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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: TAS-102

• Registration Number: NCT02301117
• Lead Sponsor: Taiho Oncology, Inc.

Brief Summary

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

• Study First Submitted: 2014-11-13
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-25
• Study Start: 2015-01
• Primary Completion: 2019-06-19
• Study Completion: 2019-06-19
• Status Verified: 2021-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Severe Renal Impairment	TAS-102	35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28 day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met. The dose level of severe cohort will be determined based on the Interim Assessment of mild and moderate cohorts
Mild Renal Impairment	TAS-102	35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28 day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met.
Moderate Renal Impairment	TAS-102	35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28 day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met.
Normal Renal Function	TAS-102	35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28 day cycle. Number of cycles: approximately 4 or until discontinuation criteria is met.

Primary Outcome Measures

Name	Time	Method
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
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, FTY, and TPI: Ae% and CLr. FTD and TPI: CL/F, Vd/F of TAS-102

Trial Locations

Locations (13)

Cleveland Clinical Site; 🇺🇸 Cleveland, Ohio, United States

Boston Clinical Site; 🇺🇸 Boston, Massachusetts, United States

Sremska Kamenica Clinical Site; 🇷🇸 Sremska Kamenica, Serbia

Phoenix Clinical Site; 🇺🇸 Phoenix, Arizona, United States

Santa Monica Clinical Site; 🇺🇸 Santa Monica, California, United States

Duarte Clinical Site; 🇺🇸 Duarte, California, United States

Gainesville Clinical Site; 🇺🇸 Gainesville, Florida, United States

Dallas Clinical Site; 🇺🇸 Dallas, Texas, United States

Pittsburgh Clinical Site; 🇺🇸 Pittsburgh, Pennsylvania, United States

Brno Clinical Site; 🇨🇿 Brno, Czechia

Baltimore Clinical Site; 🇺🇸 Baltimore, Maryland, United States

Praha Clinical Site; 🇨🇿 Praha, Czechia

Belgrade Clinical Site; 🇷🇸 Belgrade, Serbia