NCT03517618

TS-1 in Combination With Calcium Folinate in Patients With Heavily Pre-treated mCRC

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: TTY Biopharm · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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) \[Safety and Tolerability\]

Detailed description

Simon's optimal two-stage design will be used to determine the sample size for this study. • Stage I: \>1/9: The first 9 evaluable patients enrolled, \>1 (or ≥2) responders are required in order to enter the second stage, otherwise the trial will be terminated at the first stage due to futility. • Stage II: Total \>8/34: For the total 34 evaluable patients, \>8 (or ≥9) responders are required to conclude the effectiveness of the study regimen. The primary endpoint will be disease control rate which will be presented in frequency tabulation with two-sided 95% confidence interval (using binomial estimation). The secondary endpoints are described as follows: * ORR will be presented in frequency tabulation with two-sided 95% confidence interval; * TTP will be estimated by Kaplan-Meier method with two-sided 95% confidence interval; * OS will be estimated by Kaplan-Meier method with two-sided 95% confidence interval; * Incidence of adverse events (AEs), serious adverse events (SAEs) \[Safety and Tolerability\] : assessed by CTCAE v4.0. Safety parameters will only be analyzed on the safety analysis set and be presented in frequency tabulation.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	S-1+leucovorin	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.

Timeline

• Start date: 2014-07-05
• Primary completion: 2015-06-18
• Completion: 2015-06-18
• First posted: 2018-05-07
• Last updated: 2018-05-07

Locations

1 site across 1 country: Taiwan