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

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

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Key information

Conditions

Advanced Solid Tumors Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Renal Insufficiency Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brno Clinical Site, Brno, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion

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

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

Treatment and study plan

TAS-102

Drug

Primary outcomes

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

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
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

Sponsors and collaborators

Lead sponsor

Taiho Oncology, Inc.

Industry

Registry information

Official study 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 Renal Impairment

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: Nov 25, 2014
Registry last updated: Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed