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

NCT03517618 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2018-05-07

No results posted yet for this study

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) \[Safety and Tolerability\]

Conditions

Interventions

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • TTY Biopharm

    lead INDUSTRY

Principal Investigators

  • Hung-Chih Hsu · Chang Gung Memorial Hospital, Linkou, Taiwan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-05
Primary Completion
2015-06-18
Completion
2015-06-18

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03517618 on ClinicalTrials.gov