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Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer
Sponsor: National Cancer Institute (NCI)
Summary
This phase I trial tests the safety, side effects and best dose of BAY 1895344 when given together with usual chemotherapy (irinotecan or topotecan) in treating patients with solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), with a specific focus on small cell lung cancer, poorly differentiated neuroendocrine cancer, and pancreatic cancer. BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as irinotecan and topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding BAY 1895344 to irinotecan or topotecan may be safe and tolerable in treating patients with advanced solid tumors.
Official title: BAY 1895344 Plus Topoisomerase-1 (Top1) Inhibitors in Patients With Advanced Solid Tumors, Phase I Studies With Expansion Cohorts in Small Cell Lung Carcinoma (SCLC), Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) and Pancreatic Adenocarcinoma (PDA)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
28
Start Date
2021-10-20
Completion Date
2026-03-04
Last Updated
2025-03-06
Healthy Volunteers
No
Conditions
Interventions
Biopsy
Undergo tumor biopsy
Biospecimen Collection
Undergo collection of blood samples
Computed Tomography
Undergo CT
Elimusertib
Given PO
Irinotecan Hydrochloride
Given IV
Magnetic Resonance Imaging
Undergo MRI
Topotecan Hydrochloride
Given IV
Locations (23)
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Yale University
New Haven, Connecticut, United States
Smilow Cancer Hospital Care Center-Trumbull
Trumbull, Connecticut, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
University of Kansas Clinical Research Center
Fairway, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center-South County
St Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States