Ph 3 Study in MF of Navtemadlin vs Placebo as Add-on Therapy to Rux (Myelofibrosis)

Ph 3 Study in MF of Navtemadlin vs Placebo as Add-on Therapy to Rux (Myelofibrosis)

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Purpose of this Study

We are doing this study to find out if an experimental drug called navtemadlin (the study drug) is a safe and effective option for people with myelofibrosis (MF). We want to know how well it works when it is combined with ruxolitinib for people who did not get the desired results from ruxolitinib on its own.

Who Can Participate?

Eligibility

Adults ages 18+ who:
  • Are diagnosed with PMF, post-PV MF, or post-ET MF
  • Received previous treatment with ruxolitinib and did not have an optimal response
  • Have not received previous treatment with any of the following: JAK inhibitor, BCL-XL, BET, MDM2, PI3K, PIM, XPO1 inhibitors; or any p53-directed therapy
For more information about who can join this study, please contact the study team at 919-668-2556.

What is Involved?

Description

If you choose to join this study and are found to be eligible after a brief screening period, you will begin by taking ruxolitinib on its own for 18-24 weeks. If you continue to be eligible after this period, you will get a random assignment to 1 of 2 groups:
  • Group 1: If you are in this group, you will take 240mg dose of the study drug once per day for 7 days (Days 1-7) followed by 21 days of not taking the study drug. You will continue to take ruxolitinib daily at the dose determined by your doctor. Each of these 28-day periods is called a "cycle."
  • Group 2: If you are in this group, you will take a dose of placebo (inactive substance that has no drug in it) once per day for 7 days (Days 1-7) followed by 21 days of not taking it. You will continue to take ruxolitinib daily at the dose determined by your doctor.
The number of cycles you complete in the study will depend on how well you respond to your assigned regimen. You can also choose to stop participating at any time. The odds that you will get an assignment to get the study drug is 2:1. This means that you are twice as likely to be taking the study drug compared to the placebo.

Study Details

Full Title

A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Principal Investigator

Lindsay
Rein

Protocol Number

PRO00116041

NCT ID

NCT06479135

Phase

III

Enrollment Status

Pending Open to Enrollment
ClinicalTrials.gov