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Status:

COMPLETED

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

Lead Sponsor:

Taiho Oncology, Inc.

Conditions:

Advanced Solid Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

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

Detailed Description

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 i...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2015

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2016

    Estimated Enrollment :

    24 Patients enrolled

    Trial Details

    Trial ID

    NCT02301104

    Start Date

    January 1 2015

    End Date

    June 1 2016

    Last Update

    September 5 2024

    Active Locations (8)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    1

    Mayo Clinic

    Scottsdale, Arizona, United States, 85259

    2

    Duarte Clinical Site

    Duarte, California, United States, 91010

    3

    Santa Monica Clinical Site

    Santa Monica, California, United States, 90404

    4

    Baltimore Clinical Site

    Baltimore, Maryland, United States, 21231