A Phase I Study of TAS-102 in Solid Tumors

Phase 1

Completed

• Conditions: Advanced or Metastatic Solid Tumors
• Interventions: Drug: TAS-102

• Registration Number: NCT02261532
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

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 (Day1 and Day 12) of therapy in all consenting patients.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-10
• Primary Completion: 2015-10
• Study Completion: 2017-06
• Results First Submitted: 2024-08-01
• Results First Submitted QC: 2024-08-01
• Status Verified: 2024-10
• Results First Posted: 2024-10-18
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAS-102	TAS-102	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Taiho Pharmaceutical Co., Ltd selected site; 🇨🇳 Beijing, China