Advanced Solid Tumors (Excluding Breast Cancer)
Conditions
Keywords
Advanced solid tumors (excluding breast cancer) for which no standard therapy exists
Brief summary
The purpose of this study is to compare the bioavailability of TAS-102 tablets to an oral solution containing equivalent amounts FTD and TPI.
Detailed description
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.
Interventions
DRUGTAS-102 tablets
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.
DRUGTAS-102 oral solution
60 mg/dose, orally, up to 2 single doses separated by 1-week washout
Sponsors
Taiho Oncology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Has provided written informed consent 2. Has advanced solid tumors (excluding breast cancer) for which no standard therapy exists 3. ECOG performance status of 0 or 1 4. Is able to take medications orally 5. Has adequate organ function (bone marrow, kidney and liver) 6. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.
Exclusion criteria
1. Has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration 2. Certain serious illnesses or medical condition(s) 3. Has had either partial or total gastrectomy 4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies 5. Known sensitivity to TAS-102 or its components 6. Is a pregnant or lactating female 7. Refuses to use an adequate means of contraception (including male patients)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (Cmax) | Day 1 of Periods 1, 2, and 3 | Pharmacokinetic samples are taken on 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) | Day 1 of Periods 1, 2, and 3 | Pharmacokinetic samples are taken on 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 ) | Day 1 of Periods 1, 2, and 3 | Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vd/F of FTD and TPI following administration of TAS 102 tablet and oral solution | Day 1 of Periods 1, 2, and 3 | Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3. |
| Cmax of metabolites of FTD following administration of TAS 102 tablet and oral solution | Day 1 of Periods 1, 2, and 3 | Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3. |
| AUC0-last of metabolites of FTD following administration of TAS 102 tablet and oral solution | Day 1 of Periods 1, 2, and 3 | Pharmacokinetic samples are taken on 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 | Day 1 of Periods 1, 2, and 3 | Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3. |
| Safety monitoring including adverse events, vital signs, and laboratory assessments | 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) | 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. | — |
| AUC0-inf of metabolites of FTD following administration of TAS 102 tablet and oral solution | Day 1 of Periods 1, 2, and 3 | Pharmacokinetic samples are taken on 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 | Day 1 of Periods 1, 2, and 3 | Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3. |
| CL/F of FTD and TPI following administration of TAS 102 tablet and oral solution | Day 1 of Periods 1, 2, and 3 | Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3. |
Countries
United States
Outcome results
None listed