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Phase I Study of ZD4054 (Zibotentan) and Docetaxel in Patients With Metastatic HRPC

NCT00314782 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2013-03-12

No results posted yet for this study

Summary

Two-part, multi-center study design to establish a maximum tolerated dose (MTD) of ZD4054 in combination with docetaxel and to explore its safety, tolerability, pharmacokinetic (PK) profiles and clinical efficacy in patients with metastatic hormone-refractory prostate cancer (HRPC)

Conditions

Interventions

DRUG

ZD4054 (Zibotentan)

oral tablet

DRUG

Docetaxel

intravenous infusion

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Emerging Oncology Medical Science Director, MD · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-03-31
Completion
2009-03-31

Countries

  • United States
  • Germany
  • United Kingdom

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 NCT00314782 on ClinicalTrials.gov