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NCT00493766 · ClinicalTrials.gov registry record · Phase 1

Safety of LBH589 Alone and in Combination With IV Docetaxel and Prednisone

A Phase 1 study, sponsored by Novartis Pharmaceuticals.

Terminated
Registry status
Phase 1
Development phase
16
Enrollment target

NCT00493766: Clinical Trial Phase 1 study, sponsored by Novartis Pharmaceuticals.

NCT00493766 is a Phase 1 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00493766, a Phase 1 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.

TERMINATED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

This is a parallel, two-arm, open-label, multicenter phase IA/IB study of LBH589 (oral formulation) alone and in combination with docetaxel in patients with progressing hormone refractory prostate cancer. This study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg two times a day , and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile

Interventions

  • DRUG LBH589

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2006-05
Phase Phase 1
Novartis Pharmaceuticals

1,375 total trials

Why NCT00493766 stopped before completion

NCT00493766 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

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

NCT00493766 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00493766 about?

NCT00493766 is a clinical study titled "Safety of LBH589 Alone and in Combination With IV Docetaxel and Prednisone". This is a parallel, two-arm, open-label, multicenter phase IA/IB study of LBH589 (oral formulation) alone and in combination with docetaxel in patients with progressing hormone refractory prostate cancer. This study is designed to determine the maximum tolerated dose of LBH589 as a single agent and ...

What is the current status of trial NCT00493766?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2006-05.

What interventions are being tested in trial NCT00493766?

The interventions under investigation include: LBH589 (DRUG).

Who is sponsoring clinical trial NCT00493766?

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 NCT00493766's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 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 NCT00493766, the US trial registry maintained by the National Library of Medicine. NCT00493766 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.