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NCT Number: NCT02301104

A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic Impairment

Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of hepatic impairment.

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Key information

Conditions

Advanced Solid Tumors Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mayo Clinic, Scottsdale, Arizona, United States

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About this study

This is a Phase 1, open-label study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors with varying degrees of hepatic impairment. The study is conducted in 2 parts: the Pharmacokinetic Part (Cycle 1) and the Extension Part (Cycles 2 and beyond). Patients may continue to receive treatment with TAS-102 during the study extension part only after completion of the Pharmacokinetic Part.

Who can participate

Healthy volunteers accepted: No

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

Inclusion

  • Has provided written informed consent
  • Has advanced solid tumors (excluding breast cancer)
  • Has normal hepatic function, mild, moderate, or severe hepatic impairment
  • ECOG performance status of ≤2
  • Is able to take medications orally
  • Has adequate organ function
  • Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion

  • Certain serious illnesses or medical condition(s)
  • Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, shunt in the liver within the specified time frames prior to study drug administration
  • Has received TAS-102
  • Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
  • Is a pregnant or lactating female

Treatment and study plan

TAS-102

Drug

Primary outcomes

  1. PK parameters of FTD, FTY, and TPI in plasma after a single dose of TAS-102

    Time frame: Blood samples will be collected in Cycle 1 Day 1 and Day 12 at pre-dose, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours post AM dose of TAS-102

    FTD, FTY and TPI: pharmacokinetic parameters Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2. FTD and TPI: CL/F, Vd/F of TAS-102

  2. Safety monitoring including adverse events, vital signs, and laboratory assessments

    Time frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment

Sponsors and collaborators

Lead sponsor

Taiho Oncology, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAS-102 in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Impairment.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 25, 2014
Registry last updated
Sep 5, 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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