The purpose of this study is to compare the bioavailability of TAS-102 tablets to an oral solution containing equivalent amounts FTD and TPI.
This is a Phase 1, open-label, randomized, 2-sequence, 3-period crossover study evaluating the relative bioavailability of TAS-102 tablets compared to an oral solution in patients with advanced solid tumors. This study will be conducted in 2 parts. The crossover bioavailability part will be followed by an extension conducted with TAS-102 tablets only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Crossover bioavailability part: 60 mg/dose, orally, up to 2 single doses separated by 1-week washout. Extension part: 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.
60 mg/dose, orally, up to 2 single doses separated by 1-week washout
Scottsdale Healthcare
Scottsdale, Arizona, United States
Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (Cmax)
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Time frame: Day 1 of Periods 1, 2, and 3
Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (AUC0-last)
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Time frame: Day 1 of Periods 1, 2, and 3
Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (AUC0-inf )
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Time frame: Day 1 of Periods 1, 2, and 3
Tmax of FTD, TPI, and metabolites of FTD following administration of TAS 102 tablet and oral solution
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Time frame: Day 1 of Periods 1, 2, and 3
T1/2 of FTD, TPI, and metabolites of FTD following administration of TAS 102 tablet and oral solution
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Time frame: Day 1 of Periods 1, 2, and 3
CL/F of FTD and TPI following administration of TAS 102 tablet and oral solution
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Time frame: Day 1 of Periods 1, 2, and 3
Vd/F of FTD and TPI following administration of TAS 102 tablet and oral solution
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
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Time frame: Day 1 of Periods 1, 2, and 3
Cmax of metabolites of FTD following administration of TAS 102 tablet and oral solution
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Time frame: Day 1 of Periods 1, 2, and 3
AUC0-last of metabolites of FTD following administration of TAS 102 tablet and oral solution
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Time frame: Day 1 of Periods 1, 2, and 3
AUC0-inf of metabolites of FTD following administration of TAS 102 tablet and oral solution
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Time frame: Day 1 of Periods 1, 2, and 3
Safety monitoring including adverse events, vital signs, and laboratory assessments
Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.
Time frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment
Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Every 8 weeks during the extension period 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.