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

A Phase IA/IB, Two Arm, Multi-center, Open-label, Dose Escalation Study of Oral LBH589 Alone and in Combination With IV Docetaxel and Oral Prednisone in Hormone Refractory Prostate Cancer (HRPC)

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00419536

Enrollment

108

Registered

2007-01-08

Start date

2006-05-31

Completion date

Unknown

Last updated

2010-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hormone Refractory Prostate Cancer Disease

Keywords

LBH, LBH589, Prostate Cancer, HRPC

Brief 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.

Interventions

DRUGLBH589

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

* Patients with prior or concurrent brain metastases * Impaired cardiac, gastrointestinal, kidney or liver function * Use of therapeutic androgens Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
To determine the maximum tolerated dose	—

Secondary

Measure	Time frame
Safety	—
Tolerability	—
Biologic activity	—
Pharmacokinetic profile	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026