Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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
NCT04491942 · View on ClinicalTrials.gov ↗
Study Summary
This phase I trial identifies the best dose, possible benefits and/or side effects of BAY 1895344 in combination with chemotherapy in treating patients with solid tumors or urothelial cancer that has spread to other places in the body (advanced). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cisplatin and gemcitabine are chemotherapy drugs that stop the growth of tumor cells by killing the cells. Combining BAY 1895344 with chemotherapy treatment (cisplatin, or cisplatin and gemcitabine) may be effective for the treatment of advanced solid tumors, including urothelial cancer.
Conditions Studied
Interventions
- DRUG Cisplatin
- DRUG Gemcitabine Hydrochloride
- DRUG Elimusertib
Study Locations (8)
Maryland
- National Cancer Institute Developmental Therapeutics Clinic — Bethesda
- National Institutes of Health Clinical Center — Bethesda
California
- University of California Davis Comprehensive Cancer Center — Sacramento
New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center — New York
Ohio
- Ohio State University Comprehensive Cancer Center — Columbus
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) — Pittsburgh
Wisconsin
- University of Wisconsin Carbone Cancer Center - University Hospital — Madison
Ontario
- University Health Network-Princess Margaret Hospital — Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2021-08-25 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04491942
The ClinicalTrials.gov registry entry for NCT04491942 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 74 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 Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 3 interventions — of which Cisplatin 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: NCT04491942 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Maryland, California, New York. 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 NCT04491942 about?
NCT04491942 is a clinical study titled "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". This phase I trial identifies the best dose, possible benefits and/or side effects of BAY 1895344 in combination with chemotherapy in treating patients with solid tumors or urothelial cancer that has spread to other places in the body (advanced). BAY 1895344 may stop the growth of tumor cells by blo...
What is the current status of trial NCT04491942?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2021-08-25. Estimated completion is 2026-06-30.
What conditions does trial NCT04491942 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Advanced Lung Non-Small Cell Carcinoma, Advanced Breast Carcinoma, Advanced Endometrial Carcinoma, Advanced Gastric Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04491942?
The interventions under investigation include: Cisplatin (DRUG), Gemcitabine Hydrochloride (DRUG), Elimusertib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04491942?
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 NCT04491942 being conducted?
This trial has 8 study locations across California, Maryland, New York, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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