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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAS-102 tablets | Experimental |
| |
| TAS-102 oral solution | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAS-102 tablets | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Day 1 of Periods 1, 2, and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Von Hoff, MD | Scottsdale Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale Healthcare | Scottsdale | Arizona | 85258 | United States |
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| ID | Term |
|---|---|
| C000613803 | trifluridine tipiracil drug combination |
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|
| TAS-102 oral solution | Drug | 60 mg/dose, orally, up to 2 single doses separated by 1-week washout |
|
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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) | 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. |