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

Advanced Solid Tumors Clinical Trial

Official 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 Hepatic Impairment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02301104
• Other study ID #: TO-TAS-102-106
• Status: Completed
• Phase: Phase 1
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2020
• Source: Taiho Oncology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 hepatic 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion

1. Has provided written informed consent

2. Has advanced solid tumors (excluding breast cancer)

3. Has normal hepatic function, mild, moderate, or severe hepatic impairment

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, shunt in the liver 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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• TAS-102

Locations

Country	Name	City	State
United States	Baltimore Clinical Site	Baltimore	Maryland
United States	Boston Clinical Site	Boston	Massachusetts
United States	Cleveland Clinical Site	Cleveland	Ohio
United States	Dallas Clinical Site	Dallas	Texas
United States	Duarte Clinical Site	Duarte	California
United States	Pittsburgh Clinical Site	Pittsburgh	Pennsylvania
United States	Santa Monica Clinical Site	Santa Monica	California
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Oncology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 and TPI: CL/F, Vd/F 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
Primary	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