Actively Recruiting
Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer
Led by Roswell Park Cancer Institute · Updated on 2026-05-04
45
Participants Needed
1
Research Sites
407 weeks
Total Duration
On this page
Sponsors
R
Roswell Park Cancer Institute
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed colorectal or gastroesophageal adenocarcinoma that is locally advanced or metastatic
- Patients with p53 mutant/RAS oncogenic or wildtype colorectal cancer allowed
- At least one prior line of therapy with progression or intolerance
- Measurable disease according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of 3 months or more
- Hemoglobin level of 9 g/dL or higher
- Absolute neutrophil count of 1500/mm³ or higher
- Platelet count of 100,000/mm³ or higher without transfusion or growth factor support
- Creatinine less than 1.5 times upper limit of normal or creatinine clearance over 60 mL/min
- Total bilirubin less than 1.5 times upper limit of normal
- AST/ALT less than or equal to 2.5 times upper limit of normal or less than 5 times with liver metastasis
- Albumin greater than 3 g/dL
- Ability to swallow oral medications
- Participants able to use effective contraception if of child-bearing potential
- Signed informed consent and understanding of study nature
You will not qualify if you...
- Received systemic antineoplastic therapy within 2 weeks before study start (or 6 weeks if mitomycin C or nitrosourea)
- Radiotherapy within 2 weeks prior to study except palliative treatment to bone lesions
- Prior treatment with PARP inhibitors, FUDR, or trifluridine/tipiracil
- Conditions limiting absorption of study drugs from gastrointestinal tract
- Gastrointestinal obstruction or perforation within 4 weeks before study start
- Refractory ascites requiring frequent paracentesis or permanent catheter
- Untreated central nervous system disease or leptomeningeal disease
- Significant recent cardiac events or severe heart failure
- Other active cancers requiring treatment
- Toxicities from prior therapy of grade 2 or higher
- Active infections needing antibiotics
- Known HIV or hepatitis B infection or untreated hepatitis C
- History of myelodysplastic syndrome, acute leukemia, or bone marrow transplant
- Pregnant or breastfeeding females
- Unwilling or unable to follow study protocol
- Any condition making participant unsuitable for study treatment as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
Research Team
S
Sarah Chatley, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here