Study of Navtemadlin Add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
- Conditions
- Interventions
- Registration Number
- NCT06479135
- Lead Sponsor
- Kartos Therapeutics, Inc.
- Brief 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.
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Navtemadlin Navtemadlin administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day. Arm 2 Navtemadlin placebo Navtemadlin placebo administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day. Arm 1 Ruxolitinib Navtemadlin administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day. Arm 2 Ruxolitinib Navtemadlin placebo administered orally once daily on Days 1-7, off treatment on Days 8-28, in 28-day treatment cycles. Ruxolitinib administered orally twice a day.
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method To compare time to progression between Arm 1 and Arm 2 Up to 8 years Time to progression or death from any cause in subjects randomized to each arm
To compare overall survival (OS) between Arm 1 and Arm 2 Up to 8 years Time to death from any cause in subjects randomized to each arm
Trial Locations
- Locations (30)
Mission Cancer + Blood
🇺🇸Des Moines, Iowa, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Nebraska Hematology - Oncology, P.C.
🇺🇸Lincoln, Nebraska, United States
Cayuga Medical Center at Ithaca
🇺🇸Ithaca, New York, United States
Fairview Hospital - Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Independence Family Health Center - Cleveland Clinic
🇺🇸Independence, Ohio, United States
Hillcrest Hospital - Cleveland Clinic
🇺🇸Mayfield Heights, Ohio, United States
Tennessee Oncology
🇺🇸Nashville, Tennessee, United States
MDACC San Antonio
🇺🇸San Antonio, Texas, United States
Northwest Medical Specialties, PLLC - Tacoma
🇺🇸Tacoma, Washington, United States
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
JSC Vian
🇬🇪Kutaisi, Georgia
JSC German Hospital
🇬🇪Tbilisi, Georgia
LEPL The First University Clinic of Tbilisi State Medical University
🇬🇪Tbilisi, Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
🇬🇪Tbilisi, Georgia
JSC K. Eristavi National Center of Experimental and Clinical Surgery
🇬🇪Tbilisi, Georgia
Caucasus Medical Centre LLC
🇬🇪Tbilisi, Georgia
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Clinical Center of Vojvodina
🇷🇸Novi Sad, Serbia
University Hospital Virgen de la Victoria
🇪🇸Malaga, Spain
Gloucestershire Royal Hospital
🇬🇧Gloucester, United Kingdom
The Clatterbridge Cancer Center NHS Foundation Trust
🇬🇧Liverpool, United Kingdom
American Oncology Partners of Maryland, PA
🇺🇸Bethesda, Maryland, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States