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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02301117
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : June 16, 2021
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

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)
Actual Enrollment : 43 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
Actual Study Start Date : January 2015
Actual Primary Completion Date : June 19, 2019
Actual Study Completion Date : June 19, 2019
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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301117


Locations
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United States, Arizona
Phoenix Clinical Site
Phoenix, Arizona, United States, 85054
United States, California
Duarte Clinical Site
Duarte, California, United States, 91010
Santa Monica Clinical Site
Santa Monica, California, United States, 90095
United States, Florida
Gainesville Clinical Site
Gainesville, Florida, United States, 32610
United States, Maryland
Baltimore Clinical Site
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Boston Clinical Site
Boston, Massachusetts, United States, 02111
United States, Ohio
Cleveland Clinical Site
Cleveland, Ohio, United States, 44106
Cleveland Clinical Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Pittsburgh Clinical Site
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Dallas Clinical Site
Dallas, Texas, United States, 75246
Czechia
Brno Clinical Site
Brno, Czechia
Praha Clinical Site
Praha, Czechia
Serbia
Belgrade Clinical Site
Belgrade, Serbia, 11080
Sremska Kamenica Clinical Site
Sremska Kamenica, Serbia, 21204
Sponsors and Collaborators
Taiho Oncology, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02301117    
Other Study ID Numbers: TO-TAS-102-107
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: June 16, 2021
Last Verified: June 2021
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:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases