An Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis

Phase 1

Active, not recruiting

• Conditions: Myelofibrosis; MedDRA 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-GB
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-27
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 164

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified