Clinical trial NCT01867866: Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone
Official title: A Phase 1, Open-Label, Randomized, Parallel Group Study Evaluating the Pharmacokinetics of FTD as a Component of TAS-102 Compared With FTD Alone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Advanced solid tumors (excluding breast cancer) for which no standard therapy exists
Lead sponsor: Taiho Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the pharmacokinetics of trifluorothymidine (FTD) as a component of TAS-102 with FTD alone.

Detailed description: 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.

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: FTD pharmacokinetic parameters AUC0-last and Cmax
timeFrame: Day 1 of Cycle 1
Secondary outcomes:
measure: FTD pharmacokinetic parameters AUC0-inf, Tmax, T1/2, CL/F, and Vd/F
timeFrame: Day 1 of Cycle 1
measure: FTY and TPI pharmacokinetic parameters AUC0-last, Cmax, AUC0-inf, Tmax, T1/2, CL/F, and Vd/F
timeFrame: Day 1 of Cycle 1
measure: Multiple-dose FTD, FTY, and TPI pharmacokinetic parameters AUC0-last, Cmax, Tmax, T1/2
timeFrame: Day 12 of Cycles 1, 2, and 3
measure: Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 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.
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
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics, LLC
state: Texas
Study officials:
affiliation: South Texas Accelerated Research Therapeutics, LLC
name: Drew Rasco, MD
role: PRINCIPAL_INVESTIGATOR
References: