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 (NCT04514497)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mayo Clinic Hospital in Arizona — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (23 Sites)
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
- Yale University — New Haven, Connecticut
- Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut
- Mayo Clinic in Florida — Jacksonville, Florida
- University of Kansas Clinical Research Center — Fairway, Kansas
- University of Kansas Cancer Center — Kansas City, Kansas
- University of Kansas Cancer Center-Overland Park — Overland Park, Kansas
- University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas
- University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas
- Mayo Clinic in Rochester — Rochester, Minnesota
- Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri
- Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri
- University of Kansas Cancer Center - North — Kansas City, Missouri
- University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri
- University of Kansas Cancer Center at North Kansas City Hospital — North Kansas City, Missouri
- Washington University School of Medicine — St Louis, Missouri
- Siteman Cancer Center-South County — St Louis, Missouri
- Siteman Cancer Center at Christian Hospital — St Louis, Missouri
- Montefiore Medical Center-Einstein Campus — The Bronx, New York
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee
📞 Contact the Study Coordinator
Phone: (800) 664-4580
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.