Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib

Condition(s) studied

Investigational drug(s) / intervention(s)

Navtemadlin: Navtemadlin is an investigational MDM2 inhibitor

Navtemadlin placebo: Navtemadlin placebo

Ruxolitinib: Ruxolitinib is a janus kinase 1/2 inhibitor

Study 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.

Eligibility

Primary outcome measure(s)

• To compare spleen volume reduction (SVR35) between Arm 1 and Arm 2 — 24 weeks
  The proportion of subjects in each arm with SVR35 by MRI/CT scan (central review) 24 weeks after start of the randomized period
• To compare total symptom score reduction (TSS50) between Arm 1 and Arm 2 — 24 weeks
  The proportion of subjects in each arm with a TSS50 by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0 24 weeks after start of the randomized period

Trial sites (215)

+ 175 more sites — see the full list on the official registry below.

On this site

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