At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓ECOG Performance Status 0, 1, or 2
- ✓Life expectancy of at least 12 weeks
- ✓Metastatic, measurable, histologically or cytologically documented NSCLC (includes squamous, large cell, or adenocarcinoma); histological confirmation required if single metastatic site
- ✕Cardiac arrhythmia requiring anti-arrhythmics (excluding beta-blockers or digoxin), symptomatic CAD/ischemia, MI within last 6 months, or CHF >NYHA Class II
- ✕Uncontrolled hypertension
- ✕Mixed histologies
- ✕Active clinically serious infections (>grade 2 NCI CTCAE v3.0)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Multicenter Uncontrolled Trial of BAY43-9006 in Patients With Relapsed or Refractory Advanced Non-small Cell Lung Carcinoma
In Brief
A Phase 2 clinical trial evaluating Sorafenib (Nexavar, BAY43-9006) for Cancer and Carcinoma, Non-Small Cell Lung. Completed, enrolled 52 participants across 2 sites in 2 countries.
Detailed Summary
The purpose of the study is to evaluate if BAY43-9006 has an effect on the tumors, how long the effect continues, if the patients receiving BAY43-9006 will live longer. * If BAY43-9006 has an effect on the quality of life of patients with non-small cell lung cancer. * If BAY43-9006 helps to slow the worsening of non-small cell lung cancer. * If BAY43-9006 prevents the growth of, or shrinks non-small cell lung tumors and/or their metastases.
Study Details
Timeline
Interventions
BAY43-9006 400 mg bid X 28 day cycles \[Continuous treatment for a maximum of 2 years; potential for compassionate use and long term survival follow-up post drug discontinuation.