A Phase 2, Open Label Study of REC-4881 in Participants with Unresectable Locally Advanced or Metastatic Cancer with AXIN1 or APC Mutation

MC #23-29

NCT #
Condition(s)
Colorectal Cancer, Solid Tumor
Molecular Target(s)
MEK
Drug Classification(s)
Molecular Targeted Therapy
Agents(s)
REC-4881
Phase(s)
II

Mechanism of Action

  • REC-4881 is a MEK inhibitor

Purpose

In this study, the sponsor and investigators want to learn:

  • How much of the study drug can be given with an acceptable level of side effects
  • The effects of the study drug (good and bad)
  • How much of the study drug is absorbed into the blood and how fast it is removed
  • How the study drug is acting on your body

Study Design

The dose of the study drug you receive has been predetermined to begin at 12 mg but your dose may decrease depending on your doctor’s order. Your study doctor will tell you which dose you will be taking.

The study regimen will be given every day by mouth. You will come into the clinic for your first dose the first week, then every 2 weeks until week 9, then every 4 weeks for up to 2 years. On days when you will receive your study drug in the clinic, you will not be allowed to eat anything for at least 2 hours after taking the study drug.

Some days you will take the study drug at home and some days you will take study drug at the study site. On days when you have a study visit at the site, dosing will occur at the site under supervision of site staff. You will be expected to bring your supply of study drug, including any unused, used, and empty blister pack(s) to the site for each study visit.

You will take up to 3 capsules daily for up to 2 years and you will store the study drug in a secure location at room temperature.

Location

Mary Crowley Cancer Research - Medical City Dallas

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