Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer
A Phase I Study of Trifluridine/ Tipiracil Plus the Poly (ADP) Ribose Polymerase Inhibitor Talazoparib in Advanced Cancers
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the side effects and best dose of talazoparib when taken with the chemotherapy drug trifluridine/tipiracil. It is for people with cancer of the colon, rectum, stomach, or food pipe that has spread to nearby tissues, lymph nodes, or other parts of the body.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have adenocarcinoma, a cancer that starts in gland cells, confirmed by tissue or cell testing. Some study groups also require certain gene changes.
- Have tried at least one cancer treatment that stopped working or caused side effects you could not tolerate.
- Have cancer that can be measured on scans.
- Be fully active or able to do light work, and be expected to live at least 3 months.
- Have blood counts and kidney and liver test results that meet the study's limits.
- Be able to swallow pills.
- Agree to use birth control if you could become pregnant. Tell your doctor right away about a possible pregnancy during the study.
- Understand the study and sign a consent form before any study procedures.
Who can't join
- Had cancer drug treatment too recently—usually within 2 weeks, or 6 weeks for certain drugs—or radiation within 2 weeks. Radiation to ease painful bone cancer is allowed. Past treatment with a PARP blocker, FUDR, or trifluridine/tipiracil is not allowed.
- Have trouble absorbing the study drugs, a recent hole or blockage in the gut without a bypass, or belly fluid that needs draining at least weekly or through a permanent tube.
- Have untreated cancer in the brain or spinal cord, or cancer in their lining. Treated cancer in the brain or spinal cord must be stable for at least 4 weeks.
- Have serious heart disease, or a recent heart event, stroke, blood clot, or abnormal rhythm in the heart's lower chambers.
- Have another cancer needing treatment, or ongoing moderate or worse side effects from past treatment.
- Have an infection needing antibiotics, HIV, hepatitis B, or untreated hepatitis C. Treated hepatitis C is allowed if the virus cannot be detected.
- Have ever had myelodysplastic syndrome, a disorder that affects blood cell production, acute leukemia, or a bone marrow transplant.
- Are pregnant or breastfeeding, cannot or will not follow study rules, or have another condition the study doctor thinks makes treatment unsuitable.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
NY
- Roswell Park Cancer Institute · Buffalo, NY 14263Christos Fountzilas, MD · Study contactMore trials in Buffalo