A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic Impairment
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 Hepatic Impairment.
1 other identifier
interventional
24
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2015
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2014
CompletedFirst Posted
Study publicly available on registry
November 25, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedSeptember 5, 2024
August 1, 2024
1.4 years
November 13, 2014
August 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 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
Safety monitoring including adverse events, vital signs, and laboratory assessments
Through 30 days following last administration of study medication or until initiation of new anticancer treatment
Study Arms (4)
Mild Hepatic Impairment
EXPERIMENTAL35 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.
Moderate Hepatic Impairment
EXPERIMENTAL35 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.
Severe Hepatic Impairment
EXPERIMENTAL35 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, if enrolled, will be determined based on the Interim Assessment of mild and moderate cohorts.
Normal Hepatic Function
EXPERIMENTAL35 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Duarte Clinical Site
Duarte, California, 91010, United States
Santa Monica Clinical Site
Santa Monica, California, 90404, United States
Baltimore Clinical Site
Baltimore, Maryland, 21231, United States
Boston Clinical Site
Boston, Massachusetts, 02111, United States
Cleveland Clinical Site
Cleveland, Ohio, 44195, United States
Pittsburgh Clinical Site
Pittsburgh, Pennsylvania, 15232, United States
Dallas Clinical Site
Dallas, Texas, 75246, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2014
First Posted
November 25, 2014
Study Start
January 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
September 5, 2024
Record last verified: 2024-08