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

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.

Study Overview

• Status: Completed
• Conditions: Advanced or Metastatic Solid Tumors
• Intervention / Treatment: Drug: TAS-102

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 Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Taiho Pharmaceutical Co., Ltd selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAS-102	Drug: TAS-102; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax (maximum plasma concentration) of FTD and TPI	Multiple time points on Day 1 and Day 12 of Cycle 1.
Tmax (time to reach maximum drug concentration in blood) of FTD and TPI	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 and TPI	Multiple time points on Day 1 and Day 12 of Cycle 1.
AUC0-10 (area under the plasma concentration versus time curve from time 0 to 10 hours post dose) of FTD and TPI	Multiple time points on Day 1 and Day 12 of Cycle 1.
AUCinf (area under the plasma concentration versus time curve from time 0 to infinity) of FTD and TPI	Multiple time points on Day 1 and Day 12 of Cycle 1.
T½ (half-life) of FTD and TPI	Multiple time points on Day 1 and Day 12 of Cycle 1.
CL/F (oral clearance) of FTD and TPI	Multiple time points on Day 1 and Day 12 of Cycle 1.
Vd/F (apparent volume of distribution) of FTD and TPI	Multiple time points on Day 1 and Day 12 of Cycle 1.

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events as a measure of safety	Through 30 days following last administration of study medication.
Antitumor Activity (Response Rate)	Average 8 weeks from Cycle 1 Day 1.

Collaborators and Investigators

• Sponsor: Taiho Pharmaceutical Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: October 6, 2014
• First Posted (Estimate): October 10, 2014

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: August 2, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 10040100