NCT04535401View on ClinicalTrials.gov

Testing the Addition of an Anticancer Drug, BAY 1895344, to the Usual Chemotherapy With FOLFIRI in Advanced or Metastatic Cancers of the Stomach and Intestines

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

August 13, 2021

Primary Completion Date

March 29, 2024

Study Completion Date

April 29, 2025

Conditions
Advanced Colorectal CarcinomaAdvanced Digestive System CarcinomaAdvanced Gastric CarcinomaAdvanced Gastroesophageal Junction AdenocarcinomaClinical Stage III Gastric Cancer AJCC v8Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8Metastatic Colorectal CarcinomaMetastatic Digestive System CarcinomaMetastatic Gastric CarcinomaMetastatic Gastroesophageal Junction AdenocarcinomaStage III Colorectal Cancer AJCC v8Stage IV Colorectal Cancer AJCC v8
Interventions
PROCEDURE

Biopsy

Undergo tumor biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Diagnostic Imaging

Undergo imaging

DRUG

Elimusertib

Given PO

DRUG

Fluorouracil

Given IV

DRUG

Irinotecan Hydrochloride

Given IV

DRUG

Leucovorin Calcium

Given IV

Trial Locations (10)

10032

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center, New York

15232

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

20892

National Cancer Institute Developmental Therapeutics Clinic, Bethesda

National Institutes of Health Clinical Center, Bethesda

63110

Washington University School of Medicine, St Louis

63129

Siteman Cancer Center-South County, St Louis

63136

Siteman Cancer Center at Christian Hospital, St Louis

63141

Siteman Cancer Center at West County Hospital, Creve Coeur

63376

Siteman Cancer Center at Saint Peters Hospital, City of Saint Peters

91010

City of Hope Comprehensive Cancer Center, Duarte

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH