Clinical trial NCT00663832: A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Male
Prostate
Cancer
HRPC
DACi
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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/exclusion criteria may apply

Primary outcomes:
measure: To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC
timeFrame: determine if MTD occurs after every 3 - 6 pts
Secondary outcomes:
measure: To compare the PK profile of i.v. LBH589 with and without docetaxel
timeFrame: PK assessment will occur during the first 2 weeks of each pt treatment. Minor safety throughout the study treatment phase
measure: To determine safety and tolerability of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC
timeFrame: PK assessment will occur during the first 2 weeks of each pt treatment
measure: To determine preliminary activity of i.v. LBH589 in combination with docetaxel and prednisone
timeFrame: PK assessment will occur during the first 2 weeks of each pt treatment
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Detroit
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Saint Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Durham
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: