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NCT04511039 · ClinicalTrials.gov registry record · Phase 1
Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer
A Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Colorectal Adenocarcinoma, sponsored by Roswell Park Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT04511039: Recruiting Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Colorectal Adenocarcinoma, sponsored by Roswell Park Cancer Institute.
NCT04511039 is a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Colorectal Adenocarcinoma that is actively recruiting participants, run by Roswell Park Cancer Institute. The registered enrollment target is 45 participants, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04511039, a Phase 1 study of Advanced Malignant Solid Neoplasm and Metastatic Colorectal Adenocarcinoma, is actively recruiting participants, sponsored by Roswell Park Cancer Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial investigates the side effects and best dose of talazoparib when given together with trifluridine/tipiracil for the treatment of patients with colorectal or gastroesophageal cancer that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). Drugs used in the chemotherapy, such as trifluridine/tipiracil, 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. Talazoparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving talazoparib with trifluridine/ tipiracil may inhibit certain enzymes in the cells that are responsible for tumor cell growth.
Primary Outcome
All adverse events will be evaluated using Common Terminology Criteria for All Adverse Events (CTCAE) version (v.) 5.
Conditions Studied
Interventions
- DRUG Talazoparib Tosylate
- DRUG Trifluridine and Tipiracil Hydrochloride
Study Locations (1)
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2021-06-08 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 1 |
What NCT04511039 shows while recruiting
NCT04511039 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 176-participant average among 108 other Advanced Malignant Solid Neoplasm trials with a reported enrollment target (74% lower).
The record links to 10 conditions, with Advanced Malignant Solid Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Talazoparib Tosylate is the first listed.
NCT04511039 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04511039 about?
NCT04511039 is a clinical study titled "Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer". This phase I trial investigates the side effects and best dose of talazoparib when given together with trifluridine/tipiracil for the treatment of patients with colorectal or gastroesophageal cancer that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metas...
What is the current status of trial NCT04511039?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2021-06-08. Estimated completion is 2027-04-01.
What conditions does trial NCT04511039 study?
This clinical trial studies the following conditions: Advanced Malignant Solid Neoplasm, Metastatic Colorectal Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma, Locally Advanced Gastroesophageal Junction Adenocarcinoma, Locally Advanced Colorectal Carcinoma.
What interventions are being tested in trial NCT04511039?
The interventions under investigation include: Talazoparib Tosylate (DRUG), Trifluridine and Tipiracil Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04511039?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04511039 being conducted?
This trial has 1 study location across New York. 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 NCT04511039's enrollment target sits among peer trials
45 55th of 108 higher than 54 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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