Cancer Clinical Trial
Official title:
A Phase II Multicenter Uncontrolled Trial of BAY43-9006 in Patients With Relapsed or Refractory Advanced Non-small Cell Lung Carcinoma
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.
In addition to the key secondary outcome parameters several potential biomarkers were
evaluated as exploratory parameters.
Issues on safety are addressed in the Adverse Event section.
The following acronyms and abbreviations were used in the Adverse Event section and
Limitations and Caveats section:
- gastrointestinal (GI)
- not otherwise specified (NOS)
- central nervous system (CNS)
- National Cancer Institute Common Terminology Criteria (NCI-CTC)
- Medical Dictionary for Regulatory Activities (MedDRA)
- System Organ Class (SOC)
- interim analysis (IA)
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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