Myelofibrosis MedDRA version: 20.0 Level: PT Classification code 10028537 Term: Myelofibrosis System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects = 18 years of age - Subjects with documented diagnosis of Intermediate or High-risk Primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis - Subjects classified as intermediate-2 or high-risk myelofibrosis, as defined by the Dynamic International Prognostic Scoring System (DIPSS) - Subject must be ineligible or unwilling to undergo stem cell transplantation at time of study entry - Subject must have either received prior treatment with ruxolitinib OR another JAK-2 inhibitor therapy OR must not have received any prior treatment with JAK-2 inhibitor or BET inhibitor. - Subject has palpable splenomegaly - Subject must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol. - Cohorts 1b and 3 only: Subject has at least 2 symptoms each with a score = 3 or a total score of = 12, as measured by the MFSAF v4.0. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: - Splenic irradiation within 6 months prior to screening, or prior splenectomy. - Leukemic transformation (> 10% blasts in peripheral blood or bone marrow biopsy). - Subject is currently on medications that interfere with coagulation (including warfarin) or platelet function with the exception of low dose aspirin (up to 100 mg) and Low-molecular-weight heparin. - Prior therapy with a BH3 mimetic compound. - Cohort 1b only: Subject has received strong or moderate CYP3A inhibitors within 14 days prior to the administration of the first dose of navitoclax.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effect of navitoclax alone or in combination with ruxolitinib on spleen volume;Secondary Objective: - To assess the effect of navitoclax alone or in combination with ruxolitinib on total symptom score (TSS) as assessed by the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0 diary - To evaluate the effect of navitoclax alone or in combination with ruxolitinib on bone marrow fibrosis - To determine the rate of anemia response associated with navitoclax alone or in combination with ruxolitinib - To describe the safety profile and PK profile observed with navitoclax alone or in combination with ruxolitinib ;Primary end point(s): = 35% spleen volume reduction (SVR35) from baseline (SVR35) at week 24 measured by MRI/CT.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are at least 50% reduction in total symptom score from baseline measured by MFSAF 4.0; anemia response; and change in grade of bone marrow fibrosis.;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Australia, Canada, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed