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Advanced Solid TumorsPhase 1NCT02031055

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

A Phase 1 study testing TAS-102 with a light tracer dose of [14C]FTD, TAS-102 with a light tracer dose of [14C] TPI and TAS-102 tablets in people with Advanced Solid Tumors, run by Taiho Oncology, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
TAS-102 with a light tracer dose of [14C]FTD, TAS-102 with a light tracer dose of [14C] TPI and TAS-102 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Feb 2014to 17 Jun 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Pittsbutgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
TAS-102 with a light tracer dose of [14C]FTD, TAS-102 with a light tracer dose of [14C] TPI, TAS-102 tablets
Keywords
Advanced solid tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Oral Solution

    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)

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

    Also called Oral solution

    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)

  • TAS-102 tabletsDrug

    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).

Study groups in NCT02031055
Study groupRoleWhat they receive
TAS-102 with light tracer dose of [14C]FTDExperimentalNot described
Receives: Drug: TAS-102 with a light tracer dose of [14C]FTD; Drug: TAS-102 tablets
TAS-102 with light tracer dose of [14C]TPIExperimentalNot described
Receives: Drug: TAS-102 with a light tracer dose of [14C] TPI; Drug: TAS-102 tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Day 1 through day 8 (through 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

    Measured: 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

    Characterization of FTD and TPI metabolites

    Measured: 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.

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

    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

    Measured: 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 (2)

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

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

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

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

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionNov 2014
  4. Study completion17 Jun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02031055
Sponsor's protocol ID
TPU-TAS-102-108
Status last verified
Aug 2024
First submitted
18 Dec 2013
Last updated
5 Sep 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAS-102 with a light tracer dose of [14C]FTD, TAS-102 with a light tracer dose of [14C] TPI and TAS-102 tablets in people with Advanced Solid Tumors, run by Taiho Oncology, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02031055.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.

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