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TerminatedNCT00419536Updated Apr 8, 2010

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

A Phase 1 interventional study of LBH589 in Hormone Refractory Prostate Cancer Disease, sponsored by Novartis Pharmaceuticals. Terminated at 3 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-04-08.

Sponsored by Novartis Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
108
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study summary

This 2-arm study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg twice daily (second arm) and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile.

02

Conditions studied

  • Hormone Refractory Prostate Cancer Disease

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Keywords

  • LBH
  • LBH589
  • Prostate Cancer
  • HRPC
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 108 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with hormone refractory prostate cancer
  • Patients must have metastatic disease with at least 1 measurable soft tissue lesion that can be assessed by CT or MRI and/or detectable lesion(s) on bone scintigraphy scan. Patients with only elevated PSA levels are not eligible for entry.
  • Patients must meet laboratory inclusion criteria defined in the protocol
  • Patients must be able to provide written informed consent

Exclusion criteria

Exclusion Criteria:

  • Patients with prior or concurrent brain metastases
  • Impaired cardiac, gastrointestinal, kidney or liver function
  • Use of therapeutic androgens Other protocol-defined inclusion/exclusion criteria may apply
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
108 participants

Interventions

  • DrugLBH589
06

What researchers measure

Primary outcomes

  1. To determine the maximum tolerated dose

Secondary outcomes

  1. Safety

  2. Tolerability

  3. Biologic activity

  4. Pharmacokinetic profile

07

Study locations

3 sites
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02115-6084, United States
  • Washington University School of Medicine
    St. Louis, Missouri 63119, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10021, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00419536
Lead sponsor
Novartis Pharmaceuticals
First posted
Jan 8, 2007
Start date
May 2006
Last update
Apr 8, 2010

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.

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