A Phase 1, Open-label, Randomized, Crossover Study Evaluating the Bioavailability of TAS-102 Tablets Relative to an Oral Solution Containing Equivalent Amounts of FTD and TPI
18 Years
N/A
Both
Advanced Solid Tumors (Excluding Breast Cancer)
Trial Information
A Phase 1, Open-label, Randomized, Crossover Study Evaluating the Bioavailability of TAS-102 Tablets Relative to an Oral Solution Containing Equivalent Amounts of 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.
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (Cmax)
Outcome Description:
Pharmacokinetic samples are taken on Day 1 of Periods 1, 2, and 3.
Outcome Time Frame:
Day 1 of Periods 1, 2, and 3
Safety Issue:
No
Principal Investigator
Daniel Von Hoff, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Scottsdale Healthcare
Authority:
United States: Food and Drug Administration
Study ID:
TPU-TAS-102-104
NCT ID:
NCT01874522
Start Date:
July 2013
Completion Date:
June 2014
Related Keywords:
- Advanced Solid Tumors (Excluding Breast Cancer)
- Advanced solid tumors (excluding breast cancer) for which no standard therapy exists
- Breast Neoplasms
Name | Location |
|---|---|
| Scottsdale Healthcare | Scottsdale, Arizona 85251 |
