Purpose

This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of navitoclax alone or when added to ruxolitinib in participants with myelofibrosis.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants with documented diagnosis of intermediate or high-risk primary Myelofibrosis, post polycythemia Vera Myelofibrosis or post-essential thrombocythemia myelofibrosis
  • Participant must be ineligible or unwilling to undergo stem cell transplantation at time of study entry
  • ECOG of 0,1, or 2.
  • Participant 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.
  • Participant has splenomegaly as defined in the protocol.
  • Participant must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol.

Exclusion Criteria

  • Splenic irradiation within 6 months prior to screening, or prior splenectomy.
  • Leukemic transformation (> 10% blasts in peripheral blood or bone marrow biopsy).
  • Participant 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.
  • Participant has received strong or moderate CYP3A inhibitors within 14 days prior to the administration of the first dose of navitoclax.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Navitoclax + ruxolitinib
Participants will be administered navitoclax once daily (QD) at various doses and a dose greater than or equal to 10 mg of ruxolitinib twice daily (BID).
  • Drug: Ruxolitinib
    Tablet; Oral
    Other names:
    • Jakafi
  • Drug: Navitoclax
    Tablet; Oral
    Other names:
    • ABT-263
Experimental
Navitoclax
Participants will be administered various doses of navitoclax once daily (QD)
  • Drug: Ruxolitinib
    Tablet; Oral
    Other names:
    • Jakafi
  • Drug: Navitoclax
    Tablet; Oral
    Other names:
    • ABT-263

Recruiting Locations

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
847.283.8955
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.