Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Jonsson Comprehensive Cancer Center
With
PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of increasing doses of MEK162 (binimetinib) with docetaxel 75 mg/m2 every 21 days in patients with stage IV non-small cell lung cancer (NSCLC) that have progressed after at least one prior systemic therapy. SECONDARY OBJECTIVES: I. Determine objective tumor response rate (RR) as defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 with MEK162 and standard doses of docetaxel in stage IV NSCLC. II. Determine progression free survival (PFS) of MEK162 and standard doses of docetaxel. III. Evaluate the pharmacokinetic profile of MEK162 when given along with docetaxel. TERTIARY OBJECTIVES: I. Evaluate tissue biomarkers in baseline tumors and at the time of progression to correlate with clinical outcome II. Assess the activation status of extracellular signal-regulated kinase (ERK), protein kinase B (Akt) and ribosomal protein S6 kinase (S6K) in tumor biopsy samples at baseline and at the time of progression. III. Determine the cytokine profile before and after treatment in patients. OUTLINE: This is a dose-escalation study of binimetinib. Patients receive binimetinib orally (PO) twice daily (BID) on days 1-21 and docetaxel intravenously (IV) on day 21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who have stable disease or better after completing 6 courses of binimetinib and docetaxel may continue receiving binimetinib PO BID in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then annually for up to 5 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
