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

Taiho Oncology, Inc.43 enrolled

Overview

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

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 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumors

Interventions

TAS-102DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion 1. Has provided written informed consent 2. Has advanced solid tumors (excluding breast cancer) 3. Has normal renal function, mild, moderate, or severe renal impairment and is not on dialysis 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, 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

Locations (14)

Phoenix Clinical Site

Phoenix, Arizona, United States

Duarte Clinical Site

Duarte, California, United States

Santa Monica Clinical Site

Santa Monica, California, United States

Outcomes

Primary Outcomes

PK parameters of FTD, FTY, and TPI in plasma after a single dose of TAS-102

FTD, FTY and TPI: pharmacokinetic parameters Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2. FTD, FTY, and TPI: Ae% and CLr. FTD and TPI: CL/F, Vd/F of TAS-102

Time frame: 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

Time frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment

Data from ClinicalTrials.gov

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