A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Metastatic Hormone Refractory Prostate Cancer (HRPC)
18 Years
N/A
Male
Prostatic Neoplasms
Trial Information
A Phase 1/2 Safety And Pharmacokinetic Study Of SU011248 In Combination With Docetaxel (Taxotere) And Prednisone In Patients With Metastatic Hormone Refractory Prostate Cancer (HRPC)
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Patients must have progressive hormone-refractory prostate cancer (HRPC): patients
must have undergone primary hormone treatment (e.g. orchiectomy or gonadotropin
releasing hormone analog with or without antiandrogens). For patients who received
antiandrogen therapy, disease progression must have been determined after
antiandrogen discontinuation
- Progressive disease based on either non-measurable disease and an elevated PSA OR
measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria:
- Prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF
receptor inhibitor, platelet-derived growth factor (PDGF) receptor inhibitor or
anti-angiogenic treatment of any kind including investigational therapy
- Prior chemotherapy
- Uncontrolled pain at baseline, impending complication from bone metastasis (fracture
and/or compression) and/or presence of urinary obstruction (urinary retention,
hydronephrosis)
- History of cardiac dysfunction, QT interval corrected for heart rate (QTc) >450 msec
- Central Nervous System (CNS) involvement
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:
Percentage of Participants With Prostate Specific Antigen (PSA) Response
Outcome Description:
PSA response rate, which is defined as a greater than or equal to a 50% decrease in PSA from baseline, that is subsequently confirmed.
Outcome Time Frame:
Baseline, Day 1 of each 21-day cycle
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A6181043
NCT ID:
NCT00137436
Start Date:
October 2005
Completion Date:
March 2010
Related Keywords:
- Prostatic Neoplasms
- First-line treatment of metastatic hormone-refractory prostate cancer SUTENT in combination with docetaxel and prednisone
- Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Springfield, Illinois 62701-1014 |
| Pfizer Investigational Site | Houston, Texas 77030 |
| Pfizer Investigational Site | Carmel, Indiana 46032 |
| Pfizer Investigational Site | Asheville, North Carolina 28801 |
| Pfizer Investigational Site | Eugene, Oregon 97401 |
| Pfizer Investigational Site | Easley,, South Carolina 29640 |
| Pfizer Investigational Site | Milwaukee, Wisconsin 53215 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
