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OpenTrials
Completed

NCT Number: NCT00411528

Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer

The objective of this study is to assess the response of patupilone plus prednisone compared to docetaxel plus prednisone on prostate specific antigen (PSA) in patients with metastatic hormone refractory prostate cancer. Additionally, this study will assess the response on measureable disease and the effects on patient-reported outcomes.

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Key information

Conditions

Metastatic Hormone Refractory 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 2

Primary location

Novartis Investigative Site, Kogarah, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must be ≥ 18 years of age
  • Confirmed and documented diagnosis of prostate cancer
  • Confirmed and documented evidence of progression of disease (hormone refractory)
  • Low testosterone levels
  • Chemotherapy-naïve

Exclusion criteria

  • Recent radiation therapy (within 4 weeks)
  • Known brain metastasis
  • Peripheral neuropathy
  • Active diarrhea
  • Significant illnesses such as heart disease, diabetes, or chronic or uncontrolled infections
  • Allergic reactions to patupilone or docetaxel or prednisone or similar compounds

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Patupilone

Drug

Other names: EPO906

Prednisone

Drug

docetaxel

Drug

Primary outcomes

  1. Antitumor response based on PSA decrease

    Time frame: Every 3 weeks

Secondary outcomes

  1. Measurable soft tissue response for both regimens

    Time frame: Every 6 weeks or every 12 weeks if patient has bone disease for bone scan

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Dec 14, 2006
Registry last updated
Dec 17, 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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