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
Public ClinicalTrials.gov record NCT04514497. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04514497
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 29 participants
Conditions and interventions
Conditions
- Metastatic Lung Small Cell Carcinoma
- Metastatic Malignant Solid Neoplasm
- Metastatic Neuroendocrine Carcinoma
- Metastatic Pancreatic Adenocarcinoma
- Stage III Lung Cancer AJCC v8
- Stage III Pancreatic Cancer AJCC v8
- Stage IV Lung Cancer AJCC v8
- Stage IV Pancreatic Cancer AJCC v8
- Unresectable Lung Small Cell Carcinoma
- Unresectable Malignant Solid Neoplasm
- Unresectable Neuroendocrine Carcinoma
- Unresectable Pancreatic Adenocarcinoma
Interventions
- Biopsy Procedure Procedure
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- Elimusertib Drug
- Irinotecan Hydrochloride Drug
- Magnetic Resonance Imaging Procedure
- Topotecan Hydrochloride Drug
Procedure · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 20, 2021 (Actual)
- Primary completion
- Feb 15, 2025 (Actual)
- Completion
- Mar 4, 2027 (Estimated)
- Last update posted
- Sep 10, 2026
2021 – 2027
United States locations
- U.S. sites
- 23
- U.S. states
- 11
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Hospital in Arizona | Phoenix | Arizona | 85054 | — |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Smilow Cancer Hospital Care Center-Trumbull | Trumbull | Connecticut | 06611 | — |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | — |
| University of Kansas Clinical Research Center | Fairway | Kansas | 66205 | — |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | — |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | — |
| University of Kansas Hospital-Indian Creek Campus | Overland Park | Kansas | 66211 | — |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | — |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | — |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | — |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | — |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | — |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | — |
| University of Kansas Cancer Center at North Kansas City Hospital | North Kansas City | Missouri | 64116 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | — |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | — |
| Montefiore Medical Center-Einstein Campus | The Bronx | New York | 10461 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04514497, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 10, 2026 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04514497 live on ClinicalTrials.gov.