A Single-Arm Phase II Clinical Trial With the Novel MEK Inhibitor AZD-6244 for the Treatment of MCT-1 Related Relapsed or Refractory Diffuse Large B-Cell Lymphoma
I. To evaluate the overall response rate (combined complete remission [CR] and partial
remission [PR]) of AZD6244 hyd-sulfate anti-MEK (selumetinib) therapy for patients with
relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
I. To evaluate the safety and tolerability of MEK inhibitor therapy. II. To determine the
progression-free survival, time to treatment failure, duration of response, and overall
survival with AZD6244 hyd-sulfate therapy.
III. To examine biomarkers through down-regulation of pERK and several relevant target
substrates (e.g., MCT-1, MNK, ELK, c-MYC, and HIF-1alpha) in peripheral blood studies.
OUTLINE: This is a multicenter study.
Patients receive selumetinib orally (PO) twice daily on days 1-28. Treatment repeats every
28 days for 8 courses in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample and tumor tissue collection at baseline and at day 15 of
course 1 for biomarker studies.
After completion of study therapy, patients are followed up every 3 months for up to 3
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (complete response and partial response) in patients treated with selumetinib
Estimates of the response rate based on best response [complete response (CR), and partial response (PR)] and the tumor control rate [CR, PR, and stable disease (SD)] will be provided together with the exact two-sided 95% confidence intervals.
Up to 3 years
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|Ingalls Memorial Hospital||Harvey, Illinois 60426|
|Weill Medical College of Cornell University||New York, New York 10021|
|Northwestern University||Chicago, Illinois 60611|
|University of Massachusetts Medical School||Worcester, Massachusetts 01605|
|Indiana University Medical Center||Indianapolis, Indiana 46202|
|Decatur Memorial Hospital||Decatur, Illinois 62526|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|Evanston CCOP-NorthShore University HealthSystem||Evanston, Illinois 60201|
|Illinois CancerCare-Peoria||Peoria, Illinois 61615|
|Fort Wayne Medical Oncology and Hematology Inc - State Boulevard||Fort Wayne, Indiana 46845|
|Saint John's Mercy Medical Center||Saint Louis, Missouri 63141|
|University of Maryland Greenebaum Cancer Center||Baltimore, Maryland 21201|
|University of Michigan University Hospital||Ann Arbor, Michigan 48109|
|Saint Joseph Medical Center||Towson, Maryland 21204|
|Southern Illinois University||Springfield, Illinois 62702|