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NCT02031055 · ClinicalTrials.gov registry record · Phase 1

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 of Advanced Solid Tumors, sponsored by Taiho Oncology.

Completed
Registry status
Phase 1
Development phase
8
Enrollment target
1
Study location

NCT02031055: Completed Phase 1 study of Advanced Solid Tumors, sponsored by Taiho Oncology.

NCT02031055 is a Phase 1 study of Advanced Solid Tumors that has completed, run by Taiho Oncology. The registered enrollment target is 8 participants, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02031055, a Phase 1 study of Advanced Solid Tumors, has completed, sponsored by Taiho Oncology.

COMPLETED
Registry status
Phase 1
Development phase
8 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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.

Conditions Studied

Interventions

  • DRUG TAS-102 with a light tracer dose of [14C]FTD
  • DRUG TAS-102 with a light tracer dose of [14C] TPI
  • DRUG TAS-102 tablets

Study Locations (1)

Pennsylvania

  • University of Pittsbutgh Cancer Institute - Pittsburgh

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2014-02
Est. Completion 2015-06-17
Phase Phase 1
Taiho Oncology

52 total trials

What the finished NCT02031055 record still lists

NCT02031055 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 199-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 3 interventions - of which TAS-102 with a light tracer dose of [14C]FTD is the first listed.

NCT02031055 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT02031055 about?

NCT02031055 is a clinical study titled "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.

What is the current status of trial NCT02031055?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2014-02. Estimated completion is 2015-06-17.

What conditions does trial NCT02031055 study?

This clinical trial studies the following conditions: Advanced Solid Tumors.

What interventions are being tested in trial NCT02031055?

The interventions under investigation include: TAS-102 with a light tracer dose of [14C]FTD (DRUG), TAS-102 with a light tracer dose of [14C] TPI (DRUG), TAS-102 tablets (DRUG).

Who is sponsoring clinical trial NCT02031055?

This trial is sponsored by Taiho Oncology, which has 52 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02031055 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Advanced Solid Tumors

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02031055's enrollment target sits among peer trials

8 142nd of 144 higher than 3 of 144 other Advanced Solid Tumors trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02031055, the US trial registry maintained by the National Library of Medicine. NCT02031055 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.