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ACTIVE NOT RECRUITING Phase 1

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 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy
  • DRUG Irinotecan Hydrochloride
  • DRUG Elimusertib

Study Locations (20)

Missouri

  • Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters
  • Siteman Cancer Center at West County Hospital — Creve Coeur
  • University of Kansas Cancer Center - North — Kansas City
  • University of Kansas Cancer Center - Lee's Summit — Lee's Summit
  • University of Kansas Cancer Center at North Kansas City Hospital — North Kansas City
  • Washington University School of Medicine — St Louis
  • Siteman Cancer Center-South County — St Louis
  • Siteman Cancer Center at Christian Hospital — St Louis

Kansas

  • University of Kansas Clinical Research Center — Fairway
  • University of Kansas Cancer Center — Kansas City
  • University of Kansas Cancer Center-Overland Park — Overland Park
  • University of Kansas Hospital-Indian Creek Campus — Overland Park
  • University of Kansas Hospital-Westwood Cancer Center — Westwood

Connecticut

  • Yale University — New Haven
  • Smilow Cancer Hospital Care Center-Trumbull — Trumbull

Arizona

  • Mayo Clinic Hospital in Arizona — Phoenix

California

  • UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange

Florida

  • Mayo Clinic in Florida — Jacksonville

Minnesota

  • Mayo Clinic in Rochester — Rochester

New York

  • Montefiore Medical Center-Einstein Campus — The Bronx

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2021-10-20
Est. Completion 2026-03-04
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04514497

The ClinicalTrials.gov registry entry for NCT04514497 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04514497 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Missouri, Kansas, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04514497 about?

NCT04514497 is a clinical study titled "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". 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 (ad...

What is the current status of trial NCT04514497?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2021-10-20. Estimated completion is 2026-03-04.

What conditions does trial NCT04514497 study?

This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Stage IV Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8, Metastatic Pancreatic Adenocarcinoma, Stage IV Pancreatic Cancer AJCC v8. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04514497?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Irinotecan Hydrochloride (DRUG), Elimusertib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04514497?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04514497 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial