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Recruiting Phase 1 NCT04511039

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

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Trial Parameters

Condition Advanced Malignant Solid Neoplasm
Sponsor Roswell Park Cancer Institute
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 45
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-06-08
Completion 2026-09-01
All Conditions
Advanced Malignant Solid Neoplasm Clinical Stage III Gastroesophageal Junction Adenocarcinoma Clinical Stage IV Gastroesophageal Junction Adenocarcinoma Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma A Locally Advanced Colorectal Carcinoma Locally Advanced Gastroesophageal Junction Adenocarcinoma Metastatic Colorectal Adenocarcinoma Metastatic Gastroesophageal Junction Adenocarcinoma Pathologic Stage III Gastroesophageal Junction Adenocarcinoma Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8 Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8 Stage III Colorectal Cancer AJCC v8 Stage IIIA Colorectal Cancer AJCC v8 Stage IIIB Colorectal Cancer AJCC v8 Stage IIIC Colorectal Cancer AJCC v8 Stage IV Colorectal Cancer AJCC v8 Stage IVA Colorectal Cancer AJCC v8 Stage IVB Colorectal Cancer AJCC v8 Stage IVC Colorectal Cancer AJCC v8
Interventions
Trifluridine and Tipiracil HydrochlorideTalazoparib Tosylate

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Brief 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 Criteria

Inclusion Criteria: * Histologically or cytologically confirmed CRC or EGC adenocarcinoma that is locally advanced or metastatic (Cohort A); histologically or cytologically confirmed p53mt/RASonc (Cohort B1) or p53mt/RASwt CRC (Cohort B2) that is locally advanced or metastatic. Patients with adenocarcinoma histology only are allowed to participate. * Has received at least one prior line of therapy with progression or intolerance * Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Life expectancy \>= 3 months by investigator assessment * Hemoglobin \>= 9 g/dL * Absolute neutrophil count \>= 1500/mm\^3 * Platelet count \>= 100,000/mm\^3 without transfusion or growth factor support * Creatinine \< 1.5 upper limit of normal (ULN) or creatinine clearance \> 60 mL/min * Total bilirubin \< 1.5 x ULN * Aspartate aminotransferase (AST)/alanine aminotransferase (AL

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