A Phase II Study of Sorafenib (BAY 43-9006) in Recurrent Aggressive Non-Hodgkin's Lymphoma
PRIMARY OBJECTIVES:
I. To evaluate the response rate of treatment with sorafenib (BAY43-9006) in patients with
recurrent aggressive non-Hodgkin's lymphomas.
SECONDARY OBJECTIVES:
I. To evaluate the duration of response and progression free survival of treatment with
BAY43-9006 in patients with recurrent aggressive Non-Hodgkin's Lymphomas.
II. To characterize the toxicity of treatment with BAY43-9006 in patients with recurrent
aggressive Non-Hodgkin's Lymphomas.
III. To further characterize the pharmacokinetics properties of BAY43-9006 and assess
influence of monooxygenases polymorphisms and MDR on pharmacokinetics.
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 1 year.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate based on the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma
Up to 3 years
No
Sandra Horning
Principal Investigator
Eastern Cooperative Oncology Group
United States: Food and Drug Administration
NCI-2012-02955
NCT00131937
October 2005
Name | Location |
---|---|
Eastern Cooperative Oncology Group | Boston, Massachusetts 02215 |