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Completed

NCT Number: NCT02261532

A Phase I Study of TAS-102 in 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.

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Key information

Conditions

Advanced or Metastatic Solid Tumors

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Taiho Pharmaceutical Co., Ltd selected site

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TAS-102

Drug

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.

Primary outcomes

  1. Cmax (Maximum Plasma Concentration) of FTD

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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 1, OPEN-Label, Non-randomized, Pharmacokinetic Study of TAS-102 in Chinese Patients With Solid Tumors

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Oct 10, 2014
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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