A Phase I Study of TAS-102 in Solid Tumors

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.
• Treatments: Trifluridine

Criteria

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.