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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 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.

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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.

Interventions

  • DRUG Talazoparib Tosylate
  • DRUG Trifluridine and Tipiracil Hydrochloride

Study Locations (1)

New York

  • Roswell Park Cancer Institute - Buffalo

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2021-06-08
Est. Completion 2027-04-01
Phase Phase 1

Sponsor

Roswell Park Cancer Institute

365 total trials

What the Registry Record Tells You About NCT04511039

The ClinicalTrials.gov registry entry for NCT04511039 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 45 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 (74% lower). The listed sponsor is Roswell Park Cancer Institute, which has 365 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 2 interventions - of which Talazoparib Tosylate is the first listed.

NCT04511039 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.

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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.