Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion

Description

Summary

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

Official 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 Renal Impairment

Details

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 renal 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.

Keywords

Advanced Solid Tumors Renal Kidney Diseases Urologic Diseases Renal Insufficiency Renal Impairment Pharmacokinetics Advance Solid Tumor Creatinine Clearance Kidney Neoplasms Renal Tumor Kidney Urology Pharmacologic Action TAS-102 Mild Renal Impairment Moderate Renal Impairment Severe Renal Impairment

Eligibility

For people ages 18 years and up

Inclusion

  1. Has provided written informed consent
  2. Has advanced solid tumors (excluding breast cancer)
  3. Has normal renal function, mild, moderate, or severe renal impairment and is not on dialysis
  4. ECOG performance status of ≤2
  5. Is able to take medications orally
  6. Has adequate organ function
  7. 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

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

Locations

  • Santa Monica Clinical Site accepting new patients
    Santa Monica California 90095 United States
  • Duarte Clinical Site accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Taiho Oncology, Inc.
ID
NCT02301117
Phase
Phase 1
Study Type
Interventional
Last Updated