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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00411528
First received: December 12, 2006
Last updated: March 7, 2013
Last verified: March 2013

December 12, 2006
March 7, 2013
September 2006
September 2012   (final data collection date for primary outcome measure)
Antitumor response based on PSA decrease [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]
Antitumor response based on PSA decrease
Complete list of historical versions of study NCT00411528 on ClinicalTrials.gov Archive Site
Measurable soft tissue response for both regimens [ Time Frame: Every 6 weeks or every 12 weeks if patient has bone disease for bone scan ] [ Designated as safety issue: No ]
Measurable soft tissue response for both regimens
Not Provided
Not Provided
 
Efficacy and Safety of Patupilone in Men (≥18 Years) With Metastatic Hormone Refractory Prostate Cancer
A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients 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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Hormone Refractory Prostate Cancer
Drug: Patupilone
  • Experimental: 1: 8 mg/m2 study drug + prednisone
    Patupilone 8 mg/m2 + prednisone 5 mg bid daily
    Intervention: Drug: Patupilone
  • 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
    Intervention: Drug: Patupilone
  • 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
    Intervention: Drug: Patupilone
  • Active Comparator: 4: Docetaxel 75 mg/m2
    Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily
    Intervention: Drug: Patupilone
de Liaño AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
185
September 2012
September 2012   (final data collection date for primary outcome measure)

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

Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Italy,   Spain,   Australia,   Belgium,   Singapore,   Germany
 
NCT00411528
CEPO906A2229, 2006-001822-23
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP