Advanced Solid Tumors
Conditions
Keywords
Liver Neoplasms, Hepatic, TAS-102, mCRC, Liver Impairment, Pharmacologic Actions, Liver Diseases, Liver, LFT, Advanced Solid Tumor, Pharmacokinetics
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.
Interventions
DRUGTAS-102
Sponsors
Taiho Oncology, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK parameters of FTD, FTY, and TPI in plasma after a single dose 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 | 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 |
| 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 | — |
Countries
United States
Outcome results
None listed