Study to Evaluate the Cardiac Safety of TAS-102 in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01867879|
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : November 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors (Excluding Breast Cancer)||Drug: TAS-102 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Phase 1 Study to Evaluate the Cardiac Safety of Orally Administered TAS-102 in Patients With Advanced Solid Tumors|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||April 2015|
35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
|Placebo Comparator: Placebo||
Placebo tablets, orally, single dose.
- QTc interval [ Time Frame: Days -2, -1, 1, and 12 of Cycle 1 ]Predose (Day -2) to post-dose changes and absolute values in QTc interval after placebo (Day -1, Cycle 1), after a single dose of TAS-102 (Day 1, Cycle 1), and after multiple doses (Day 12, Cycle 1)
- Quantitative and Qualitative ECG parameters [ Time Frame: Days -2, -1, 1, and 12 of Cycle 1 ]Predose (Day -2) to postdose changes and absolute values in quantitative Holter ECG parameters (heart rate, RR, PR and QRS intervals) after placebo (Day -1, Cycle 1), after a single dose of TAS-102 (Day 1, Cycle 1), and after multiple doses (Day 12, Cycle 1). In addition, qualitative assessments of Holter ECG recordings will be performed.
- Relationship between TAS-102 pharmacokinetics and its effect on cardiac repolarization [ Time Frame: Days 1 and 12 of Cycle 1 ]Pharmacokinetic samples are taken on Days 1 and 12 of Cycle 1. The relationship between plasma concentrations of TAS-102 and the change from baseline in QTc adjusted by placebo will be quantified using a linear mixed effect model approach.
- 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 ]Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.
- Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Every 8 weeks through Cycle 6 (ie, through 24 weeks). Thereafter, assessments will be performed at least every 12 weeks according to site standard of care, until at least one of the treatment discontinuation criteria is met. ]
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): NCT01867879
|United States, Tennessee|
|Sarah Cannon Research Institute|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Johanna Bendell, MD||SCRI Development Innovations, LLC|