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

Phase 3

Recruiting

• Conditions: Myelofibrosis; Post-ET Myelofibrosis; Primary Myelofibrosis; Post-PV MF; MF
• Interventions: Drug: Navtemadlin; Drug: Navtemadlin placebo; Drug: Ruxolitinib

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study Start: 2024-06-03
• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-06-28
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-28
• Last Update Posted: 2024-10-30
• Primary Completion: 2026-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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