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Sorafenib and Erlotinib or Sorafenib Alone in Advanced Non-Small Cell Lung Cancer Progressing on Erlotinib

NCT00609804 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2016-04-08

Study results available
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Summary

This is a randomized, open-label, multi-center, Phase II study of treatment of patients with advanced NSCLC who have progressed on erlotinib with the combination of sorafenib and erlotinib or sorafenib alone.

Conditions

Interventions

DRUG

Sorafenib

Sorafenib 400 mg twice daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.

DRUG

Erlotinib

Erlotinib 150 mg once daily by mouth

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • OSI Pharmaceuticals

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • David Spigel, M.D. · SCRI Development Innovations, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2012-05-31
Completion
2014-11-30

Countries

  • United States

Study Locations

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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 NCT00609804 on ClinicalTrials.gov