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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

Must not have

Refractory ascites (requiring weekly or more frequent paracentesis or permanent indwelling peritoneal catheter)

Prior treatment with PARP inhibitor or FTD/TPI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need fluid removed from my abdomen weekly or have a permanent catheter.

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I have previously been treated with a PARP inhibitor or FTD/TPI.

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I am currently receiving treatment for another cancer.

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I haven't had radiotherapy in the last 2 weeks, except for pain relief in my bones.

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I am currently pregnant or breastfeeding.

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I am currently on antibiotics for an infection.

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I have severe side effects from previous treatments.

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I have a history of blood disorders or bone marrow transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events

Maximum tolerated dose/ recommended phase II dose

Secondary study objectives

CEA response rate (colorectal cancer patients)

Number of subjects with DNA damage response

Overall Response Rate (ORR)

+3 more

Side effects data

From 2021 Phase 2 trial • 28 Patients • NCT04072445

96%

Anemia

67%

Neutrophil count decreased

63%

Platelet count decreased

52%

Lymphocyte count decreased

48%

White blood cell decreased

33%

Fatigue

22%

Diarrhea

15%

Alkaline phosphatase increased

15%

Nausea

15%

Hypertension

11%

Biliary tract infection

11%

Dysgeusia

Dyspnea

Alopecia

Blood bilirubin increased

Ascites

Edema limbs

Non-cardiac chest pain

Paresthesia

Anorexia

Arthritis

Infusion related reaction

Spinal fracture

Gastroesophageal reflux disease

Mucositis oral

Abdominal pain

Infections and infestations - Oth spec

Intraoperative hemorrhage

Respiratory failure

Sepsis

Alanine aminotransferase increased

Febrile neutropenia

Aspartate aminotransferase increased

Arthralgia

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Trifluridine and Tipiracil, Irinotecan)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~180

Talazoparib Tosylate

2020

Completed Phase 2

~100