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NCT04616534 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of an Anti-cancer Drug, Elimusertib (BAY 1895344) ATR Inhibitor, to the Chemotherapy Treatment (Gemcitabine) for Advanced Pancreatic and Ovarian Cancer, and Advanced Solid Tumors
A Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Pancreatic Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 3
- Study locations
NCT04616534: Active Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Pancreatic Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT04616534 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Pancreatic Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants, below the 177-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (92% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04616534, a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Pancreatic Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I trial identifies the best dose, possible benefits and/or side effects of gemcitabine in combination with elimusertib (BAY 1895344) in treating patients with pancreatic, ovarian, and other solid tumors that have spread to other places in the body (advanced). Gemcitabine is a chemotherapy drug that blocks the cell from making DNA and may kill tumor cells. elimusertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine and elimusertib in combination may shrink or stabilize cancer.
Primary Outcome
The toxicity of the combination of gemcitabine plus elimusertib will be assessed with Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0 criteria. The safety and tolerability were evaluated using the number of treatment-related adverse events.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy Procedure
- DRUG Gemcitabine
- PROCEDURE Diagnostic Imaging Testing
- DRUG Elimusertib
Study Locations (3)
Maryland
- National Cancer Institute Developmental Therapeutics Clinic - Bethesda
- National Institutes of Health Clinical Center - Bethesda
Massachusetts
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2026-05-20 |
| Phase | Phase 1 |
What the registry record for NCT04616534 still lists
NCT04616534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 177-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (92% lower).
The record links to 10 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04616534 reports a single indexed study location in Maryland, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04616534 about?
NCT04616534 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, Elimusertib (BAY 1895344) ATR Inhibitor, to the Chemotherapy Treatment (Gemcitabine) for Advanced Pancreatic and Ovarian Cancer, and Advanced Solid Tumors". This phase I trial identifies the best dose, possible benefits and/or side effects of gemcitabine in combination with elimusertib (BAY 1895344) in treating patients with pancreatic, ovarian, and other solid tumors that have spread to other places in the body (advanced). Gemcitabine is a chemotherapy...
What is the current status of trial NCT04616534?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2021-06-01. Estimated completion is 2026-05-20.
What conditions does trial NCT04616534 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma, Platinum-Resistant Ovarian Carcinoma, Platinum-Resistant Fallopian Tube Carcinoma, Advanced Ovarian Carcinoma.
What interventions are being tested in trial NCT04616534?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Biopsy Procedure (PROCEDURE), Gemcitabine (DRUG), Diagnostic Imaging Testing (PROCEDURE), Elimusertib (DRUG).
Who is sponsoring clinical trial NCT04616534?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04616534 being conducted?
This trial has 3 study locations across Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04616534's enrollment target sits among peer trials
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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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