This is a Phase 2, multicenter, two-arm, open-label study to evaluate the safety and efficacy of selinexor versus treatment per physician's choice (PC) in participants with myelofibrosis (MF) who had at least 6 months of treatment with a Janus kinase (JAK)1/2 inhibitor. Study participants will be randomized in a 1:1 ratio to either receive selinexor or physicians' choice of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
112
Unit Dose Strength: 20 mg; Dose Formulation: Tablet; Dosage Level: 60 or 80 mg, QW; Route of Administration: Oral
Physician's choice treatment may include ruxolitinib retreatment, fedratinib, chemotherapy (e.g., hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulatory agent, androgen, interferon (all as per clinical practice) and may include supportive care only with no MF treatment; no investigational therapies are allowed.
The Oncology Institute of Hope and Innovation
Pasadena, California, United States
Percentage of Participants with Spleen Volume Reduction of Greater Than or Equal to (≥) 35 Percent (%) (SVR35)
Time frame: From Baseline up to Week 24
Percentage of Participants with Total Symptom Score Reduction of ≥50% (TSS50) Measured by Myelofibrosis Symptom Assessment Form (MFSAF) V4.0, Based on Local Assessment
Time frame: From Baseline up to Week 24
Percentage of Participants with Spleen Volume Reduction of ≥25% (SVR25)
Time frame: From Baseline up to Week 24
Overall Survival (OS)
Time frame: From Baseline up to 12 months after end of treatment (approximately 48 months)]
Percentage of Participants with Anemia Response Assessed by International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)
Time frame: From Baseline up to 28 days after last dose (approximately 48 months)
Duration of Spleen Volume Reduction of ≥35% (SVR35)
Time frame: From Baseline up to Week 24
Duration of Spleen Volume Reduction of ≥25% (SVR25)
Time frame: From Baseline up to Week 24
Duration of Total Symptom Score is ≥50% (TSS50) Based on Local Assessment
Time frame: From Baseline up to Week 24
Overall Response Rate (ORR) Assessed by IWG-MRT
Time frame: From Baseline up to 28 days after last dose (approximately 48 months)
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Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, United States
Illinois Cancer Specialist
Niles, Illinois, United States
Texas Oncology - Northeast Texas
Tyler, Texas, United States
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Suzhou University -The First Affiliated Hospital
Suzhou, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
...and 11 more locations
Number of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity Grade ≥3, Serious Adverse event (SAEs), and AEs Leading to Treatment Discontinuation
Time frame: From first dose of study treatment up to 30 days after end of treatment (approximately 48 months)
Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration-time Curve (AUC) of Selinexor
Time frame: Cycle 2 Day 1: 1, 2, 4, and 6 hours post-dose; Cycle 2 Day 2: at 24 hours post-dose (each cycle is 28 days)
PK Parameter: Maximum Plasma Concentration (Cmax) of Selinexor
Time frame: Cycle 2 Day 1: 1, 2, 4, and 6 hours post-dose; Cycle 2 Day 2: at 24 hours post-dose (each cycle is 28 days)