Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

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.

Official Title

A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Subjects With Myelofibrosis

Keywords

Myelofibrosis (MF) Post-polycythemia vera MF (PPV-MF) Post-essential thrombocythemia (PET-MF) ruxolitinib navitoclax splenic volume Primary Myelofibrosis Jakafi enlarged spleen splenomegaly ABT 263 bone marrow fibrosis Navitoclax + ruxolitinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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

  • Ucsd /Id# 164084 in progress, not accepting new patients
    La Jolla California 92093 United States
  • Usc /Id# 164095 in progress, not accepting new patients
    Los Angeles California 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT03222609
Phase
Phase 2
Study Type
Interventional
Last Updated