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

Primary Purpose

Advanced Solid Tumors

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TAS-102
Sponsored by
Taiho Oncology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumors focused on measuring Renal, Kidney Diseases, Urologic Diseases, Renal Insufficiency, Renal Impairment, Pharmacokinetics, Advance Solid Tumor, Creatinine Clearance, Kidney Neoplasms, Renal Tumor, Kidney, Urology, Pharmacologic Action

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix Clinical Site
  • Duarte Clinical Site
  • Santa Monica Clinical Site
  • Gainesville Clinical Site
  • Baltimore Clinical Site
  • Boston Clinical Site
  • Cleveland Clinical Site
  • Cleveland Clinical Site
  • Pittsburgh Clinical Site
  • Dallas Clinical Site
  • Brno Clinical Site
  • Praha Clinical Site
  • Belgrade Clinical Site
  • Sremska Kamenica Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Mild Renal Impairment

Moderate Renal Impairment

Severe Renal Impairment

Normal Renal Function

Arm Description

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.

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.

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

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.

Outcomes

Primary Outcome Measures

PK parameters of FTD, FTY, and TPI in plasma after a single 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
Safety monitoring including adverse events, vital signs, and laboratory assessments

Secondary Outcome Measures

Full Information

First Posted
November 13, 2014
Last Updated
June 15, 2021
Sponsor
Taiho Oncology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02301117
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
June 19, 2019 (Actual)
Study Completion Date
June 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Oncology, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors
Keywords
Renal, Kidney Diseases, Urologic Diseases, Renal Insufficiency, Renal Impairment, Pharmacokinetics, Advance Solid Tumor, Creatinine Clearance, Kidney Neoplasms, Renal Tumor, Kidney, Urology, Pharmacologic Action

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mild Renal Impairment
Arm Type
Experimental
Arm Description
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.
Arm Title
Moderate Renal Impairment
Arm Type
Experimental
Arm Description
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.
Arm Title
Severe Renal Impairment
Arm Type
Experimental
Arm Description
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
Arm Title
Normal Renal Function
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TAS-102
Primary Outcome Measure Information:
Title
PK parameters of FTD, FTY, and TPI in plasma after a single dose of TAS-102
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
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Has provided written informed consent Has advanced solid tumors (excluding breast cancer) Has normal renal function, mild, moderate, or severe renal impairment and is not on dialysis 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, 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
Facility Information:
Facility Name
Phoenix Clinical Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Duarte Clinical Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Santa Monica Clinical Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Gainesville Clinical Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Baltimore Clinical Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Boston Clinical Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Cleveland Clinical Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinical Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Pittsburgh Clinical Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Dallas Clinical Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Brno Clinical Site
City
Brno
Country
Czechia
Facility Name
Praha Clinical Site
City
Praha
Country
Czechia
Facility Name
Belgrade Clinical Site
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
Sremska Kamenica Clinical Site
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia

12. IPD Sharing Statement

Citations:
PubMed Identifier
34097100
Citation
Saif MW, Becerra CR, Fakih MG, Sun W, Popovic L, Krishnamurthi S, George TJ, Rudek MA, Shepard DR, Skopek J, Sramek V, Zaric B, Yamamiya I, Benhadji KA, Hamada K, He Y, Rosen L. A phase I, open-label study evaluating the safety and pharmacokinetics of trifluridine/tipiracil in patients with advanced solid tumors and varying degrees of renal impairment. Cancer Chemother Pharmacol. 2021 Sep;88(3):485-497. doi: 10.1007/s00280-021-04308-z. Epub 2021 Jun 7.
Results Reference
derived

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

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