A Phase I Study of TAS-102 in Solid Tumors
A Phase 1, OPEN-Label, Non-randomized, Pharmacokinetic Study of TAS-102 in Chinese Patients With Solid Tumors
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2014
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 30, 2014
CompletedFirst Posted
Study publicly available on registry
October 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedResults Posted
Study results publicly available
October 18, 2024
CompletedNovember 14, 2024
October 1, 2024
1.1 years
September 30, 2014
August 1, 2024
October 29, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Cmax (Maximum Plasma Concentration) of FTD
Multiple time points on Day 1 and Day 12 of Cycle 1.
Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD
Multiple time points on Day 1 and Day 12 of Cycle 1.
AUC0-t (Area Under the Plasma Concentration Versus Time Curve From Time 0 to Time (t) of the Last Quantifiable Concentration ) of FTD
Multiple time points on Day 1 and Day 12 of Cycle 1.
Study Arms (1)
TAS-102
EXPERIMENTALInterventions
TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
Eligibility Criteria
You may qualify if:
- \. Has provided written informed consent prior to performance of any study procedure.
- \. Has definitive histologically or cytologically confirmed advanced or metastatic solid tumor.
- \. Is able to take medications orally.
- \. Has adequate organ function (bone marrow, kidney and liver).
- \. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1.
You may not qualify if:
- \. Has received TAS-102.
- \. Has suffered serious complications.
- \. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies.
- \. Has had prior gastrectomy.
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taiho Pharmaceutical Co., Ltd selected site
Beijing, China
Related Publications (1)
Wang X, Zhou J, Li Y, Ge Y, Zhou Y, Bai C, Shen L. Pharmacokinetics, Safety, and Preliminary Efficacy of Oral Trifluridine/Tipiracil in Chinese Patients with Solid Tumors: A Phase 1b, Open-Label Study. Clin Pharmacol. 2020 Apr 9;12:21-33. doi: 10.2147/CPAA.S232104. eCollection 2020.
PMID: 32308505DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Clinical Trial Registration Contact
- Organization
- Taiho Pharmaceutical co., ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2014
First Posted
October 10, 2014
Study Start
September 1, 2014
Primary Completion
October 1, 2015
Study Completion
June 1, 2017
Last Updated
November 14, 2024
Results First Posted
October 18, 2024
Record last verified: 2024-10