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NCT02154529 · ClinicalTrials.gov registry record · Phase 1

Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer

A Phase 1 study, sponsored by Kadmon Corporation.

Terminated
Registry status
Phase 1
Development phase
17
Enrollment target

NCT02154529: Clinical Trial Phase 1 study, sponsored by Kadmon Corporation.

NCT02154529 is a Phase 1 study that was terminated before completion, run by Kadmon Corporation. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02154529, a Phase 1 study, was terminated before completion, sponsored by Kadmon Corporation.

TERMINATED
Registry status
Phase 1
Development phase
17 participants
Enrollment target

Study Summary

Evaluate the safety and tolerability and determine the maximum tolerated dose (MTD) of the combination of tesevatinib and trastuzumab in subjects with HER2-positive metastatic breast cancer

Primary Outcome

Percentage of subjects with at least 1 treatment-emergent adverse event of Grade 3 or greater or relationship with tesevatinib. TEAE grading was by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) where Grade 3 is severe and Grade 4 is life-threatening. TEAEs were considered related to study drug if the investigator assessed them as possibly related, probably related, or related.

Interventions

  • DRUG Trastuzumab
  • DRUG Tesevatinib

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2014-05
Est. Completion 2015-09-13
Phase Phase 1
Kadmon Corporation

15 total trials

Why NCT02154529 stopped before completion

NCT02154529 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).

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

NCT02154529 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02154529 about?

NCT02154529 is a clinical study titled "Study of the Combination of KD019 and Trastuzumab in Subjects With HER2-Positive Metastatic Breast Cancer". Evaluate the safety and tolerability and determine the maximum tolerated dose (MTD) of the combination of tesevatinib and trastuzumab in subjects with HER2-positive metastatic breast cancer

What is the current status of trial NCT02154529?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2014-05. Estimated completion is 2015-09-13.

What interventions are being tested in trial NCT02154529?

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

Who is sponsoring clinical trial NCT02154529?

This trial is sponsored by Kadmon Corporation, which has 15 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02154529's enrollment target sits among peer trials

17 1785th of 2000 higher than 215 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 NCT02154529, the US trial registry maintained by the National Library of Medicine. NCT02154529 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.