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A Study of CNTO 328 in Patients With Metastatic Hormone-Refractory Prostate Cancer

NCT00401765 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-05-26

No results posted yet for this study

Summary

The purpose of this study is to determine the safety of docetaxel and CNTO 328 when given together as a treatment. The second goal of this study is to determine if a combination of docetaxel and CNTO 328 has an effect on prostate cancer.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

CNTO 328

Patients will receive 6 mg/kg CNTO 328 in treatment phase of cohort 1A and cohort 1B; 9 mg/kg CNTO 328 in treatment phase of cohort 2; and 12 mg/kg CNTO 328 in treatment phase of cohort 3.

DRUG

Docetaxel

Patients will receive 75 mg/m2 docetaxel in run-in phase of cohort 1A, cohort 2, and cohort 3; and in treatment phase of cohort 1A, cohort 1B, cohort 2, and cohort 3.

Sponsors & Collaborators

  • Centocor, Inc.

    lead INDUSTRY

Principal Investigators

  • Centocor, Inc. Clinical Trial · Centocor, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00401765 on ClinicalTrials.gov