Viewing Study NCT05147350

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

Ignite Creation Date: 2025-12-24 @ 5:15 PM

Ignite Modification Date: 2026-02-21 @ 11:18 PM

Study NCT ID: NCT05147350

Status: TERMINATED

Last Update Posted: 2025-12-05

First Post: 2021-11-03

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Study of RP-6306 With FOLFIRI in Advanced Solid Tumors

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C480833', 'term': 'IFL protocol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clininfo@reparerx.com', 'phone': '857-340-5402', 'title': 'Repare Therapeutics Medical Monitor', 'organization': 'Repare Therapeutics INC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Start of treatment to 30 days post last dose. up to 1.5 years', 'eventGroups': [{'id': 'EG000', 'title': '40 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '40 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': '120 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '120 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 3, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': '180 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '180 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 9, 'seriousNumAtRisk': 9, 'deathsNumAffected': 3, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': '240 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '240 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 2, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': '60 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '60 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 2, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': '80 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '80 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': '80 mg BID RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI', 'description': '80 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': '120 mg QD RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI', 'description': '120 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 3, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomitting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, 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daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'OG003', 'title': '240 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '240 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'OG004', 'title': '60 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '60 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin 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bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'OG007', 'title': '120 mg QD RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI', 'description': '120 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Start of treatment to 30 days post last dose. up to 1.5 years', 'description': 'Incidence of grade 3 and above Treatment Related Emergent Adverse Events (TRAEs)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Recommended Phase 2 Dose (RP2D) and Schedule of RP-6306 in Combination With FOLFIRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '40 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '40 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'OG001', 'title': '120 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '120 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'OG002', 'title': '180 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '180 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'OG003', 'title': '240 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '240 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'OG004', 'title': '60 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '60 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'OG005', 'title': '80 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '80 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'OG006', 'title': '80 mg BID RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI', 'description': '80 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'OG007', 'title': '120 mg QD RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI', 'description': '120 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During 28 days (2 cycles) from the initiation of the study treatment', 'description': 'Evaluation of dose-limiting toxicities (DLTs) at or below a frequency of 25%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'DLT evaluable'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '40 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '40 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'FG001', 'title': '120 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '120 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'FG002', 'title': '180 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '180 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'FG003', 'title': '240 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '240 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'FG004', 'title': '60 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '60 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan 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'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'Sponsor Decision to Terminate Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}]}, {'type': 'Other Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '38', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': '40 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '40 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'BG001', 'title': '120 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '120 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'BG002', 'title': '180 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '180 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'BG003', 'title': '240 mg QD RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '240 mg QD oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'BG004', 'title': '60 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '60 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'BG005', 'title': '80 mg BID RP-6306 (Lunresertib) Daily + FOLFIRI', 'description': '80 mg BID oral (PO) lunresertib daily in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'BG006', 'title': '80 mg BID RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI', 'description': '80 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'BG007', 'title': '120 mg QD RP-6306 (Lunresertib) 3 Days on and 4 Days Off + FOLFIRI', 'description': '120 mg BID oral (PO) lunresertib 3 days on and 4 days off in combination with 180 mg/m2 intravenous (IV) irinotecan given over 30 to 90 minutes, 400 mg/m2 IV leucovorin given over 30 to 90 minutes with irinotecan, and 400 mg/m2 IV fluorouracil bolus after leucovorin, then 2400 mg/m2 IV continuous IV of fluorouracil over 46 hours (Days 1 and 2) of each 14-day cycle'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '53'}, {'value': '55', 'groupId': 'BG001', 'lowerLimit': '51', 'upperLimit': '59'}, {'value': '58', 'groupId': 'BG002', 'lowerLimit': '50', 'upperLimit': '73'}, {'value': '66', 'groupId': 'BG003', 'lowerLimit': '55', 'upperLimit': '70'}, {'value': '68', 'groupId': 'BG004', 'lowerLimit': '31', 'upperLimit': '75'}, {'value': '42', 'groupId': 'BG005', 'lowerLimit': '38', 'upperLimit': '60'}, {'value': '44', 'groupId': 'BG006', 'lowerLimit': '41', 'upperLimit': '53'}, {'value': '61', 'groupId': 'BG007', 'lowerLimit': '46', 'upperLimit': '78'}, {'value': '55.5', 'groupId': 'BG008', 'lowerLimit': '31', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '21', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': 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'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-15T16:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Dose Escalation and expansion'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': 'Sponsor decided to terminate the study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-28', 'studyFirstSubmitDate': '2021-11-03', 'resultsFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2021-12-06', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-05', 'studyFirstPostDateStruct': {'date': '2021-12-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability of RP 6306 in Combination With FOLFIRI', 'timeFrame': 'Start of treatment to 30 days post last dose. up to 1.5 years', 'description': 'Incidence of grade 3 and above Treatment Related Emergent Adverse Events (TRAEs)'}, {'measure': 'Recommended Phase 2 Dose (RP2D) and Schedule of RP-6306 in Combination With FOLFIRI', 'timeFrame': 'During 28 days (2 cycles) from the initiation of the study treatment', 'description': 'Evaluation of dose-limiting toxicities (DLTs) at or below a frequency of 25%.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to assess the safety and tolerability of RP-6306 with FOLFIRI in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD), identify a recommended phase 2 dose (RP2D) and preferred schedule, and assess preliminary anti-tumor activity.', 'detailedDescription': "To assess the safety and tolerability of RP-6306 in combination with FOLFIRI in patients with eligible, advanced solid tumors. Incidence and severity of treatment-emergent adverse events (TEAEs), laboratory assessments, vital signs, electrocardiograms (ECGs), and use of concomitant medications.\n\nThe Sponsor of the study has changed from 'Repare Therapeutics' to 'Debiopharm International SA' in the United States."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female and ≥18 years-of-age at the time of signature of the informed consent\n* Confirmed advanced solid tumors resistant or refractory to standard treatment\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.\n* All patients must have locally advanced or metastatic CRC, GI, or esophageal cancer(s) and radiographic evidence of progressing disease.\n* Measurable disease as per RECIST v1.1\n* Submission of available tumor tissue or willingness to have a biopsy performed if safe and feasible\n* Acceptable hematologic and organ function at screening\n* Negative pregnancy test for women of childbearing potential at Screening and prior to first study drug.\n\nExclusion Criteria:\n\n* Inability to swallow and retain oral medications.\n* Chemotherapy or small molecule antineoplastic agent given within 21 days or \\<5 half- lives, whichever is shorter, prior to first dose of study treatment.\n* History or current condition, therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment.\n* Patients who are pregnant or breastfeeding\n* Life-threatening illness, medical condition, active uncontrolled infection, or organ system dysfunction or other reasons which, in the investigator's opinion, could compromise the participating patient's safety.\n* Major surgery within 4 weeks prior to first study treatment dose.\n* Uncontrolled, symptomatic brain metastases.\n* Uncontrolled high blood pressure\n* Active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS) related illness.\n* Moderate or severe hepatic impairment\n* Cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) ≥Class 2\n* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol."}, 'identificationModule': {'nctId': 'NCT05147350', 'acronym': 'MINOTAUR', 'briefTitle': 'Study of RP-6306 With FOLFIRI in Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Debiopharm International SA'}, 'officialTitle': 'Phase 1 Study of the PKMYT1 Inhibitor RP-6306 in Combination With FOLFIRI for the Treatment of Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'RP-6306-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1: RP-6306 in combination with FOLFIRI Dose Escalation', 'description': 'RP-6306 will be administered as oral capsules Multiple dose levels of RP-6306 (oral) and FOLFIRI (IV)', 'interventionNames': ['Drug: RP-6306 (oral PKMYT1 inhibitor)']}], 'interventions': [{'name': 'RP-6306 (oral PKMYT1 inhibitor)', 'type': 'DRUG', 'otherNames': ['FOLFIRI'], 'description': 'RP-6306 (Oral) in combination with FOLFIRI (IV)', 'armGroupLabels': ['Phase 1: RP-6306 in combination with FOLFIRI Dose Escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': '#1019, UCLA, Westwood Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': '#1022, Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': '#1008, Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': '#1001, The University of Texas M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': '#1013, The University of Utah, Huntsman Cancer Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': 'ON M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': '# 2001, Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Madrid', 'country': 'Spain', 'facility': '# 5002, South Texas Accelerated Research Therapeutics', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': '# 5003, Hospital Universitario HM Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'W1G 6AD', 'city': 'London', 'country': 'United Kingdom', 'facility': '# 3003, Sarah Cannon Research Institute', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Debiopharm International SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Repare Therapeutics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}