At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 108 enrolled
Drug / intervention
enzastaurin +3 moredrug
Likely dose
enzastaurin 1125 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study With and Without Enzastaurin in Combination With Docetaxel and Prednisone, Followed By Enzastaurin Maintenance as First-Line Treatment in Hormone Refractory Metastatic Prostate Cancer Patients
In Brief
A Phase 2 clinical trial evaluating enzastaurin, placebo, and 2 other interventions for Prostate Cancer. Completed, enrolled 108 participants across 28 sites in 3 countries.
Detailed Summary
The purpose of the study is to compare the response rates for prostate cancer patients taking chemotherapy plus enzastaurin versus chemotherapy plus placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesGermany, Italy, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2007
Enrollment StartJun 2007
Primary CompletionAug 2009
Study CompletionJun 2010
TodayJul 2026
First PostedApr 27, 2007
Enrollment StartJun 1, 2007
Primary CompletionAug 1, 2009
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 19.2 years ago
Interventions
enzastaurindrug
1125 mg loading dose, then 500 mg po QD until disease progression, toxicity, or maximum 3 years
placebodrug
Loading dose, then po QD until unblinding
docetaxeldrug
75 mg/m\^2 IV, every 21 days, six 21-day cycles, maximum 10 cycles
prednisonedrug
5 mg po BID, six 21-day cycles