR.'}, {'measure': 'DFS Rate at 1 year and 2 years', 'timeFrame': 'Up to approximately 2 years', 'description': 'DFS rate defined as percentage of patients who are disease free at 1 year and 2 years, respectively.'}, {'measure': 'OS rate at 1 year and 2 years', 'timeFrame': 'Up to approximately 2 years', 'description': 'OS rate defined as percentage of patients who are alive at 1 year and 2 years, respectively.'}, {'measure': 'Safety and tolerability of daraxonrasib', 'timeFrame': 'Up to approximately 5 years', 'description': 'Incidence of adverse events (AEs) and changes from baseline in vital signs, ECOG performance score, and clinical laboratory tests.'}, {'measure': 'Pharmacokinetics (PK)', 'timeFrame': 'Up to Cycle 4 Day 1 (Day 85)', 'description': 'Predose concentration of daraxonrasib'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic Cancer', 'PDAC', 'Pancreatic Ductal Adenocarcinoma', 'RAS', 'KRAS', 'NRAS', 'HRAS', 'RAS Wild-Type', 'RASolute', 'Resectable Pancreatic Ductal Adenocarcinoma', 'Resectable PDAC', 'Resected Pancreatic Adenocarcinoma', 'RAS Mutation'], 'conditions': ['Pancreatic Cancer', 'PDAC', 'PDAC - Pancreatic Ductal Adenocarcinoma', 'Resectable Pancreatic Ductal Adenocarcinoma (PDAC)', 'Resected Pancreatic Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard of care (SOC) observation only.', 'detailedDescription': 'This is a global, randomized, open-label, Phase 3 study designed to evaluate whether treatment with daraxonrasib will improve disease-free survival (DFS) compared to SOC observation in patients with resected PDAC who have completed neoadjuvant and/or adjuvant chemotherapy.'}, '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 confirmed PDAC with successful (R0/R1) curative intent surgical resection and no evidence of recurrent or metastatic disease.\n* Must have received perioperative (neoadjuvant, adjuvant, or a combination of both) multi-agent chemotherapy.\n* Must have completed most recent treatment within the past 12 weeks.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Documented RAS mutation status.\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior therapy with direct RAS-targeted therapy (eg. degraders and/or inhibitors).\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.'}, 'identificationModule': {'nctId': 'NCT07252232', 'acronym': 'RASolute 304', 'briefTitle': 'Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Revolution Medicines, Inc.'}, 'officialTitle': 'RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2-Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)', 'orgStudyIdInfo': {'id': 'RMC-6236-304'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'daraxonrasib', 'description': 'study drug', 'interventionNames': ['Drug: daraxonrasib']}, {'type': 'NO_INTERVENTION', 'label': 'SOC Observation', 'description': 'Patients randomized to the comparator control arm will receive SOC observation.'}], 'interventions': [{'name': 'daraxonrasib', 'type': 'DRUG', 'description': 'oral tablets', 'armGroupLabels': ['daraxonrasib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06103', 'city': 'Hartford', 'state': 'Connecticut', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan Steinmetz', 'role': 'CONTACT', 'email': 'jsteinmetz@uchc.edu', 'phone': '(917) 436-3006'}], 'facility': 'Hartford Healthcare', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marc Roth', 'role': 'CONTACT', 'email': 'mroth@saint-lukes.org', 'phone': '(816) 932-2677'}], 'facility': "Saint Luke's Cancer Institute", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '43537', 'city': 'Maumee', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'sambrose@tcrcpt.org', 'phone': '567-402-4502'}], 'facility': 'Taylor Cancer Research Center', 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}, {'zip': '57105', 'city': 'Sioux Falls', 'state': 'South Dakota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'heidi.mckean@avera.org', 'phone': '605-322-6900'}], 'facility': 'Avera Cancer Institute', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '00935', 'city': 'Río Piedras', 'state': 'Puerto Rico', 'status': 'RECRUITING', 'country': 'Puerto Rico', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'info@panoncologytrials.com', 'phone': '787-407-3333'}], 'facility': 'Pan American Oncology Trials, LLC'}], 'centralContacts': [{'name': 'Revolution Medicines Study Director', 'role': 'CONTACT', 'email': 'medinfo@revmed.com', 'phone': '1-844-2-REVMED'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Revolution Medicines, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}