A PHASE 1/3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SELINEXOR, A SELECTIVE INHIBITOR OF NUCLEAR EXPORT, IN COMBINATION WITH RUXOLITINIB IN TREATMENT-NAÏVE PATIENTS WITH MYELOFIBROSIS

Conditions

Treatment naïve patients with MF

Brief summary

Proportion of patients with spleen volume reduction (SVR) of ≥35% (SVR35) at Week 24 as measured by MRI or CT scan by Investigator assessment, Absolute mean change in TSS (Abs-TSS) from baseline to Week 24 as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0a

Detailed description

Proportion of patients with SVR35 at Week 48 as measured by MRI or CT scan by Investigator assessment, Overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause., PFS as defined in the statistical analysis plan (SAP), Proportion of patients with SVR35 at any time point in the study as measured by MRI or CT scan., Absolute mean change in TSS (Abs-TSS) from baseline to Week 48 as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0a, Incidence and severity of TEAEs including treatment-related adverse events (TRAEs), SAEs., PK endpoints including but not limited to AUC, Cmax, and Tmax., Proportion of patients with at least a 1-grade decrease in bone marrow fibrosis at any point in the study., Progression-free survival (PFS)

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGJakavi 5 mg tablets

DRUGJakavi 15 mg tablets

DRUGAkynzeo 300 mg/0.5 mg hard capsules

DRUGEMEND 125 mg+80 mg hard capsules

DRUGSelinexor placebo for 20 mg tablets formulated for oral administration.

DRUGJakavi 20 mg tablets

DRUGPALONOSETRON

DRUGONDANSETRON ZYDUS 8 mg

DRUGcomprimé orodispersible

DRUGSELINEXOR

DRUGONDANSETRON

DRUGJakavi 10 mg tablets

DRUGNETUPITANT

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of patients with spleen volume reduction (SVR) of ≥35% (SVR35) at Week 24 as measured by MRI or CT scan by Investigator assessment, Absolute mean change in TSS (Abs-TSS) from baseline to Week 24 as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0a	—

Secondary

Measure	Time frame
Proportion of patients with SVR35 at Week 48 as measured by MRI or CT scan by Investigator assessment, Overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause., PFS as defined in the statistical analysis plan (SAP), Proportion of patients with SVR35 at any time point in the study as measured by MRI or CT scan., Absolute mean change in TSS (Abs-TSS) from baseline to Week 48 as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0a, Incidence and severity of TEAEs including treatment-related adverse events (TRAEs), SAEs., PK endpoints including but not limited to AUC, Cmax, and Tmax., Proportion of patients with at least a 1-grade decrease in bone marrow fibrosis at any point in the study., Progression-free survival (PFS)	—

Measure

Time frame

Proportion of patients with SVR35 at Week 48 as measured by MRI or CT scan by Investigator assessment, Overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause., PFS as defined in the statistical analysis plan (SAP), Proportion of patients with SVR35 at any time point in the study as measured by MRI or CT scan., Absolute mean change in TSS (Abs-TSS) from baseline to Week 48 as measured by the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0a, Incidence and severity of TEAEs including treatment-related adverse events (TRAEs), SAEs., PK endpoints including but not limited to AUC, Cmax, and Tmax., Proportion of patients with at least a 1-grade decrease in bone marrow fibrosis at any point in the study., Progression-free survival (PFS)

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Countries

Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Romania, Spain

Outcome results

None listed