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A Study of an Experimental Chemotherapy Combination to Treat Hormone Refractory Prostate Cancer

NCT00642018 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2019-04-03

Study results available
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Summary

The primary purpose of this study is to determine whether LY2181308 in combination with docetaxel is safe and effective treatment for hormone refractory prostate cancer patients.

Conditions

Interventions

DRUG

docetaxel

Docetaxel 75 milligrams per square meter (mg/m²) intravenously on Day 1 of a 21-day cycle. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.

DRUG

LY2181308 sodium

LY2181308 sodium (referred to as LY2181308 throughout this record) administered weekly plus docetaxel 75 mg/m² intravenously administered every 21 days. Patients may receive up to 10 cycles of study therapy or until progressive disease. Additional cycles may be approved by sponsor as long as the patient is benefitting from therapy.

DRUG

Prednisone

Prednisone 5 mg given orally twice daily continuously while receiving docetaxel therapy

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2011-08-31
Completion
2012-04-30

Countries

  • United States
  • Germany
  • Poland
  • Spain

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 NCT00642018 on ClinicalTrials.gov