Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.
Full description
This is a Phase 1, open-label, randomized, parallel, 2-group study evaluating the PK of FTD as a TAS-102 component compared with FTD alone in patients with advanced solid tumors (excluding breast cancer). Patients will be randomized to receive a single dose of TAS-102 or FTD during the PK contribution phase and will receive continuing cycles of TAS-102 during the extension phase.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Has provided written informed consent
- Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists
- ECOG performance status of 0 or 1
- Is able to take medications orally
- Has adequate organ function (bone marrow, kidney and liver)
- 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 criteria
- Has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
- Certain serious illnesses or medical condition(s)
- Has had either partial or total gastrectomy
- Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
- Known sensitivity to TAS-102 or its components
- Is a pregnant or lactating female
- Refuses to use an adequate means of contraception (including male patients)
Trial design
Primary purpose
Allocation
Interventional model
Masking
44 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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