A Phase I Study of TAS-102 in Solid Tumors

Taiho Pharma

Status and phase

Completed

Phase 1

Conditions

Advanced or Metastatic Solid Tumors

Treatments

Drug: TAS-102

Study type

Interventional

Funder types

Industry

Identifiers

NCT02261532

10040100

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Has provided written informed consent prior to performance of any study procedure.
1. Has definitive histologically or cytologically confirmed advanced or metastatic solid tumor.
1. Is able to take medications orally.
1. Has adequate organ function (bone marrow, kidney and liver).
1. Has Eastern Cooperative Group (ECOG) performance status of 0 or 1.

Exclusion criteria

1. Has received TAS-102.
1. Has suffered serious complications.
1. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies.
1. Has had prior gastrectomy.
1. 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.