CompletedPhase 1

A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment

United States43 participantsStarted 2015-01

Plain-language summary

Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of renal impairment.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

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

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

Trial details

NCT IDNCT02301117

SponsorTaiho Oncology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06-19

View on ClinicalTrials.gov More Advanced Solid Tumors trials