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A Phase 2 Study With Enzastaurin Plus Chemotherapy or Placebo Plus Chemotherapy for Prostate Cancer Patients

NCT00466440 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2020-11-06

Study results available
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Summary

The purpose of the study is to compare the response rates for prostate cancer patients taking chemotherapy plus enzastaurin versus chemotherapy plus placebo.

Conditions

Interventions

DRUG

enzastaurin

1125 mg loading dose, then 500 mg po QD until disease progression, toxicity, or maximum 3 years

DRUG

placebo

Loading dose, then po QD until unblinding

DRUG

docetaxel

75 mg/m\^2 IV, every 21 days, six 21-day cycles, maximum 10 cycles

DRUG

prednisone

5 mg po BID, six 21-day cycles

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-08-31
Completion
2010-06-30

Countries

  • United States
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00466440 on ClinicalTrials.gov