Trials / Recruiting
RecruitingNCT06479135
Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- Sponsor
- Kartos Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Navtemadlin | Navtemadlin is an investigational MDM2 inhibitor |
| DRUG | Navtemadlin placebo | Navtemadlin placebo |
| DRUG | Ruxolitinib | Ruxolitinib is a janus kinase 1/2 inhibitor |
Timeline
- Start date
- 2024-06-03
- Primary completion
- 2026-12-31
- Completion
- 2028-12-31
- First posted
- 2024-06-28
- Last updated
- 2025-09-25
Locations
215 sites across 19 countries: United States, Australia, Austria, Belgium, Croatia, Czechia, France, Georgia, Germany, Greece, Hungary, Italy, Poland, Portugal, Romania, Serbia, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06479135. Inclusion in this directory is not an endorsement.