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NCT00532389 · ClinicalTrials.gov registry record · Phase 1

Safety Study of LBH589 When Given in Combination With Bortezomib in Adult Patients With Multiple Myeloma

A Phase 1 study of Multiple Myeloma, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
62
Enrollment target
16
Study locations

NCT00532389 is a Phase 1 study of Multiple Myeloma that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 62 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (89% lower). The trial reports 16 study locations across 12 states.

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The verdict

NCT00532389, a Phase 1 study of Multiple Myeloma, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
62 participants
Enrollment target
16
Study locations

Study Summary

This study comprises of a dose-escalation and dose expansion phase and will determine the maximum tolerated dose of oral Panobinostat on a continuous schedule in adult in combination with bortezomib. Safety, tolerability, PK and PD profile of the combined treatments will be assessed as secondary objectives. Dose expansion phase will explore in a non continuous Panobinostat schedule with bortezomib and dexamethasone, safety and tolerability and PK profile of Panobinostat and Bortezomib with and without Dexamethasone

Conditions Studied

Multiple Myeloma

Interventions

  • DRUG LBH589

Study Locations (16)

Other

  • Novartis Investigative Site - Berlin
  • Novartis Investigative Site - Kiel
  • Novartis Investigative Site - Leipzig
  • Novartis Investigative Site - München
  • Novartis Investigative Site - Würzburg

Florida

  • Innovative Medical Research of South Florida Dept.ofInnovativeMedResearch - Miami Shores

Massachusetts

  • Dana Farber Cancer Institute Clinical Research Coordinator - Boston

New Jersey

  • Hackensack University Medical Center Multiple Myeloma Division - Hackensack

Washington

  • Swedish Medical Center Dept.ofSwedishMedicalCtr. - Seattle

Australian Capital Territory

  • Novartis Investigative Site - Canberra

British Columbia

  • Novartis Investigative Site - Vancouver

Quebec

  • Novartis Investigative Site - Montreal

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2007-10
Est. Completion 2013-10
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT00532389

The ClinicalTrials.gov registry entry for NCT00532389 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (89% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which LBH589 is the first listed.

NCT00532389 reports 16 study locations spanning 12 distinct geographic areas - top geographies include Other, Florida, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00532389 about?

NCT00532389 is a clinical study titled "Safety Study of LBH589 When Given in Combination With Bortezomib in Adult Patients With Multiple Myeloma". This study comprises of a dose-escalation and dose expansion phase and will determine the maximum tolerated dose of oral Panobinostat on a continuous schedule in adult in combination with bortezomib. Safety, tolerability, PK and PD profile of the combined treatments will be assessed as secondary obj...

What is the current status of trial NCT00532389?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2007-10. Estimated completion is 2013-10.

What conditions does trial NCT00532389 study?

This clinical trial studies the following conditions: Multiple Myeloma.

What interventions are being tested in trial NCT00532389?

The interventions under investigation include: LBH589 (DRUG).

Who is sponsoring clinical trial NCT00532389?

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

Where is trial NCT00532389 being conducted?

This trial has 16 study locations across Florida, Massachusetts, New Jersey, Washington, Australian Capital Territory. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.