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NCT00567879 · ClinicalTrials.gov registry record · Phase 1

A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer (MBC) Whose Disease Has Progressed on or After Trastuzumab

A Phase 1 study, sponsored by Novartis Pharmaceuticals.

Terminated
Registry status
Phase 1
Development phase
56
Enrollment target

NCT00567879: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.

NCT00567879 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 56 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

NCT00567879, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.

TERMINATED
Registry status
Phase 1
Development phase
56 participants
Enrollment target

Study Summary

The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer

Primary Outcome

Safety data was reviewed to determine the DLTs. DLTs comprised adverse events (AEs) or abnormal laboratory values that occurred at any time and were assessed as clinically relevant and meeting any of the following criteria: considered to be related to the study treatment and unrelated to disease, disease progression, inter-current illness, or concomitant medications. Toxicities were assessed using the National Cancer Institute common terminology criteria for adverse events (NCI CTCAE), version 3

Interventions

  • DRUG Trastuzumab
  • DRUG Panobinostat

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2008-04
Est. Completion 2011-05
Phase Phase 1
Novartis Pharmaceuticals

1,375 total trials

Why NCT00567879 stopped before completion

NCT00567879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 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 2 interventions - of which Trastuzumab is the first listed.

NCT00567879 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00567879 about?

NCT00567879 is a clinical study titled "A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer (MBC) Whose Disease Has Progressed on or After Trastuzumab". The primary purpose of this study is to identify the maximum tolerated dose (MTD) of both intravenous and oral panobinostat plus trastuzumab. The study will evaluate safety and efficacy of the combination in adult female patients with HER2+ metastatic breast cancer

What is the current status of trial NCT00567879?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2008-04. Estimated completion is 2011-05.

What interventions are being tested in trial NCT00567879?

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

Who is sponsoring clinical trial NCT00567879?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00567879's enrollment target sits among peer trials

56 902nd of 2000 higher than 1,083 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 NCT00567879, the US trial registry maintained by the National Library of Medicine. NCT00567879 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.