Status:
COMPLETED
A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment
Lead Sponsor:
Taiho Oncology, Inc.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2019
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02301117
Start Date
January 1 2015
End Date
June 19 2019
Last Update
September 5 2024
Active Locations (14)
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1
Phoenix Clinical Site
Phoenix, Arizona, United States, 85054
2
Duarte Clinical Site
Duarte, California, United States, 91010
3
Santa Monica Clinical Site
Santa Monica, California, United States, 90095
4
Gainesville Clinical Site
Gainesville, Florida, United States, 32610