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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT04511039
Phase
PHASE1
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trifluridine and Tipiracil Hydrochloride — DRUG
    Given PO
  • Talazoparib Tosylate — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jun 8, 2021
Status verified
Apr 2026
Primary completion
Sep 1, 2028
Completion
Apr 1, 2029

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    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.

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: after each cycle of treatment ( 1 cycle = 14 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Christos Fountzilas, MD

Find similar trials in Buffalo, NY

By research site
Roswell Park Cancer Institute· Buffalo, NY

Related Studies