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Completed

NCT Number: NCT02031055

Study of the Mass Balance of Oral FTD and TPI as Components of TAS-102 in Patients With Advanced Solid Tumors

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Pittsbutgh Cancer Institute

Pittsburgh, Pennsylvania, 15232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has advanced solid tumors (excluding previously treated breast cancer) for which no standard therapy exists
  • ECOG performance status of 0 or 1
  • Is able to take medications orally
  • Has adequate organ function (bone marrow, kidney and liver)
  • 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

  • Has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
  • Certain serious illnesses or medical condition(s)
  • Has had either partial or total gastrectomy
  • Has a medical condition that jeopardizes or impairs ability to collect representative excreta
  • Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
  • Known sensitivity to TAS-102 or its components
  • Is a pregnant or lactating female
  • Refuses to use an adequate means of contraception (including male patients)
  • Is an occupationally exposed worker as defined by relevant ionizing radiation regulations
  • Has been exposed to 14C in the last 12 months

Treatment and study plan

TAS-102 with a light tracer dose of [14C]FTD

Drug

A single dose of 60 mg TAS-102 with a light tracer dose (200 nCi, approximately 1.2 μg) of [14C]FTD administered as an oral solution on Day 1 (mass balance part)

Other names: Oral Solution

TAS-102 with a light tracer dose of [14C] TPI

Drug

A single dose of 60 mg TAS-102 with a light tracer dose (1000 nCi, approximately 5.6 μg) of [14C]TPI administered as an oral solution on Day 1 (mass balance part)

Other names: Oral solution

TAS-102 tablets

Drug

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. Treatment starts during study extension part (day 9 of the study).

Primary outcomes

  1. Urinary, fecal, and respiratory excretion of 14C from FTD and urinary and fecal excretion of 14C from TPI

    Time frame: Day 1 through day 8 (through 168 hours postdose)

    Urine and feces samples will be collected at 24-hour intervals through 168 hours postdose. For [14C]FTD only, samples of CO2 will be trapped from expired air 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.

  2. 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

    Time frame: 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

  3. Metabolic profile of FTD and TPI in plasma, urine, and feces

    Time frame: 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.

    Characterization of FTD and TPI metabolites

  4. PK parameters of FTD, FTY, and TPI in plasma (Cmax, Tmax, AUC0-last, AUC0-inf, T1/2, CL/F, and Vd/F)

    Time frame: 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.

    Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2 will be calculated for each analyte, and CL/F and Vd/F will be calculated for FTD and TPI

Secondary outcomes

  1. Safety monitoring including adverse events, vital signs, and laboratory assessments

    Time frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment, whichever comes first

    Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used

  2. Tumor assessments using Response Evaluation Criteria in Solid Tumors (RECIST)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Taiho Oncology, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Jan 9, 2014
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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