Status:
COMPLETED
A Phase I Study of TAS-102 in Solid Tumors
Lead Sponsor:
Taiho Pharmaceutical Co., Ltd.
Conditions:
Advanced or Metastatic Solid Tumors
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to evaluate the pharmacokinetics of TAS-102 after single and multiple dose in Chinese patients with solid tumor.
Detailed Description
This is an open-label, non-randomized, single group Phase 1 study of TAS-102, evaluating the pharmacokinetics, safety, and antitumor activity. Blood sampling will be performed during the first cycle (...
Eligibility Criteria
Inclusion
- 1\. Has provided written informed consent prior to performance of any study procedure.
- 2\. Has definitive histologically or cytologically confirmed advanced or metastatic solid tumor.
- 3\. Is able to take medications orally.
- 4\. Has adequate organ function (bone marrow, kidney and liver).
- 5\. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1.
Exclusion
- 1\. Has received TAS-102.
- 2\. Has suffered serious complications.
- 3\. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies.
- 4\. Has had prior gastrectomy.
- 5\. Is a pregnant or lactating female or male who refused using birth control during the clinical trial period and within 6 months after discontinuation of study treatment.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02261532
Start Date
September 1 2014
End Date
June 1 2017
Last Update
November 14 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Taiho Pharmaceutical Co., Ltd selected site
Beijing, China