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
City of Hope Medical Center
With
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose (MTD) for the combination of MEK162 (MEK inhibitor MEK162) plus leucovorin calcium, fluorouracil, oxaliplatin (FOLFOX) in patients with metastatic colorectal cancer. SECONDARY OBJECTIVES: I. Describe the safety of the combination of MEK162 across all investigated dose levels. II. Describe the pharmacokinetics of MEK162 and FOLFOX in 6 patients in the expanded MTD cohort. III. Describe any clinical activity to the combination using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. IV. Determine the recommended Phase II dose (RP2D) which may be less than the MTD for both intermittent and continuous dosing of MEK162. OUTLINE: This is a dose-escalation study of MEK inhibitor MEK162. Patients are assigned to 1 of 2 treatment arms. ARM I: Patients receive MEK inhibitor MEK162 orally (PO) twice daily (BID) on days 1-14, and leucovorin calcium intravenously (IV) over 2 hours, oxaliplatin IV over 2 hours, and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive MEK inhibitor MEK162 PO BID on days 1-5, and leucovorin calcium IV over 2 hours, oxaliplatin IV over 2 hours, and fluorouracil IV continuously over 46 hours on days 6 and 7. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
