MEK162 for Patients With RAS/RAF/MEK Activated Tumors

• Status: Completed
• Trial end date: 2017-04-11
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this signal seeking study is to determine whether treatment with MEK162 demonstrates sufficient efficacy in select pathway-activated solid tumors and/or hematologic malignancies to warrant further study

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Array BioPharma; Pfizer

Criteria

Inclusion Criteria:

• Patient has a confirmed diagnosis of a select solid tumor (except for primary diagnosis of pancreatic cancer, biliary cancer, colorectal cancer, low grade serous ovarian cancer, melanoma) or hematologic malignancy (except for primary diagnosis of chronic myelomonocytic leukemia).

• Patients must be pre-identified as having a tumor with a mutation in RAF, RAS, NF1 or MEK at a CLIA certified laboratory

• Patient must have received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.

• Patient must have progressive and measurable disease as per RECIST 1.1. or other appropriate hematological guidelines.

• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

• Patient has received prior treatment with MEK162.

• Patients with primary CNS tumor or CNS tumor involvement

• History of retinal degenerative disease

• History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO)

• Any ophthalmopathy visible at screening that would be considered a risk factor for CSR or RVO by the ophthalmologist

• Patients who have neuromuscular disorders that are associated with elevated CK