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Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy

NCT00676650 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 873

Last updated 2013-03-08

Study results available
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Summary

This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Prednisone

5 mg BID, oral

DRUG

sunitinib

37.5 mg/day, oral, administered on a continuous daily dosing regimen

DRUG

Placebo

37.5 mg/day, oral, administered on a continuous daily dosing regimen

DRUG

Prednisone

5 mg BID, oral

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Israel
  • Italy
  • Peru
  • Poland
  • Portugal
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT00676650 on ClinicalTrials.gov