A Phase 1 interventional study of TAS-102 tablets and TAS-102 oral solution in Advanced Solid Tumors (Excluding Breast Cancer), sponsored by Taiho Oncology, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Taiho Oncology, Inc. · Phase 1, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 46 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Taiho Oncology, Inc. is the lead sponsor of 62 studies on the registry; 8 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: TAS-102 tablets
Drug: TAS-102 oral solution
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
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.
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.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Taiho Oncology, Inc.