Clinical trial NCT02301104: A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic 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 Hepatic Impairment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Liver Neoplasms
Hepatic
TAS-102
mCRC
Liver Impairment
Pharmacologic Actions
Liver Diseases
Liver
LFT
Advanced Solid Tumor
Pharmacokinetics
Lead sponsor: Taiho Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 hepatic 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.

Eligibility criteria: Inclusion

1. Has provided written informed consent
2. Has advanced solid tumors (excluding breast cancer)
3. Has normal hepatic function, mild, moderate, or severe hepatic impairment
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, shunt in the liver 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

Primary outcomes:
measure: PK parameters of FTD, FTY, and TPI in plasma after a single dose of TAS-102
timeFrame: 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
measure: Safety monitoring including adverse events, vital signs, and laboratory assessments
timeFrame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Duarte
country: United States
facility: Duarte Clinical Site
state: California
city: Santa Monica
country: United States
facility: Santa Monica Clinical Site
state: California
city: Baltimore
country: United States
facility: Baltimore Clinical Site
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Site
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinical Site
state: Ohio
city: Pittsburgh
country: United States
facility: Pittsburgh Clinical Site
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Clinical Site
state: Texas
Study officials:
References: