OncoMatch/Clinical Trials/NCT04511039
Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer
Is NCT04511039 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Trifluridine and Tipiracil Hydrochloride and Talazoparib Tosylate for advanced malignant solid neoplasm.
Treatment: Trifluridine and Tipiracil Hydrochloride · Talazoparib Tosylate — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Gastric Cancer
Esophageal Carcinoma
Colorectal Cancer
Biomarker criteria
Required: TP53 mutation
p53mt/RASonc (Cohort B1) or p53mt/RASwt CRC (Cohort B2)
Required: KRAS mutation
p53mt/RASonc (Cohort B1)
Required: NRAS mutation
p53mt/RASonc (Cohort B1)
Required: HRAS mutation
p53mt/RASonc (Cohort B1)
Required: KRAS wild-type
p53mt/RASwt CRC (Cohort B2)
Required: NRAS wild-type
p53mt/RASwt CRC (Cohort B2)
Required: HRAS wild-type
p53mt/RASwt CRC (Cohort B2)
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic antineoplastic therapy
Has received at least one prior line of therapy with progression or intolerance
Cannot have received: PARP inhibitor
Prior treatment with PARP inhibitor
Cannot have received: (FUDR)
Prior treatment with FUDR
Cannot have received: (FTD/TPI)
Prior treatment with FTD/TPI
Lab requirements
Blood counts
Hemoglobin >= 9 g/dL; Absolute neutrophil count >= 1500/mm^3; Platelet count >= 100,000/mm^3 without transfusion or growth factor support
Kidney function
Creatinine < 1.5 upper limit of normal (ULN) or creatinine clearance > 60 mL/min
Liver function
Total bilirubin < 1.5 x ULN; AST/ALT <= 2.5 x ULN or < x 5 ULN in the presence of liver metastasis; Albumin > 3 g/dL
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; AST/ALT <= 2.5 x ULN or < x 5 ULN in the presence of liver metastasis; Albumin > 3 g/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Roswell Park Cancer Institute · Buffalo, New York
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