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
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 (Prostate-specific Antigen) has doubled from pretreatment baseline.
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 →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.
Exclusion Criteria:
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
Time To Progression (TTP) in Weeks
Time frame: 12 Months
Number of Toxicities in Patients Treated with PTK787
Time frame: 30 Days After Last Dose
Overall Survival
Time frame: 12 Months
No study locations are listed for this record.
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Michigan Rogel Cancer Center