Status:
COMPLETED
MEK162 for Patients With RAS/RAF/MEK Activated Tumors
Lead Sponsor:
Pfizer
Conditions:
Solid Tumor and Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 warr...
Detailed Description
This is a phase II, open label study to determine the efficacy and safety of treatment with MEK162 in patients with a diagnosis of select solid tumors or hematological malignancies that have been pre-...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 10 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2017
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01885195
Start Date
October 10 2013
End Date
April 11 2017
Last Update
February 21 2021
Active Locations (68)
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1
University of South Alabama / Mitchell Cancer Institute Univ South Alabama
Mobile, Alabama, United States, 36688
2
Alaska Oncology and Hematology AOH (2)
Anchorage, Alaska, United States, 99508
3
Arizona Oncology Associates AZ Oncology Assoc.
Phoenix, Arizona, United States
4
Arizona Oncology Associates HOPE Division
Phoenix, Arizona, United States