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Poly (ADP-ribose) polymerase (PARP) inhibitor
Trifluridine/Tipiracil + Talazoparib for Gastroesophageal Cancer
Phase 1
Recruiting
Led By Christos Fountzilas, MD
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Has received at least one prior line of therapy with progression or intolerance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of talazoparib when given with trifluridine/tipiracil to treat patients with locally advanced or metastatic colorectal or gastroesophageal cancer.
Who is the study for?
This trial is for adults with advanced or metastatic colorectal or gastroesophageal cancer who have tried at least one treatment without success. They must be able to perform daily activities with ease (ECOG status 0-1), have a life expectancy of more than 3 months, and meet specific blood count and organ function criteria. Pregnant women, those with certain infections like HIV or hepatitis B, or patients with other serious health conditions are excluded.Check my eligibility
What is being tested?
The study is testing the combination of two drugs: trifluridine/tipiracil and talazoparib. Trifluridine/tipiracil is a chemotherapy drug that kills cancer cells or stops them from growing. Talazoparib blocks enzymes needed by tumor cells to grow. The goal is to find the best dose of talazoparib that can be given safely with trifluridine/tipiracil.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk and bleeding problems, liver issues indicated by abnormal tests, kidney problems which might show as changes in urine output or swelling in legs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I've had treatment before but my condition got worse or I couldn't tolerate it.
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I can swallow pills.
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My cancer is advanced or has spread, confirmed by lab tests.
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My kidney function is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events
Maximum tolerated dose/ recommended phase II dose
Secondary outcome measures
CEA response rate (colorectal cancer patients)
Number of subjects with DNA damage response
Overall Response Rate (ORR)
+4 moreSide effects data
From 2021 Phase 2 trial • 28 Patients • NCT0407244596%
Anemia
67%
Neutrophil count decreased
63%
Platelet count decreased
52%
Lymphocyte count decreased
48%
White blood cell decreased
33%
Fatigue
22%
Diarrhea
15%
Nausea
15%
Alkaline phosphatase increased
15%
Hypertension
11%
Dysgeusia
11%
Biliary tract infection
7%
Dyspnea
7%
Ascites
7%
Edema limbs
7%
Blood bilirubin increased
7%
Alopecia
4%
Febrile neutropenia
4%
Intraoperative hemorrhage
4%
Respiratory failure
4%
Anorexia
4%
Non-cardiac chest pain
4%
Arthritis
4%
Gastroesophageal reflux disease
4%
Abdominal pain
4%
Arthralgia
4%
Sepsis
4%
Mucositis oral
4%
Spinal fracture
4%
Paresthesia
4%
Infections and infestations - Oth spec
4%
Aspartate aminotransferase increased
4%
Infusion related reaction
4%
Alanine aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Trifluridine and Tipiracil, Irinotecan)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment2 Interventions
Patients receive trifluridine/tipiracil PO BID and talazoparib tosylate PO QD on days 1-5. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trifluridine and Tipiracil Hydrochloride
2019
Completed Phase 2
~70
Talazoparib Tosylate
2015
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,813 Total Patients Enrolled
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,910,395 Total Patients Enrolled
Christos Fountzilas, MDPrincipal InvestigatorRoswell Park Cancer Institute
2 Previous Clinical Trials
42 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need fluid removed from my abdomen weekly or have a permanent catheter.I am fully active or can carry out light work.I've had treatment before but my condition got worse or I couldn't tolerate it.I can swallow pills.I have a condition that might affect how my body absorbs certain medications.I haven't had a GI blockage or tear in the last 4 weeks.I have previously been treated with a PARP inhibitor or FTD/TPI.I am currently receiving treatment for another cancer.I have brain involvement that hasn't been treated, or it's stable after treatment.I haven't had radiotherapy in the last 2 weeks, except for pain relief in my bones.I am currently pregnant or breastfeeding.My cancer is advanced or has spread, confirmed by lab tests.I am currently on antibiotics for an infection.I have severe side effects from previous treatments.I have HIV or hepatitis B, or I've treated my hepatitis C and now have an undetectable viral load.I have a history of blood disorders or bone marrow transplant.I have not had serious heart issues or blood clots in the last 3 months.My kidney function is within the normal range.I haven't had cancer treatment in the last 2 weeks, or 6 weeks if it was with mitomycin C or nitrosourea.My liver enzymes are within acceptable limits, even with liver metastasis.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the benefits of Trifluridine and Tipiracil Hydrochloride?
"Trifluridine and Tipiracil Hydrochloride is an effective treatment for patients that have received oxaliplatin chemotherapy, anti-vegf, and have metastatic colorectal cancer (crc)."
Answered by AI
What other research has been conducted that includes Trifluridine and Tipiracil Hydrochloride?
"Currently, 8 out of 109 Trifluridine and Tipiracil Hydrochloride clinical trials are in their final stage. The majority of research is based in Boston, yet there are nearly 3000 locations running these studies."
Answered by AI
Has the FDA cleared Trifluridine and Tipiracil Hydrochloride for use?
"Trifluridine and Tipiracil Hydrochloride's Phase 1 status limits the amount of clinical data available to support its efficacy and safety, so it was given a score of 1."
Answered by AI
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