RecruitingPhase 1NCT04511039

Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer

A Phase I Study of Trifluridine/ Tipiracil Plus the Poly (ADP) Ribose Polymerase Inhibitor Talazoparib in Advanced Cancers

Sponsor

Roswell Park Cancer Institute

Enrollment

45 participants

Start Date

Jun 8, 2021

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether combining two drugs — trifluridine/tipiracil (a chemotherapy tablet) and talazoparib (a PARP inhibitor that blocks cancer cell DNA repair) — can help people with advanced colorectal cancer or stomach/esophageal cancer that is no longer responding to standard chemotherapy. **You may be eligible if...** - You have advanced (locally advanced or metastatic) colorectal cancer or esophagogastric adenocarcinoma - You have already received at least one prior line of treatment that is no longer working - You are 18 or older and in adequate overall health - You have measurable disease on imaging scans **You may NOT be eligible if...** - You have had prior treatment with trifluridine/tipiracil or talazoparib - You have significant bone marrow suppression - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrifluridine and Tipiracil Hydrochloride

Given PO

DRUGTalazoparib Tosylate

Given PO

Locations(1)

Roswell Park Cancer Institute

Buffalo, New York, United States

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NCT04511039

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