NCT04511039 Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer
| NCT ID | NCT04511039 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Roswell Park Cancer Institute |
| Condition | Advanced Malignant Solid Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2021-06-08 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 45 participants in total. It began in 2021-06-08 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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 Criteria: * 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
Contact & Investigator
Christos Fountzilas, MD
PRINCIPAL INVESTIGATOR
Roswell Park Cancer Institute
Frequently Asked Questions
Who can join the NCT04511039 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Malignant Solid Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04511039 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04511039 currently recruiting?
Yes, NCT04511039 is actively recruiting participants. Contact the research team at Sarah.Chatley@roswellpark.org for enrollment information.
Where is the NCT04511039 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT04511039 clinical trial?
NCT04511039 is sponsored by Roswell Park Cancer Institute. The principal investigator is Christos Fountzilas, MD at Roswell Park Cancer Institute. The trial plans to enroll 45 participants.