MEK162 for Patients With RAS/RAF/MEK Activated Tumors

Completed · Phase 2

Conditions studied: Solid Tumor and Hematologic Malignancies

In brief

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

Key facts

Study ID

NCT01885195

Run by

Pfizer

People needed

110

Starts

2013-10-10

Expected to finish

2017-04-11

Last updated by the study team

2021-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alaska Oncology and Hematology AOH (2) — Anchorage, Alaska, United States
• Arizona Oncology Associates AZ Oncology Assoc. — Phoenix, Arizona, United States
• Arizona Oncology Associates HOPE Division — Phoenix, Arizona, United States
• Arizona Oncology Associates PC- NAHOA — Sedona, Arizona, United States
• Highlands Oncology Group Highlands Oncology Group (22) — Fayetteville, Arkansas, United States
• PCR Oncology — Pismo Beach, California, United States
• University of California Davis Cancer Center UC Davis Cancer (3) — Sacramento, California, United States
• Rocky Mountain Cancer Centers USOR — Boulder, Colorado, United States
• Yale University School of Medicine Yale Cancer Center — New Haven, Connecticut, United States
• Whittingham Cancer Center Norwalk Hospital — Norwalk, Connecticut, United States
• Eastern Connecticut Hematology & Oncology Associates Dept. of ECHO — Norwich, Connecticut, United States
• Hematology Oncology PC Stamford Hospital — Stamford, Connecticut, United States
• Florida Cancer Specialists Florida Cancer Specialists (31 — Fort Myers, Florida, United States
• Memorial Cancer Institute Memorial Healthcare System — Hollywood, Florida, United States
• Cancer Specialists of North Florida — Jacksonville, Florida, United States
• Mt. Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• Ocala Oncology Center Dept. of Ocala Oncology Center — Ocala, Florida, United States
• Cancer Centers of Florida PA Cancer Centers of FL-Orlando-4 — Ocoee, Florida, United States
• University Cancer & Blood Center, LLC — Athens, Georgia, United States
• Lurie Children's Hospital of Chicago Developmental Therapeutics — Chicago, Illinois, United States
• Oncology Specialists, SC Onc Specialists — Park Ridge, Illinois, United States
• Illinois Cancer Care IL. Cancer Care — Peoria, Illinois, United States
• Indiana University Indiana Univ. - Purdue Univ. — Indianapolis, Indiana, United States
• University of Iowa Hospitals & Clinics Regulatory Contact 2 — Iowa City, Iowa, United States
• University of South Alabama / Mitchell Cancer Institute Univ South Alabama — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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