Clinical Trials /

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

NCT02301117

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With 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

Clinical Trial IDs

  • ORG STUDY ID: TO-TAS-102-107
  • NCT ID: NCT02301117

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
TAS-102Mild Renal Impairment

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Mild Renal ImpairmentExperimental35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28 day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met.
  • TAS-102
Moderate Renal ImpairmentExperimental35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28 day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met.
  • TAS-102
Severe Renal ImpairmentExperimental35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28 day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met. The dose level of severe cohort will be determined based on the Interim Assessment of mild and moderate cohorts
  • TAS-102
Normal Renal FunctionExperimental35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28 day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met.
  • TAS-102

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:FTD, FTY and TPI: pharmacokinetic parameters Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2. FTD, FTY, and TPI: Ae% and CLr. FTD and TPI: CL/F, Vd/F of TAS-102

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Taiho Oncology, Inc.

Trial Keywords

  • Renal
  • Kidney Diseases
  • Urologic Diseases
  • Renal Insufficiency
  • Renal Impairment
  • Pharmacokinetics
  • Advance Solid Tumor
  • Creatinine Clearance
  • Kidney Neoplasms
  • Renal Tumor
  • Kidney
  • Urology
  • Pharmacologic Action

Last Updated

August 29, 2016