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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Metastatic Hormone Refractory Prostate Cancer
 Drug: Patupilone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Phase II Trial of Patupilone (EPO906) Plus Prednisone Versus Docetaxel Plus Prednisone in Patients With Metastatic Hormone Refractory Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Antitumor response based on PSA decrease [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Enrollment: 185
Study Start Date: September 2006
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: 8 mg/m2 study drug + prednisone
Patupilone 8 mg/m2 + prednisone 5 mg bid daily
 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
 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
 Drug: Patupilone
Active Comparator: 4: Docetaxel 75 mg/m2
Docetaxel 75 mg/m2 once every 3 weeks + prednisone 5 mg bid daily
 Drug: Patupilone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411528

  Show 32 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.  This link exits the ClinicalTrials.gov site
Prostrate Cancer Study  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00411528     History of Changes
Other Study ID Numbers: CEPO906A2229, 2006-001822-23
Study First Received: December 12, 2006
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Prostate Cancer
Hormone Refractory
patupilone
docetaxel

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Prednisone
Docetaxel
Epothilone B
Hormones, Hormone Substitutes, and Hormone Antagonists
 Physiological Effects of Drugs
Pharmacologic Actions
Glucocorticoids
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013