Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer

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.

Conditions

• Advanced Malignant Solid Neoplasm
• Clinical Stage III Gastroesophageal Junction Adenocarcinoma
• Clinical Stage IV Gastroesophageal Junction Adenocarcinoma
• Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma
• Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma A
• Locally Advanced Colorectal Carcinoma
• Locally Advanced Gastroesophageal Junction Adenocarcinoma
• Metastatic Colorectal Adenocarcinoma
• Metastatic Gastroesophageal Junction Adenocarcinoma
• Pathologic Stage III Gastroesophageal Junction Adenocarcinoma
• Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma
• Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma
• Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma
• Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma
• Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma
• Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
• Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
• Stage III Colorectal Cancer AJCC v8
• Stage IIIA Colorectal Cancer AJCC v8
• Stage IIIB Colorectal Cancer AJCC v8
• Stage IIIC Colorectal Cancer AJCC v8
• Stage IV Colorectal Cancer AJCC v8
• Stage IVA Colorectal Cancer AJCC v8
• Stage IVB Colorectal Cancer AJCC v8
• Stage IVC Colorectal Cancer AJCC v8

Interventions

DRUG

Trifluridine and Tipiracil Hydrochloride

Given PO

DRUG

Talazoparib Tosylate

Given PO

Sponsors & Collaborators

• Pfizer

  collaborator INDUSTRY

• National Cancer Institute (NCI)

  collaborator NIH

• Roswell Park Cancer Institute

  lead OTHER

Principal Investigators

• Christos Fountzilas, MD · Roswell Park Cancer Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-08

Primary Completion

2028-09-01

Completion

2029-04-01

FDA Drug

Yes

Countries

• United States

Study Locations