Clinical trial · Interventional
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
NCT00134355CI-TRIAL-00016650completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PTK787 | Drug | Vatalanib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PTK787
- description
- 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
- interventionNames
- Drug: PTK787
Primary outcomes (1)
- measure
- Time To Progression (TTP) in Weeks
- timeFrame
- 12 Months
Secondary outcomes (2)
- measure
- Number of Toxicities in Patients Treated with PTK787
- timeFrame
- 30 Days After Last Dose
- measure
- Overall Survival
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.