A Phase I Study of TAS-102 in Solid Tumors

Taiho Pharmaceutical Co., Ltd.15 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced or Metastatic Solid Tumors

Interventions

TAS-102DRUG

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

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Taiho Pharmaceutical Co., Ltd selected site

Beijing, China

Outcomes

Primary Outcomes

Cmax (Maximum Plasma Concentration) of FTD

Time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.

Tmax (Time to Reach Maximum Drug Concentration in Blood) of FTD

Time frame: 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

Time frame: Multiple time points on Day 1 and Day 12 of Cycle 1.

Data from ClinicalTrials.gov

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