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NCT00878436 · ClinicalTrials.gov registry record · Phase 1

Safety and Efficacy Studies of Panobinostat and Bicalutamide in Patients With Recurrent Prostate Cancer After Castration

A Phase 1 study, sponsored by NYU Langone Health.

Completed
Registry status
Phase 1
Development phase
52
Enrollment target

NCT00878436: Completed Phase 1 study, sponsored by NYU Langone Health.

NCT00878436 is a Phase 1 study that has completed, run by NYU Langone Health. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00878436, a Phase 1 study, has completed, sponsored by NYU Langone Health.

COMPLETED
Registry status
Phase 1
Development phase
52 participants
Enrollment target

Study Summary

This trial is designed to investigate the safety, dosing schedule, and efficacy of the combination treatment of Panobinostat (a histone deacetylase inhibitor) and hormone therapy for recurrent prostate cancer. This trial is at its Phase II stage. As of July 23, 2013 Arm B was closed to accrual, all the remaining slots in accrual will be allocated to Arm A.

Primary Outcome

measured by PSA and /or metastases progression criteria by body CT following RECIST criteria 1.1 and/or bones scan following the appearance of at least 2 new bone metastases and confirmation of 2 additional bone metastasis on a subsequent bone scan 6-8 weeks later and/or clinical progression. Only participants who completed two or more treatment cycles were assessed for this outcome measure.

Interventions

  • DRUG Bicalutamide
  • DRUG Panobinostat

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2009-06
Est. Completion 2015-07
Phase Phase 1
NYU Langone Health

1,164 total trials

What the finished NCT00878436 record still lists

NCT00878436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).

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

NCT00878436 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00878436 about?

NCT00878436 is a clinical study titled "Safety and Efficacy Studies of Panobinostat and Bicalutamide in Patients With Recurrent Prostate Cancer After Castration". This trial is designed to investigate the safety, dosing schedule, and efficacy of the combination treatment of Panobinostat (a histone deacetylase inhibitor) and hormone therapy for recurrent prostate cancer. This trial is at its Phase II stage. As of July 23, 2013 Arm B was closed to accrual, all ...

What is the current status of trial NCT00878436?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2009-06. Estimated completion is 2015-07.

What interventions are being tested in trial NCT00878436?

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

Who is sponsoring clinical trial NCT00878436?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00878436's enrollment target sits among peer trials

52 956th of 2000 higher than 1,032 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 NCT00878436, the US trial registry maintained by the National Library of Medicine. NCT00878436 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.