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NCT00777335 · ClinicalTrials.gov registry record · Phase 2

Study of Panobinostat Monotherapy in Women With v-ERB-B2 Avian Erythroblastic Leukemia Viral Oncogene Homolog 2 (HER2) Positive Locally Recurrent or Metastatic Breast Cancer

A Phase 2 study, sponsored by Translational Research in Oncology.

Terminated
Registry status
Phase 2
Development phase
4
Enrollment target

NCT00777335: Clinical Trial Phase 2 study, sponsored by Translational Research in Oncology.

NCT00777335 is a Phase 2 study that was terminated before completion, run by Translational Research in Oncology. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00777335, a Phase 2 study, was terminated before completion, sponsored by Translational Research in Oncology.

TERMINATED
Registry status
Phase 2
Development phase
4 participants
Enrollment target

Study Summary

The purpose of the study is to assess the benefit of panobinostat monotherapy given either orally or i.v. to women with HER2-positive locally recurrent or metastatic breast cancer

Primary Outcome

The assessment of OR is based on the response of target lesion, of non-target lesion and on presence of new lesions (RECIST Criteria (V1.0)-assessed by CT scan spiral and bone scan) * CR:Disappearance of all target lesions * PR:\>=30% increase in the sum of the longest diameter (SLD),taking as reference the nadir SLD * Progressive Disease (PD):\>=20% increase in the SLD, taking as reference the nadir SLD, or the appearance of one or more new lesions * Stable Disease(SD):Neither sufficient shrin

Interventions

  • DRUG Panobinostat - LBH589

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2009-02
Est. Completion 2010-03
Phase Phase 2

Why NCT00777335 stopped before completion

NCT00777335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Panobinostat - LBH589 is the first listed.

NCT00777335 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00777335 about?

NCT00777335 is a clinical study titled "Study of Panobinostat Monotherapy in Women With v-ERB-B2 Avian Erythroblastic Leukemia Viral Oncogene Homolog 2 (HER2) Positive Locally Recurrent or Metastatic Breast Cancer". The purpose of the study is to assess the benefit of panobinostat monotherapy given either orally or i.v. to women with HER2-positive locally recurrent or metastatic breast cancer

What is the current status of trial NCT00777335?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2009-02. Estimated completion is 2010-03.

What interventions are being tested in trial NCT00777335?

The interventions under investigation include: Panobinostat - LBH589 (DRUG).

Who is sponsoring clinical trial NCT00777335?

This trial is sponsored by Translational Research in Oncology, which has 8 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00777335's enrollment target sits among peer trials

4 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00777335, the US trial registry maintained by the National Library of Medicine. NCT00777335 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.