TAS-102 and Irinotecan in 2L+ Gastric and Gastroesophageal Adenocarcinoma

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT04074343
Phase
PHASE1
Status
Completed

Conditions

  • Gastric Adenocarcinoma
  • GastroEsophageal Cancer

Eligibility Criteria

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

Interventions

  • TAS-102 — DRUG
    Given PO
  • Irinotecan — DRUG
    Given IV

Study Details

This is a phase Ib single-arm, open-label clinical trial determining the feasibility and efficacy of TAS-102 and irinotecan in subjects with advanced gastric and gastroesophageal adenocarcinoma. These are subjects who are not candidates for curative treatments and who have received at least one prior line of chemotherapy with a fluoropyrimidine and platinum agent.

Key Dates

Start date
Aug 26, 2019
Status verified
May 2023
Primary completion
Jul 14, 2021
Completion
Jul 21, 2022

Study Design

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

Arms

  • Experimental: TAS-102 and Irinotecan
    Patients receive TAS-102 25 mg/m2 PO twice daily on days 1-5 and and Irinotecan 180mg/m2 IV on day 1 every 14 days.

Primary Outcome Measure

Percentage of Participants With Progression-free Survival at 6 Months [ Time Frame: 6 Months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California, IrvineOrangeCalifornia92868-
UC Davis Comprehensive Cancer CenterSacramentoCalifornia95817-

Find similar trials in Orange, CA

By research site
Chao Family Comprehensive Cancer Center, University of California, Irvine· Orange, CAUC Davis Comprehensive Cancer Center· Sacramento, CA

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