A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer

An Open Label, Single Arm, Phase Ib Dose Finding Study of i.v. Panobinostat (LBH589) With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00663832

Enrollment

Registered

2008-04-22

Start date

2008-02-29

Completion date

Unknown

Last updated

2020-12-19

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

Conditions

Prostate Cancer

Keywords

Male, Prostate, Cancer, HRPC, DACi

Brief summary

This Phase Ib dose escalation study is designed to characterize the safety, tolerability and preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and prednisone in the 1st line treatment of patients with hormone refractory prostate cancer.

Interventions

DRUGLBH589 (i.v. panobinostat)

i.v. LBH589 dose levels: 10, 15, or 20 mg/m2 i.v. docetaxel 75 or 60 mg/m2 oral prednisone 5mg bid. LBH589 i.v. administered on days 1 and 8 in combination with docetaxel i.v. on day 1 and prednisone p.o 5mg bid every day of a 21-day cycle

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* HRPC patients * Evidence of disease progression * Self care, able to perform light work activities * Willing to use contraception throughout the study and for 12 weeks after study completion

Exclusion criteria

* History of other cancers not curatively treated with no evidence of disease for more than 5 years. * Prior radiotherapy within 3 weeks of starting study treatment * Prior radiopharmaceuticals (strontium, samarium). * Impaired cardiac function * Heart disease * Liver or renal disease with impaired functions. Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC	determine if MTD occurs after every 3 - 6 pts

Secondary

Measure	Time frame
To compare the PK profile of i.v. LBH589 with and without docetaxel	PK assessment will occur during the first 2 weeks of each pt treatment. Minor safety throughout the study treatment phase
To determine safety and tolerability of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC	PK assessment will occur during the first 2 weeks of each pt treatment
To determine preliminary activity of i.v. LBH589 in combination with docetaxel and prednisone	PK assessment will occur during the first 2 weeks of each pt treatment

Countries

Canada, United States

Outcome results

None listed

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