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Completed

NCT Number: NCT01610479

A Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors

This is a phase 1 study of TAS-114 in combination with S-1 in patients with advanced solid tumors.

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Key information

Conditions

Advanced Solid Tumors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site 01

Kashiwanoha, Kashiwa-shi, Chiba, 277-8577, Japan

About this study

This is a phase 1, open-label, non-randomized, dose-escalating safety, tolerability, and pharmacokinetic study of TAS-114 in combination with S-1 in patients with advanced solid tumors.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Life expectancy of at least 3 months
  • Histological or cytological documentation of advanced solid tumors
  • ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group)
  • Adequate bone marrow, liver and renal function
  • Women of childbearing potential and men must agree to use adequate contraception

Treatment and study plan

TAS-114 + S-1

Drug

Primary outcomes

  1. Maximum tolerated dose of TAS-114 when used in combination with S-1

    Time frame: 4 years

Secondary outcomes

  1. Pharmacokinetic profiles (peak plasma concentration (Cmax) and area under the plasma concentration versus time curve (AUC) of TAS-114, S-1 components and its metabolite)

    Time frame: 4 years

  2. Response rate

    Time frame: 4 years

  3. Disease control rate

    Time frame: 4 years

  4. Progression free survival

    Time frame: 4 years

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Taiho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 1 Study of TAS-114 in Combination With S-1 in Patients With Advanced Solid Tumors

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jun 4, 2012
Registry last updated
Aug 4, 2017

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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