Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic 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: NCT02301104
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
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 hepatic 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 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 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 Hepatic Impairment.
Study Start Date : January 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Mild Hepatic 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 Hepatic 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 Hepatic 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, if enrolled, will be determined based on the Interim Assessment of mild and moderate cohorts.

Drug: TAS-102
Experimental: Normal Hepatic 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



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 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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 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

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): NCT02301104


Locations
Layout table for location information
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
Duarte Clinical Site
Duarte, California, United States, 91010
Santa Monica Clinical Site
Santa Monica, California, United States, 90404
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, 44195
United States, Pennsylvania
Pittsburgh Clinical Site
Pittsburgh, Pennsylvania, United States, 15232
United States, Texas
Dallas Clinical Site
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Taiho Oncology, Inc.

Layout table for additonal information
Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02301104     History of Changes
Other Study ID Numbers: TO-TAS-102-106
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Keywords provided by Taiho Oncology, Inc.:
Liver Neoplasms
Hepatic
TAS-102
mCRC
Liver Impairment
Pharmacologic Actions
Liver Diseases
Liver
LFT
Advanced Solid Tumor
Pharmacokinetics
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms