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Evaluation of Cabazitaxel in Patients With Brain Metastasis Secondary to Breast Cancer and NSCLC

NCT01913067 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2014-07-24

No results posted yet for this study

Summary

A phase II trial evaluating Cabazitaxel in patients with brain metastasis secondary to breast and non-small-cell lung cancer (NSCLC).

OBJECTIVES:

Primary:

The purpose of this study is to determine if cabazitaxel can induce a reduction in the size brain metastasis in metastatic HER2-negative breast cancer and NSCLC with brain metastasis who were not previously treated with whole brain irradiation or require immediate brain irradiation.

Secondary:

* To determine the effect of cabazitaxel on the time to initiating whole brain irradiation or radiosurgery
* To determine the effect of cabazitaxel on the time to developing neurological symptoms
* To determine the effect of cabazitaxel on the time to disease progression in the brain
* To determine the effect of cabazitaxel on the time to disease progression outside the brain. This will be evaluated separately for the breast and NSCLC cohorts To determine the objective extra-cranial response (if applicable). This will be evaluated separately in the breast and NSCLC cohorts
* To determine the safety of cabazitaxel

Conditions

Interventions

DRUG

Cabazitaxel

Intravenous, 25 mg/m2 every 3 weeks

PROCEDURE

Contrast-enhanced whole brain MRI

Evaluation of the volumetric reduction in the size of the brain lesion(s).

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Jules Bordet Institute

    lead OTHER

Principal Investigators

  • Ahmad Awada, MD, PhD · Institute Jules Bordet

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-05-31
Completion
2016-09-30

Countries

  • Belgium

Study Locations

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Entities

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 NCT01913067 on ClinicalTrials.gov