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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: Active Phase 1 study of Advanced Malignant Solid Neoplasm and Advanced Lung Non-Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Toxicities will be tabulated and reported according to dose level, grade, type, cycle, and attribution. Tables will be created to summarize these toxicities and side effects, overall and by cohort. Proportions and associated 95% confidence intervals will be calculated for each cohort separately. Cumulative incidence curves will be used to estimate the proportion of patients who will discontinue therapy for reasons of toxicity or general inability to tolerate the regimen.
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 |
What the registry record for NCT04491942 still lists
NCT04491942 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (58% lower).
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 lists 8 locations in 7 states (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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04491942's enrollment target sits among peer trials
74 32nd of 108 higher than 77 of 108 other Advanced Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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