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Trifluridine/Tipiracil and Talazoparib for Advanced Colorectal or Gastroesophageal Cancer

This study is looking at the safety and best dose of two drugs, trifluridine/tipiracil and talazoparib, when given together for people with colorectal (bowel) or gastroesophageal (food pipe and stomach) cancer that has spread. Trifluridine/tipiracil works by stopping cancer cells from growing and dividing. Talazoparib may also stop cancer growth by blocking certain enzymes (proteins that speed up chemical reactions) needed by the cells. The study wants to see if combining these drugs can better stop tumor growth. You might be able to join if you have advanced colorectal or gastroesophageal adenocarcinoma. The main goal is to find out what side effects happen and the highest dose that can be given safely.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 45 participants to find the safest and most effective dose.
What's involved
The primary endpoints measure adverse events after each treatment cycle (1 cycle = 14 days) and the maximum tolerated dose within 14 days.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured after each treatment cycle and up to 14 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04511039

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Roswell Park Cancer Institute
~45 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Trifluridine and Tipiracil HydrochlorideTalazoparib Tosylate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events
Measured over after each cycle of treatment ( 1 cycle = 14 days)
+1 more outcome measured

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

Explore related trials

Colorectal CarcinomaGastroesophageal Junction Adenocarcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Christos Fountzilas, MD · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

Sarah Chatley, BS
[email protected]
716-845-4846
Email the study team

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Eligibility criteria

Inclusion

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 (ALT) =\< 2.5 x ULN or \< x 5 ULN in the presence of liver metastasis
Albumin \> 3 g/dL
Ability to swallow oral medications
Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion

Systemic antineoplastic therapy within 2 weeks prior to day -14 (Dose Escalation, Cohort A) or Cycle 1 day 1 (Dose Expansion, Cohorts B1 and B2) or within the past 6 weeks if this treatment is mitomycin C or nitrosourea
Radiotherapy within the past 2 weeks excluding palliative radiotherapy to painful bone lesions
Prior treatment with PARP inhibitor, FUDR or FTD/TPI
Any condition that in the investigator's opinion can limit absorption of FTD/TPI or talazoparib from the gastrointestinal (GI) tract
Gastrointestinal obstruction (without diversion) or perforation within 4 weeks from initiation of day -14 (Dose Escalation, Cohort A) or Cycle 1 Day 1 (Dose Expansion, Cohorts B1 and B2.
Refractory ascites (requiring weekly or more frequent paracentesis or permanent indwelling peritoneal catheter)
Untreated central nervous system (CNS) disease. Patients with leptomeningeal disease are ineligible but patients with treated, stable CNS metastasis for at least 4 weeks are allowed to participate
Significant cardiac disease defined as congestive heart failure stage III or IV (New York Heart Association \[NYHA\]), acute coronary event, cerebrovascular event, peripheral arterial embolic event, venous thromboembolic event (pulmonary embolism or lower extremity deep vein thrombosis), or ventricular arrhythmia within the past 3 months
Other malignancy requiring active therapy
Presence of toxicities from prior therapy of grade 2 or higher
Active infection requiring antibiotic therapy
Known human immunodeficiency virus (HIV) or hepatitis B infection or untreated hepatitis C infection. Patients with treated hepatitis C infection and undetectable viral load are allowed to participate
Any history of myelodysplastic syndrome, acute leukemia, or bone marrow transplant
Pregnant or nursing female participants
Unwilling or unable to follow protocol requirements
Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

What this trial measures

  • Incidence of Adverse Eventsafter each cycle of treatment ( 1 cycle = 14 days)

    All adverse events will be evaluated using Common Terminology Criteria for All Adverse Events (CTCAE) version (v.) 5.

  • Maximum tolerated dose/ recommended phase II doseUp to 14 days

    Will utilize the keyboard design - a novel model- assisted dose-finding method to find the maximum tolerated dose