Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-05 @ 12:37 AM
Study NCT ID:
NCT03517618
Status:
COMPLETED
Last Update Posted:
2018-05-07
First Post:
2018-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TS-1 in Combination With Calcium Folinate in Patients With Heavily Pre-treated mCRC
Sponsor:
TTY Biopharm
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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) \[Safety and Tolerability\]
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.
• 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: