Recruiting nowPhase 1
What this trial is trying to do
The researchers think that adding talazoparib, a drug that blocks PARP enzymes involved in DNA repair, to trifluridine/tipiracil chemotherapy may make it harder for cancer cells to survive. This phase I trial is testing the combination’s side effects and the dose of talazoparib that can be given safely in locally advanced or metastatic colorectal or gastroesophageal cancer.
Because there is no comparison group, the trial is not designed to show whether the combination helps people live longer or delays tumour growth. Its immediate measure of improvement is finding a dose and schedule that can be given with acceptable side effects, with any signs of tumour control being secondary or exploratory.
Worth knowing: This is a small, non-randomised early-phase trial, so it is primarily testing safety rather than whether the treatment works.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT04511039 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | not randomised, open label |
| Taking part | 45 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Roswell Park Cancer Institute |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Trifluridine and Tipiracil Hydrochloride
- Drug Talazoparib Tosylate
What it is measuring
Incidence of Adverse Events
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
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.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 1 site. Listed in: United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT04511039, registered by Roswell Park Cancer Institute on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.