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BATTLE Program: Sorafenib in Patients With NSCLC

NCT00411671 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2016-02-11

Study results available
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Summary

Primary Objective:

* To determine the 8 week progression-free survival rate (i.e. disease control rate) in patients with advanced non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen.

Secondary Objective:

The secondary objectives of this study will be to:

* Determine the overall response rate
* Determine the overall survival
* Determine the time to disease progression
* Assess the safety/toxicity of the study treatment
* Assess biomarker modulation in the tumor tissue and serum samples from the treatment.
* Assess plasma and intra-tumor concentrations of study treatment

Conditions

Interventions

DRUG

Sorafenib

400 mg By Mouth Twice Daily for 28 Days.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Bayer

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • George Blumenschein, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

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 NCT00411671 on ClinicalTrials.gov