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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Taiho Oncology, Inc.
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.
ClinicalTrials.gov Identifier:
NCT02301117
First received: November 13, 2014
Last updated: September 5, 2017
Last verified: September 2017
  Purpose
Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of renal impairment.

Condition Intervention Phase
Advanced Solid Tumors Drug: TAS-102 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Taiho Oncology, Inc.:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 48
Study Start Date: January 2015
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02301117

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

Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02301117     History of Changes
Other Study ID Numbers: TO-TAS-102-107
Study First Received: November 13, 2014
Last Updated: September 5, 2017

Keywords provided by Taiho Oncology, Inc.:
Renal
Kidney Diseases
Renal Insufficiency
Renal Impairment
Advance Solid Tumor
Kidney Neoplasms
Renal Tumor
Kidney
Urologic Diseases
Pharmacokinetics
Creatinine Clearance
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

ClinicalTrials.gov processed this record on September 19, 2017