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NCT02025192 · ClinicalTrials.gov registry record · Phase 1

A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer

A Phase 1 study, sponsored by Seagen.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target

NCT02025192: Completed Phase 1 study, sponsored by Seagen.

NCT02025192 is a Phase 1 study that has completed, run by Seagen. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02025192, a Phase 1 study, has completed, sponsored by Seagen.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target

Study Summary

The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended phase 2 dose (RP2D) of tucatinib (ONT-380) and to assess the safety and tolerability of tucatinib (ONT-380) combined with capecitabine alone, trastuzumab alone and with both capecitabine and trastuzumab in patients with HER2+ metastatic breast cancer.

Interventions

  • DRUG Trastuzumab
  • DRUG Capecitabine
  • DRUG Tucatinib

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2013-12-31
Est. Completion 2020-03-16
Phase Phase 1
Seagen

84 total trials

What the finished NCT02025192 record still lists

NCT02025192 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.

NCT02025192 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02025192 about?

NCT02025192 is a clinical study titled "A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer". The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended phase 2 dose (RP2D) of tucatinib (ONT-380) and to assess the safety and tolerability of tucatinib (ONT-380) combined with capecitabine alone, trastuzumab alone and with both capecitabine and trastuzumab in pati...

What is the current status of trial NCT02025192?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2013-12-31. Estimated completion is 2020-03-16.

What interventions are being tested in trial NCT02025192?

The interventions under investigation include: Trastuzumab (DRUG), Capecitabine (DRUG), Tucatinib (DRUG).

Who is sponsoring clinical trial NCT02025192?

This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02025192's enrollment target sits among peer trials

60 831st of 2000 higher than 1,106 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 NCT02025192, the US trial registry maintained by the National Library of Medicine. NCT02025192 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.