Clinical trial NCT01874522: Study Comparing the Bioavailability of TAS-102 Tablets to an Oral Solution Containing Equivalent Amounts of FTD and TPI
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors (Excluding Breast Cancer)
Keywords: Advanced solid tumors (excluding breast cancer) for which no standard therapy exists
Lead sponsor: Taiho Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-11
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (Cmax)
timeFrame: Day 1 of Periods 1, 2, and 3
measure: Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (AUC0-last)
timeFrame: Day 1 of Periods 1, 2, and 3
measure: Extent of absorption of FTD and TPI following oral administration of TAS 102 tablets or oral solution (AUC0-inf )
timeFrame: Day 1 of Periods 1, 2, and 3
Secondary outcomes:
measure: Tmax of FTD, TPI, and metabolites of FTD following administration of TAS 102 tablet and oral solution
timeFrame: Day 1 of Periods 1, 2, and 3
measure: T1/2 of FTD, TPI, and metabolites of FTD following administration of TAS 102 tablet and oral solution
timeFrame: Day 1 of Periods 1, 2, and 3
measure: CL/F of FTD and TPI following administration of TAS 102 tablet and oral solution
timeFrame: Day 1 of Periods 1, 2, and 3
measure: Vd/F of FTD and TPI following administration of TAS 102 tablet and oral solution
timeFrame: Day 1 of Periods 1, 2, and 3
measure: Cmax of metabolites of FTD following administration of TAS 102 tablet and oral solution
timeFrame: Day 1 of Periods 1, 2, and 3
measure: AUC0-last of metabolites of FTD following administration of TAS 102 tablet and oral solution
timeFrame: Day 1 of Periods 1, 2, and 3
measure: AUC0-inf of metabolites of FTD following administration of TAS 102 tablet and oral solution
timeFrame: Day 1 of Periods 1, 2, and 3
measure: Safety monitoring including adverse events, vital signs, and laboratory assessments
timeFrame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment
measure: Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 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.
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
Study officials:
affiliation: Scottsdale Healthcare
name: Daniel Von Hoff, MD
role: PRINCIPAL_INVESTIGATOR
References: