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NCT02134067 · ClinicalTrials.gov registry record · Phase 1

Dose-escalating, Safety, Tolerability and PK Study of TAS-119 in Combination With Paclitaxel in Patients With Advanced Solid Tumors

A Phase 1 study, sponsored by Taiho Oncology.

Terminated
Registry status
Phase 1
Development phase
30
Enrollment target

NCT02134067: Clinical Trial Phase 1 study, sponsored by Taiho Oncology.

NCT02134067 is a Phase 1 study that was terminated before completion, run by Taiho Oncology. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02134067, a Phase 1 study, was terminated before completion, sponsored by Taiho Oncology.

TERMINATED
Registry status
Phase 1
Development phase
30 participants
Enrollment target

Study Summary

The purpose of this study is to determine the safety of TAS-119 and determine the most appropriate dose in combination with Paclitaxel for subsequent studies in patients with advanced solid tumors. TAS-119 is a novel, selective Aurora A kinase inhibitor, which has previously been demonstrated to enhance the activity of paclitaxel in preclinical studies

Primary Outcome

Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 will be used. The safety and tolerability of TAS-119 will be evaluated by the number and severity of adverse events, vital signs, physical exam, and clinical laboratory assessments.

Interventions

  • DRUG Paclitaxel
  • DRUG TAS-119

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2014-08
Est. Completion 2018-07
Phase Phase 1
Taiho Oncology

52 total trials

Why NCT02134067 stopped before completion

NCT02134067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).

The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.

NCT02134067 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02134067 about?

NCT02134067 is a clinical study titled "Dose-escalating, Safety, Tolerability and PK Study of TAS-119 in Combination With Paclitaxel in Patients With Advanced Solid Tumors". The purpose of this study is to determine the safety of TAS-119 and determine the most appropriate dose in combination with Paclitaxel for subsequent studies in patients with advanced solid tumors. TAS-119 is a novel, selective Aurora A kinase inhibitor, which has previously been demonstrated to en...

What is the current status of trial NCT02134067?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2014-08. Estimated completion is 2018-07.

What interventions are being tested in trial NCT02134067?

The interventions under investigation include: Paclitaxel (DRUG), TAS-119 (DRUG).

Who is sponsoring clinical trial NCT02134067?

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

How this trial's enrollment target compares

Where NCT02134067's enrollment target sits among peer trials

30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT02134067, the US trial registry maintained by the National Library of Medicine. NCT02134067 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.