Phase II Evaluation of PTK787, an Oral Vascular Endothelial Growth Factor Inhibitor, in Patients With Non-Metastatic Androgen Independent Prostate Cancer


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

Phase II Evaluation of PTK787, an Oral Vascular Endothelial Growth Factor Inhibitor, in Patients With Non-Metastatic Androgen Independent Prostate Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Kathleen W. Beekman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Michigan Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

UMCC 2005.014

NCT ID:

NCT00134355

Start Date:

July 2005

Completion Date:

April 2008

Related Keywords:

  • Prostate Cancer
  • antiangiogenesis therapy
  • vatalanib
  • Prostatic Neoplasms

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