A Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis
- Conditions
- MyelofibrosisMedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-001398-17-ES
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 164
- 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
- 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.
- Subject has palpable splenomegaly.
- Subject must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol.
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
- 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.
- Subject has received strong or moderate CYP3A inhibitors within 14 days prior to the administration of the first dose of navitoclax.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>- To evaluate the effect of navitoclax alone or in combination with ruxolitinib on bone marrow fibrosis<br>- To determine the overall response rate (ORR = sum of rates of complete remission [CR] + partial remission [PR]) associated with navitoclax alone or in combination with ruxolitinib<br>- To determine the rate of anemia response associated with navitoclax alone or in combination with ruxolitinib<br>- To describe the safety profile and PK profile observed with navitoclax alone or in combination with ruxolitinib;Primary end point(s): The percent of subjects who achieve = 35% spleen volume reduction (SVR35) at Week 24 measured by MRI.;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary endpoints are percent change in TSS; ORR; anemia response; and change in grade of bone marrow fibrosis.;Timepoint(s) of evaluation of this end point: Week 24