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NCT04491942 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Malignant Solid Neoplasm and Advanced Lung Non-Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
74
Enrollment target
8
Study locations

NCT04491942 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Advanced Lung Non-Small Cell Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 74 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (58% lower). The trial reports 8 study locations across 7 states.

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The verdict

NCT04491942, a Phase 1 study of Advanced Malignant Solid Neoplasm and Advanced Lung Non-Small Cell Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
74 participants
Enrollment target
8
Study locations

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.

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

FieldValue
Enrollment Target 74 participants
Start Date 2021-08-25
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT04491942

The ClinicalTrials.gov registry entry for NCT04491942 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (58% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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.

NCT04491942 reports 8 study locations spanning 7 distinct geographic areas - top geographies include Maryland, California, New York.

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.

What interventions are being tested in trial NCT04491942?

The interventions under investigation include: Cisplatin (DRUG), Gemcitabine Hydrochloride (DRUG), Elimusertib (DRUG).

Who is sponsoring clinical trial NCT04491942?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.