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Completed

NCT Number: NCT00663832

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LBH589 (i.v. panobinostat)

Drug

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

Other names: Panobinostat

Primary outcomes

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

    Time frame: determine if MTD occurs after every 3 - 6 pts

Secondary outcomes

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

    Time frame: PK assessment will occur during the first 2 weeks of each pt treatment. Minor safety throughout the study treatment phase

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

    Time frame: PK assessment will occur during the first 2 weeks of each pt treatment

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

    Time frame: PK assessment will occur during the first 2 weeks of each pt treatment

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
First posted
Apr 22, 2008
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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