Actively Recruiting
A Phase I Study of Trifluridine/Tipiracil Plus the Poly (ADP) Ribose Polymerase Inhibitor Talazoparib in Advanced Colorectal or Gastroesophageal Cancer
Led by Roswell Park Cancer Institute · Updated on 2026-05-04
45
Participants Needed
1
Research Sites
30 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
Researchers are evaluating the safety, best dose, and effects of combining the drugs talazoparib and trifluridine/tipiracil in patients with locally advanced or metastatic colorectal or gastroesophageal cancer. This phase I trial aims to determine the maximum tolerated dose and recommended dose for further studies, while also assessing how the drugs behave in the body and their preliminary effectiveness against tumor growth. Participants receive trifluridine/tipiracil by mouth twice daily and talazoparib by mouth once daily on days 1 through 5 of each cycle. Each treatment cycle lasts 14 days and repeats as long as the cancer does not progress and side effects remain manageable. The study focuses on evaluating the combination of these two oral chemotherapy drugs to inhibit tumor cell growth enzymes. During the study, participants will be regularly monitored for side effects after each 14-day cycle. Researchers will measure drug levels in the blood, track tumor response, progression-free survival, and overall survival for up to three years. Safety assessments will include monitoring adverse events and blood markers related to DNA damage. Participants are expected to continue treatment unless disease progression or unacceptable toxicity occurs.
CONDITIONS
Brief 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 mutated/RAS oncogenic or wild-type colorectal cancer in specified cohorts
- Received at least one prior line of therapy with progression or intolerance
- Measurable disease per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Hemoglobin level of 9 g/dL or higher
- Absolute neutrophil count of at least 1500/mm^3
- Platelet count of at least 100,000/mm^3 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 level greater than 3 g/dL
- Ability to swallow oral medications
- Use of adequate contraceptive methods for participants of child-bearing potential
- Signed informed consent form prior to any study procedures
You will not qualify if you...
- Systemic antineoplastic therapy within 2 weeks prior to study start or within 6 weeks if mitomycin C or nitrosourea
- Radiotherapy within 2 weeks prior, except for palliative treatment to bone lesions
- Prior treatment with PARP inhibitors, FUDR, or FTD/TPI
- Any condition limiting absorption of study drugs from the gastrointestinal tract
- Gastrointestinal obstruction or perforation within 4 weeks prior to study start
- Refractory ascites requiring frequent paracentesis or permanent catheter
- Untreated central nervous system disease or leptomeningeal disease
- Significant cardiac disease within the past 3 months
- Other malignancies requiring active therapy
- Toxicities from prior therapy of grade 2 or higher
- Active infection requiring antibiotics
- Known HIV or hepatitis B infection, or untreated hepatitis C infection
- History of myelodysplastic syndrome, acute leukemia, or bone marrow transplant
- Pregnant or nursing females
- Unwilling or unable to follow protocol requirements
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 14-day cycles until disease progression or discontinuation
Participants receive trifluridine/tipiracil twice daily and talazoparib once daily on days 1 to 5 of each 14-day cycle until disease progression or unacceptable toxicity.
Visits every 14 days corresponding to each treatment cycle
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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