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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
600
Navtemadlin is an investigational MDM2 inhibitor
Navtemadlin placebo
Ruxolitinib is a janus kinase 1/2 inhibitor
UAB Hospital
Birmingham, Alabama, United States
RECRUITINGBanner MD Anderson Cancer Center
Gilbert, Arizona, United States
RECRUITINGMayo Clinic - Phoenix
Phoenix, Arizona, United States
RECRUITINGUC San Diego Moores Cancer Center
La Jolla, California, United States
To compare spleen volume reduction (SVR35) between Arm 1 and Arm 2
The proportion of subjects in each arm with SVR35 by MRI/CT scan (central review) 24 weeks after start of the randomized period
Time frame: 24 weeks
To compare total symptom score reduction (TSS50) between Arm 1 and Arm 2
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
Time frame: 24 weeks
To compare time to progression between Arm 1 and Arm 2
Time to progression or death from any cause in subjects randomized to each arm
Time frame: Up to 8 years
To compare overall survival (OS) between Arm 1 and Arm 2
Time to death from any cause in subjects randomized to each arm
Time frame: Up to 8 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
UCLA Hematology/Oncology Clinic - Los Angeles
Los Angeles, California, United States
RECRUITINGScripps Health, Prebys Cancer Center
San Diego, California, United States
RECRUITINGThe Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, United States
RECRUITINGRocky Mountain Cancer Centers - Aurora
Aurora, Colorado, United States
RECRUITINGMedical Oncology Hematology Consultants, PA
Newark, Delaware, United States
RECRUITINGMedStar Georgetown University Hospital, Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
RECRUITING...and 205 more locations