CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
S-1+leucovorindrug
Likely dose
S-1+leucovorin 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03517618
NCT03517618Phase 2Completed
CompareCT.gov

A Phase II Study Assessing Efficacy and Safety of TS-1 in Combination With Calcium Folinate in Patients With Heavily Pre-treated Metastatic Colorectal Cancer

TTY Biopharm·interventional·Posted May 7, 2018·Updated May 7, 2018

In Brief

A Phase 2 clinical trial evaluating S-1+leucovorin for Metastatic Colorectal Cancer. Completed, enrolled 41 participants across 1 site.

Detailed Summary

Primary Objective: To determine disease control rate (DCR) of TS-1® in patients with heavily pre-treated metastatic colorectal cancer Secondary Objectives: * To determine objective response rate (ORR) * To determine time to progression (TTP) * To determine overall survival (OS) * To assess incidence of adverse events (AEs), serious adverse events (SAEs) \[Safety and Tolerability\]

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Colorectal Cancer
CountriesTaiwan
CollaboratorsChang Gung Memorial Hospital

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 7, 2018
Enrollment StartJul 5, 2014
Primary CompletionJun 18, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.2 years ago

Interventions

S-1+leucovorindrug

Eligible patients will receive TS-1 orally 40-60 mg (depending on patient's body surface area (BSA)) in combination with calcium folinate 30 mg twice a day for 7 days in a 2-week cycle. The treatment will be administered until disease progression, intolerable toxicity, or consent withdrawal during any time of the study.