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The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.
This is a Phase 1, open-label, randomized, parallel, 2-group study evaluating the PK of FTD as a TAS-102 component compared with FTD alone in patients with advanced solid tumors (excluding breast cancer). Patients will be randomized to receive a single dose of TAS-102 or FTD during the PK contribution phase and will receive continuing cycles of TAS-102 during the extension phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAS-102 | Experimental |
| |
| FTD (Trifluridine) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAS-102 | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| FTD pharmacokinetic parameters AUC0-last and Cmax | Day 1 of Cycle 1 |
| Measure | Description | Time Frame |
|---|---|---|
| FTD pharmacokinetic parameters AUC0-inf, Tmax, T1/2, CL/F, and Vd/F | Day 1 of Cycle 1 | |
| FTY and TPI pharmacokinetic parameters AUC0-last, Cmax, AUC0-inf, Tmax, T1/2, CL/F, and Vd/F | Day 1 of Cycle 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Drew Rasco, MD | South Texas Accelerated Research Therapeutics, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Texas Accelerated Research Therapeutics, LLC | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| C000613803 | trifluridine tipiracil drug combination |
| D014271 | Trifluridine |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Trifluridine | Drug | 35 mg/m2, orally, single dose |
|
| Multiple-dose FTD, FTY, and TPI pharmacokinetic parameters AUC0-last, Cmax, Tmax, T1/2 | Day 12 of Cycles 1, 2, and 3 |
| Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST) | 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. |
| 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. | Through 30 days following last administration of study medication or until initiation of new anticancer treatment |
| D006571 |
| Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |