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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Advanced Solid Tumors	Drug: TAS-102	Phase 1

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	48 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Renal Impairment
Study Start Date :	January 2015
Estimated Primary Completion Date :	November 2017
Estimated Study Completion Date :	November 2017

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Mild Renal Impairment; 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.	Drug: TAS-102
Experimental: Moderate Renal Impairment; 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.	Drug: TAS-102
Experimental: Severe Renal Impairment; 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	Drug: TAS-102
Experimental: Normal Renal Function; 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.	Drug: TAS-102

Outcome Measures

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Primary Outcome Measures :

1. 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
2. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Robert Winkler, MD	609-750-5300	rwinkler@taihooncology.com
Contact: Taiho Oncology, Inc	855-598-8259

Locations

United States, Arizona
Phoenix Clinical Site	Completed
Phoenix, Arizona, United States, 85054
United States, California
Duarte Clinical Site	Recruiting
Duarte, California, United States, 91010
Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com
Santa Monica Clinical Site	Recruiting
Santa Monica, California, United States, 90095
Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com
United States, Florida
Gainesville Clinical Site	Recruiting
Gainesville, Florida, United States, 32610
Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com
United States, Maryland
Baltimore Clinical Site	Active, not recruiting
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Boston Clinical Site	Recruiting
Boston, Massachusetts, United States, 02111
Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com
United States, Ohio
Cleveland Clinical Site	Completed
Cleveland, Ohio, United States, 44106
Cleveland Clinical Site	Completed
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pittsburgh Clinical Site	Completed
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Dallas Clinical Site	Recruiting
Dallas, Texas, United States, 75246
Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com
Czechia
Brno Clinical Site	Recruiting
Brno, Czechia
Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com
Praha Clinical Site	Recruiting
Praha, Czechia
Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com
Serbia
Belgrade Clinical Site	Recruiting
Belgrade, Serbia, 11080
Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com
Sremska Kamenica Clinical Site	Recruiting
Sremska Kamenica, Serbia, 21204
Contact: Robert Winkler, MD 855-598-8259 rwinkler@taihooncology.com

Sponsors and Collaborators

Taiho Oncology, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Taiho Oncology, Inc.
ClinicalTrials.gov Identifier:	NCT02301117 History of Changes
Other Study ID Numbers:	TO-TAS-102-107
First Posted:	November 25, 2014
Last Update Posted:	September 6, 2017
Last Verified:	September 2017

Keywords provided by Taiho Oncology, Inc.:

Renal; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Impairment; Pharmacokinetics; Advance Solid Tumor	Creatinine Clearance; Kidney Neoplasms; Renal Tumor; Kidney; Urology; Pharmacologic Action

Additional relevant MeSH terms:

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Trifluridine	Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents