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
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: PTK787/ZK 222584
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Evaluation of PTK787, an Oral Vascular Endothelial Growth Factor Inhibitor, in Patients With Non-Metastatic Androgen Independent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Assess the efficacy of PTK787/ZK 222584 in terms of prostate-specific antigen (PSA) response, in patients with hormone-refractory prostate cancer

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: July 2005
Study Completion Date: April 2008
Detailed Description:

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.

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134355

Sponsors and Collaborators
University of Michigan
Novartis
Investigators
Principal Investigator: Kathleen W. Beekman, MD The University of Michigan Comprehensive Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00134355     History of Changes
Other Study ID Numbers: UMCC 2005.014
Study First Received: August 23, 2005
Last Updated: February 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
antiangiogenesis therapy
vatalanib

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Endothelial Growth Factors
Vatalanib
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Growth Substances
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 14, 2014