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CompletedNCT00134355Updated Jan 19, 2015

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

A Phase 2 interventional study of PTK787 in Prostate Cancer, sponsored by University of Michigan Rogel Cancer Center. Completed. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-01-19.

Sponsored by University of Michigan Rogel Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study summary

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.

Read the 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 (Prostate-specific Antigen) has doubled from pretreatment baseline.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • antiangiogenesis therapy
  • vatalanib
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 5 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.

Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • Histologic or cytologic diagnosis of prostate cancer
  • No evidence of metastatic disease
  • PSA-only progression despite androgen depravation therapy and antiandrogen withdrawal
  • Patients must maintain castrate levels of testosterone (\<50ng/mL) or continue on LHRH ( Luteinizing Hormone-releasing Hormone) analog therapy.
  • ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (A measure of quality of life where 0 represents asymptomatic and 5 represents death)
  • No prior anti-VEGF therapy is allowed
  • No investigational or commercial agents or therapies other than LHRH agonists/antagonists may be administered concurrently with intent to treat the patient's malignancy
  • Age greater than or equal to 18 years
  • Life expectancy greater than 6 months
  • Normal organ and marrow function obtained within 14 days prior to registration
  • Must use adequate contraception prior to study entry and for the duration of study participation.

Exclusion criteria

Exclusion Criteria:

  • Patients may continue on a daily multivitamin, but all other herbal or alternative food supplements must be discontinued before registration.
  • Patients must be on stable doses of bisphosphonates which have been started no less than 6 weeks prior to protocol therapy.
  • Uncontrolled incurrent illness
  • Patients with a "currently active" second malignancy are not eligible.
  • Major surgery less than or equal to 4 weeks prior to randomization
  • Prior chemotherapy less than or equal to 3 weeks prior to registration
  • Prior biologic or immunotherapy less than or equal to 2 weeks prior to registration
  • Prior investigational drugs of any kind less than or equal to 4 weeks prior to registration
  • Patients who have had full field radiotherapy less than or equal to 4 weeks or limited field radiotherapy equal or less than 2 weeks prior to registration.
  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    PTK787

    PTK787: 250 mg orally twice daily x 2 wks, then 250 mg orally am, 500 mg orally pm x 1 wk, then 500 mg orally twice daily

    Drug: PTK787

Interventions

  • DrugPTK787
06

What researchers measure

Primary outcomes

  1. Time To Progression (TTP) in Weeks

    Time frame: 12 Months

Secondary outcomes

  1. Number of Toxicities in Patients Treated with PTK787

    Time frame: 30 Days After Last Dose

  2. Overall Survival

    Time frame: 12 Months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00134355
Lead sponsor
University of Michigan Rogel Cancer Center
Collaborators
Novartis
Responsible party
Sponsor
First posted
Aug 24, 2005
Start date
Jul 2005
Primary completion
Nov 2006
Completion
Mar 2007
Last update
Jan 19, 2015

Study contacts

Kathleen W. Beekman, MD
principal investigator · The University of Michigan Comprehensive Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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