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

Overview

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.

Full Title of Study: “A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2012

Interventions

  • Drug: Patupilone
  • Drug: prednisone
  • Drug: docetaxel

Arms, Groups and Cohorts

  • Experimental: 1: 8 mg/m2 study drug + prednisone
    • Patupilone 8 mg/m2 + prednisone 5 mg bid daily
  • Experimental: 2: study drug + prednisone days 1 -8
    • Patupilone 10 mg/m2 + prednisone days 1 -8 at 25 mg bid, day 9 at 20 mg bid, day 10 at 15 mg bid, day 11 at 10 mg bid, day 12 – 21 at 5 mg bid
  • Experimental: 3: Study drug + prednisone days 1 – 4
    • Patupilone 10 mg/m2 + prednisone days 1 – 4 at 5 mg bid, days 5 -12 at 25 mg bid, day 13 at 20 mg bid, day 14 at 15 mg bid, day 15 at 10 mg bid, day 16 – 21 at 5 mg bid
  • Active Comparator: 4: Docetaxel 75 mg/m2 + prednisone 5 mg bid daily
    • Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily

Clinical Trial Outcome Measures

Primary Measures

  • Antitumor response based on PSA decrease
    • Time Frame: Every 3 weeks

Secondary Measures

  • Measurable soft tissue response for both regimens
    • Time Frame: Every 6 weeks or every 12 weeks if patient has bone disease for bone scan

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Director, Novartis Pharmaceuticals

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