A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis

Status: Active

Description

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.

Eligibility Criteria

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.

Locations & Contacts

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: Active
Contact: Christine Duran
Phone: 323-865-0371
Email: Duran_C@med.usc.edu

Florida

Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Tampa
Moffitt Cancer Center
Status: Active
Contact: Rami S. Komrokji
Phone: 813-745-4291
Email: rami.komrokji@moffitt.org

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Abbvie

Trial IDs

Primary ID M16-109
Secondary IDs NCI-2017-01899, 2017-001398-17
Clinicaltrials.gov ID NCT03222609