CompletedPhase 2NCT01885195
Official study title

MEK162 for Patients With RAS/RAF/MEK Activated Tumors

Study 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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedMEK162

The study team can explain what participation involves.

Who it may be forSolid Tumor and Hematologic Malignancies

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 21, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?68 U.S. locations

Locations may change over time.

Who runs it?Pfizer

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Pfizer
Interventions being studied
Drug: MEK162
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of South Alabama / Mitchell Cancer Institute Univ South AlabamaMobile, Alabama
  • Alaska Oncology and Hematology AOH (2)Anchorage, Alaska
  • Arizona Oncology Associates AZ Oncology Assoc.Phoenix, Arizona
  • Arizona Oncology Associates HOPE DivisionPhoenix, Arizona
  • Arizona Oncology Associates PC- NAHOASedona, Arizona
  • Highlands Oncology Group Highlands Oncology Group (22)Fayetteville, Arkansas
  • PCR OncologyPismo Beach, California
  • University of California Davis Cancer Center UC Davis Cancer (3)Sacramento, California
  • Rocky Mountain Cancer Centers USORBoulder, Colorado
  • Yale University School of Medicine Yale Cancer CenterNew Haven, Connecticut
  • Whittingham Cancer Center Norwalk HospitalNorwalk, Connecticut
  • Eastern Connecticut Hematology & Oncology Associates Dept. of ECHONorwich, Connecticut

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 21, 2021. Always confirm current availability with the study team.

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