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

Condition(s) targeted: Prostate Cancer

Intervention: LBH589 (i.v. panobinostat) (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Overall contact:
Novartis Pharmaceuticals, Phone: +1-800-340-6843

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.

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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC

Secondary outcome:

To compare the PK profile of i.v. LBH589 with and without docetaxel

To determine safety and tolerability of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC

To determine preliminary activity of i.v. LBH589 in combination with docetaxel and prednisone

Minimum age: N/A. Maximum age: N/A. Gender(s): Male.

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

Novartis Pharmaceuticals, Phone: +1-800-340-6843

Novartis Investigative Site, Ontario, Canada; Recruiting

Novartis Investigative Site, Vancouver, British Columbia, Canada; Recruiting

Wayne State University/Karmanos Cancer Center, Detroit, Michigan 48201, United States; Recruiting
Brenda Dickow, Phone: 313-576-8715, Email: dickowb@karmamos.org
Ulka Vaishampayan, M.D., Principal Investigator

Washington University School of Medicine in St. Louis, St. Louis, Missouri 63110, United States; Recruiting
Jessica Weinstein, Phone: 314-747-8085, Email: jweinstei@im.wustl.edu
Joel Picus, M.D., Principal Investigator

Nevada Cancer Institute, Las Vegas, Nevada 89135, United States; Recruiting
Sandra Lehr, Phone: 702-822-5433, Email: slahr@nvcancer.org
Bryan Wong, M.D., Principal Investigator

Memorial Sloane Kettering Cancer Center, New York, New York 10017, United States; Recruiting
Erika Tanaka, Phone: 646-422-4330, Email: tanakae@mskcc.org
Dana Rothkopf, M.D, Principal Investigator

Oregon Health & Science University, Portland, Oregon 97239, United States; Recruiting
Danny DeHaze, Phone: 503-418-9392, Email: dehazed@ohsu.edu
Justina Barberini, Email: barberin@ohsu.edu
Joshi Alumkal, M.D., Principal Investigator

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Starting date: February 2008
Last updated: September 21, 2009