Phase II Clinical Trial of the MEK 1/2 Inhibitor AZD6244 in Cancers With BRAF Mutations Identified by Prospective Genotypic Analysis
I. To evaluate the objective response rate to AZD6244 in patients with cancers other than
melanoma in which BRAF mutations have been identified prospectively.
I. To evaluate progression-free survival in subjects treated with AZD6244. II. To obtain a
preliminary estimate of the objective response rate in non-small cell lung cancers and colon
cancers with BRAF mutations.
III. To explore biologic correlates of responsiveness to AZD6244, and specifically to
correlate AKT pathway activity with sensitivity to MEK inhibition in the BRAF mutant class
IV. To estimate the sensitivity and specificity of detection of the BRAF V600E mutation in
circulating tumor cells (CTC) using a microfluidic platform (the 'CTC-chip').
Patients receive selumetinib orally (PO) twice daily (BID) for 3 weeks. Courses repeat every
3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year,
every 6 months for 1 year, and then annually thereafter.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate in patients with cancers other than melanoma
Up to 4 years
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|