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A Study of Nimotuzumab in Combination With Radiation Therapy in Patients With Brain Metastases

NCT00872482 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2011-07-01

No results posted yet for this study

Summary

This is a randomized, Phase II study designed to investigate Nimotuzumab plus whole-brain radiation therapy (WBRT)and to compare it rith WBRT alone in patients with brain metastases from non-small cell lung cancer (NSCLC). The purpose of the study is to assess the efficacy of nimotuzumab in combination with WBRT.

Conditions

  • Metastatic Non-Small Cell Lung Cancer

Interventions

DRUG

nimotuzumab

Nimotuzumab (200 mg fixed dose) will be administered by the intravenous route weekly during WBRT and following WBRT Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day.

Sponsors & Collaborators

  • CIMYM BioSciences

    collaborator OTHER

  • YM BioSciences

    lead INDUSTRY

Principal Investigators

  • Anthony Brade, M.D. · Assitant Professor, Department of Radiation Oncology, University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-06-30
Completion
2011-07-31

Countries

  • United States
  • Canada
  • Cuba
  • Pakistan
  • South Korea

Study Locations

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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 NCT00872482 on ClinicalTrials.gov