A Phase II, Double-blind, Placebo-controlled, Randomised Study to Assess the Efficacy and Safety of Docetaxel (Taxotere)/Prednisolone/ZD6474 vs Docetaxel/Prednisolone/Placebo in Patients With Hormone Refractory Prostrate Cancer (HRPC)
18 Years
N/A
Male
Prostate Cancer, Metastatic, Hormone Refractory
Trial Information
A Phase II, Double-blind, Placebo-controlled, Randomised Study to Assess the Efficacy and Safety of Docetaxel (Taxotere)/Prednisolone/ZD6474 vs Docetaxel/Prednisolone/Placebo in Patients With Hormone Refractory Prostrate Cancer (HRPC)
Inclusion Criteria:
- Metastatic hormone refractory prostate cancer defined as those patients with evidence
of progression of disease in spite of castrate levels of testosterone indicated by
rising levels of PSA
- No previous chemotherapy although those patients that have received estramustine can
enter the study provided the estramustine was stopped 3 weeks before dosing of study
drug
- screening PSA values >20ng/ml. this must be confirmed by two separate measurements
at least 2 weeks apart
Exclusion Criteria:
- Treatment within 4 weeks before randomization and/or whilst on study, treatment with
the following: 1)non-approved or experimental drug, 2)treatment with a drug with
similar mechanism of action to ZD6474
- concurrent treatment with other anticancer agents, othr than docetaxel and
prednisolone as defined in the protocol
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Prostate Specific Antigen (PSA) Response
Outcome Description:
Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response
Outcome Time Frame:
PSA measurements were to be performed at screening, at baseline (>2 weeks after screening) and every 3 weeks during the study. Any response was to be confirmed 2-4 weeks after the initial assessment of a 50% fall in PSA from baseline
Safety Issue:
No
Principal Investigator
Gill Pover, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Brazil: National Health Surveillance Agency
Study ID:
D4200C00055
NCT ID:
NCT00498797
Start Date:
December 2005
Completion Date:
September 2008
Related Keywords:
- Prostate Cancer
- Metastatic
- Hormone Refractory
- prostate cancer
- zactima
- vandetanib
- metastatic
- Prostatic Neoplasms
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