CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
enzastaurindrug
Likely dose
Not stated in record
Key inclusion· 8
  • Cohort 1: Rising PSA (≤5 ng/mL, at least 3 measurements 1 week apart) with castrate testosterone levels (<50 ng/dL) maintained by LHRH agonist or bilateral orchiectomy, without metastatic disease
  • Cohort 1: No prior chemotherapy for prostate cancer or other indications within 2 years of study entry
  • Cohort 2: One prior docetaxel-based chemotherapy regimen
  • Cohort 2: Metastatic prostate cancer with bone or soft-tissue disease
Key exclusion· 5
  • Unable to swallow oral medication
  • Serious heart condition
  • Currently receiving another anti-cancer therapy
  • Received another experimental drug within the last 30 days

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00428714
NCT00428714Phase 2Completed

Phase 2 Trial Oral Enzastaurin in Prostate Cancer Patients Who Have Rising PSA (1) During Hormonal Manipulation and (2) After First-Line Cytotoxic Chemotherapy

Eli Lilly and Company·interventional·Posted Jan 30, 2007·Updated Nov 25, 2020

In Brief

A Phase 2 clinical trial evaluating enzastaurin for Prostate Cancer. Completed, enrolled 73 participants across 11 sites.

Detailed Summary

The purpose is to see how quickly two different types of prostate cancer participants respond when taking enzastaurin. Cohort 1 - asymptomatic participants with androgen-independent prostate-specific antigen (PSA)-progressive disease without clinical or radiographic evidence of metastatic disease. Cohort 2 - participants with androgen-independent metastatic prostate cancer (documented bone or soft tissue metastases) with rising PSA, clinical, radiographic disease progression following one prior docetaxel-based regimen

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 30, 2007
Enrollment StartJan 1, 2007
Primary CompletionJun 1, 2009
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 19.4 years ago

Interventions

enzastaurindrug

Administered orally