Study of PTK787 in the Treatment of Patients With Non-Metastatic Androgen Independent Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00134355
First received: August 23, 2005
Last updated: February 17, 2010
Last verified: January 2007

August 23, 2005
February 17, 2010
July 2005
Not Provided
Assess the efficacy of PTK787/ZK 222584 in terms of prostate-specific antigen (PSA) response, in patients with hormone-refractory prostate cancer
The primary objective of this Phase II trial is to assess the efficacy of PTK787/ZK 222584 in terms of PSA response, in patients with hormone-refractory prostate cancer.
Complete list of historical versions of study NCT00134355 on ClinicalTrials.gov Archive Site
  • Evaluate the toxicity in patients treated with PTK787/ZK 222584
  • Assess overall survival in patients treated with PTK787/ZK 222584
  • Assess effect of PTK787/ZK 222584 on circulating VEGF levels in patients treated with PTK787/ZK 222584
  • Evaluate the toxicity in patients treated with PTK787/ZK 222584.
  • Assess overall survival in patients treated with PTK787/ZK 222584
  • Assess effect of PTK787/ZK 222584 on circulating VEGF levels in patients treated with PTK787/ZK 222584
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Study of PTK787 in the Treatment of Patients With Non-Metastatic Androgen Independent Prostate Cancer
Phase II Evaluation of PTK787, an Oral Vascular Endothelial Growth Factor Inhibitor, in Patients With Non-Metastatic Androgen Independent Prostate Cancer

The purpose of this study is to evaluate PTK787/ZK 222584, a drug that blocks new blood vessel growth, in the treatment of patients with non-metastatic androgen independent prostate cancer. This study will assess the safety and tolerability of PTK787/ZK 222584, and evaluate serum vascular endothelial growth factor (VEGF) levels.

This is an open-label, phase II trial of PTK787/ZK 222584. Patients will receive 750 mg daily for one week, 1000 mg daily for the second week, and then 1250 mg per day thereafter.

Response Assessment: In the absence of toxicity or clinical progression, patients will remain in the study until their PSA has doubled from pretreatment baseline.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Prostate Cancer
Drug: PTK787/ZK 222584
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2008
Not Provided

Inclusion Criteria:

  • Patients must have rising PSA as demonstrated by two rising values at least one month apart while receiving hormonal therapy.

Exclusion Criteria:

  • Patients must not be on nonsteroidal antiandrogen blockade.
  • Patients must have no evidence of disease on bone scan or computed tomography (CT) scan of the abdomen/pelvis.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00134355
UMCC 2005.014
Not Provided
Not Provided
University of Michigan
Novartis
Principal Investigator: Kathleen W. Beekman, MD The University of Michigan Comprehensive Cancer Center
University of Michigan
January 2007

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