At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of PMF, post-PV MF, or post-ET MF per WHO criteria
- ✓High, Intermediate-1, or Intermediate-2 risk IPSS (ruxolitinib alone period)
- ✓ECOG performance status 0 to 2
- ✓JAK-inhibitor treatment naive
- ✕Prior splenectomy
- ✕Splenic irradiation within 3 months prior to first dose
- ✕Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors or p53-directed therapy
- ✕Eligible for bone marrow transplant
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Navtemadlin, Navtemadlin placebo, and 1 other intervention for Myelofibrosis and 4 related conditions. Currently recruiting, targeting 600 participants across 215 sites in 19 countries.
Signals
Detailed Summary
This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone. Subjects will start by receiving ruxolitinib alone in the run-in period. Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 2:1 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib. Randomized means that subjects will be assigned to a group by chance, like a flip of a coin. The study is blinded, meaning the subjects, doctors, central endpoint assessors and sponsor will not know which add on treatment (navtemadlin or navtemadlin placebo) the subject is receiving.
Study Details
Timeline
Interventions
Navtemadlin is an investigational MDM2 inhibitor
Navtemadlin placebo
Ruxolitinib is a janus kinase 1/2 inhibitor