Clinical trial NCT02031055: Study of the Mass Balance of Oral FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors
Official title: A Phase 1, Open-label Study to Evaluate the Mass Balance of Orally Administered FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Advanced solid tumors
Lead sponsor: Taiho Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate, in patients with advanced solid tumors, the mass balance of FTD and TPI after a single dose of TAS-102 with a light tracer dose of \[14C\]FTD or \[14C\]TPI.

Detailed description: This is a Phase 1, open-label study evaluating the mass balance of FTD and TPI after a single dose of TAS-102 with a light tracer dose of \[14C\]FTD or \[14C\]TPI. The study will be conducted in 2 parts: mass balance part and TAS-102 extension part. After completion of the mass balance part, patients will receive continued treatment with TAS-102 during the study extension part.

Eligibility criteria: Inclusion Criteria:

1. Has advanced solid tumors (excluding previously treated breast cancer) for which no standard therapy exists
2. ECOG performance status of 0 or 1
3. Is able to take medications orally
4. Has adequate organ function (bone marrow, kidney and liver)
5. 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 a medical condition that jeopardizes or impairs ability to collect representative excreta
5. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
6. Known sensitivity to TAS-102 or its components
7. Is a pregnant or lactating female
8. Refuses to use an adequate means of contraception (including male patients)
9. Is an occupationally exposed worker as defined by relevant ionizing radiation regulations
10. Has been exposed to 14C in the last 12 months

Primary outcomes:
measure: Urinary, fecal, and respiratory excretion of 14C from FTD and urinary and fecal excretion of 14C from TPI
timeFrame: Day 1 through day 8 (through 168 hours postdose)
measure: PK parameters of total radioactivity (AUC0-inf, AUC0-last, Cmax, Tmax, and T1/2) in whole blood and plasma after a single dose of TAS-102
timeFrame: Blood will be collected immediately prior to dosing (0 hour) and at 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose
measure: Metabolic profile of FTD and TPI in plasma, urine, and feces
timeFrame: Blood will be collected immediately prior to dosing (0 hour) and at 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose. Urine and feces samples will be collected at 24-hour intervals through 168 hours postdose.
measure: PK parameters of FTD, FTY, and TPI in plasma (Cmax, Tmax, AUC0-last, AUC0-inf, T1/2, CL/F, and Vd/F)
timeFrame: Blood will be collected immediately prior to dosing (0 hour) and at 30 minutes, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours postdose.
Secondary outcomes:
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, whichever comes first
measure: Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: Every 8 weeks during the extension phase through Cycle 6 (through 24 weeks) and at least every 12 weeks thereafter, until treatment discontinuation (ie, due to disease progression, AEs, patient death, physician decision, pregnancy, or patient request)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsbutgh Cancer Institute
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jan H Beumer, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: