NCT04491942View on ClinicalTrials.gov

Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

August 25, 2021

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Advanced Bile Duct CarcinomaAdvanced Breast CarcinomaAdvanced Cervical CarcinomaAdvanced Endometrial CarcinomaAdvanced Esophageal CarcinomaAdvanced Gastric CarcinomaAdvanced Head and Neck CarcinomaAdvanced Lung Non-Small Cell CarcinomaAdvanced Lung Small Cell CarcinomaAdvanced Malignant Solid NeoplasmAdvanced Ovarian CarcinomaAdvanced Penile CarcinomaAdvanced Pleural Malignant MesotheliomaAdvanced Urothelial CarcinomaAnatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Clinical Stage III Gastric Cancer AJCC v8Clinical Stage IV Gastric Cancer AJCC v8Stage III Cervical Cancer AJCC v8Stage III Distal Bile Duct Cancer AJCC v8Stage III Intrahepatic Bile Duct Cancer AJCC v8Stage III Lung Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Stage III Penile Cancer AJCC v8Stage III Pleural Malignant Mesothelioma AJCC v8Stage IV Cervical Cancer AJCC v8Stage IV Distal Bile Duct Cancer AJCC v8Stage IV Intrahepatic Bile Duct Cancer AJCC v8Stage IV Lung Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Penile Cancer AJCC v8Stage IV Pleural Malignant Mesothelioma AJCC v8Triple-Negative Breast CarcinomaUnresectable Urothelial Carcinoma
Interventions
DRUG

Cisplatin

Given IV

DRUG

Elimusertib

Given PO

DRUG

Gemcitabine Hydrochloride

Given IV

Trial Locations (8)

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

43210

Ohio State University Comprehensive Cancer Center, Columbus

53792

University of Wisconsin Carbone Cancer Center - University Hospital, Madison

95817

University of California Davis Comprehensive Cancer Center, Sacramento

M5G 2M9

University Health Network-Princess Margaret Hospital, Toronto

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH