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

August 30, 2024 updated by: Taiho Oncology, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia
        • Brno Clinical Site
      • Praha, Czechia
        • Praha Clinical Site
  • Serbia
      • Belgrade, Serbia, 11080
        • Belgrade Clinical Site
      • Sremska Kamenica, Serbia, 21204
        • Sremska Kamenica Clinical Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Phoenix Clinical Site
    • California
      • Duarte, California, United States, 91010
        • Duarte Clinical Site
      • Santa Monica, California, United States, 90095
        • Santa Monica Clinical Site
    • Florida
      • Gainesville, Florida, United States, 32610
        • Gainesville Clinical Site
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Baltimore Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Boston Clinical Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinical Site
      • Cleveland, Ohio, United States, 44106
        • Cleveland Clinical Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Pittsburgh Clinical Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Dallas Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mild Renal Impairment
35 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.
Drug: TAS-102
Experimental: Moderate Renal Impairment
35 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.
Drug: TAS-102
Experimental: Severe Renal Impairment

35 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
Drug: TAS-102
Experimental: Normal Renal Function
35 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.
Drug: TAS-102

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through 30 days following last administration of study medication or until initiation of new anticancer treatment
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, FTY, and TPI: Ae% and CLr. FTD and TPI: CL/F, Vd/F of TAS-102
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiho Oncology, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

June 19, 2019

Study Completion (Actual)

June 19, 2019

Study Registration Dates

First Submitted

November 13, 2014

First Submitted That Met QC Criteria

November 21, 2014

First Posted (Estimated)

November 25, 2014

Study Record Updates

Last Update Posted (Actual)

September 5, 2024

Last Update Submitted That Met QC Criteria

August 30, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TO-TAS-102-107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Solid Tumors

Clinical Trials on TAS-102

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Azerbaijan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe