Study of Cabozantinib Plus TAS102 in mCRC as Salvage Therapy

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT04868773
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Oral cabozantinib
  • TAS-102 — DRUG
    Oral TAS-102 (trifluridine and tipiracil)

Study Details

This is a phase I clinical trial assessing the safety and recommended phase II dose of cabozantinib in combination with trifluridine/tipiracil (TAS102) in patients with metastatic colorectal carcinoma (mCRC).

Key Dates

Start date
Jul 16, 2021
Status verified
Apr 2026
Primary completion
Aug 29, 2023
Completion
Apr 9, 2024

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib in Combination with TAS-102 (trifluridine/tipiracil)
    Subjects will receive cabozantinib in combination with TAS-102. Patients will receive cabozantinib on Days 1 - 28 and TAS-102 on Days 1-5 and Days 8-12, for a cycle length of 28 days.

Primary Outcome Measure

Dose Limiting Toxicity [DLT] [ Time Frame: From the start date of treatment until 4 weeks after the last patient has started treatment, an average of 1 year. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California, IrvineOrangeCalifornia92868-

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