A Study Evaluating Tolerability and Efficacy of Navitoclax in Combination With Ruxolitinib in Subjects With Myelofibrosis

  • Interventional
  • Recruiting
  • NCT03222609
Eligibility Details Visit Clinicaltrials.gov

A Phase 2 Single-Arm, Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax in Combination With Ruxolitinib in Subjects With Myelofibrosis

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

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Participants with documented diagnosis of 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

         - Participant must have received ruxolitinib therapy for at least 12 weeks and be currently on a stable dose of >= 10 mg BID of ruxolitinib for >= 8 weeks prior to the 1st dose of navitoclax, ECOG of 0,1, or 2.

        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.

At a Glance

National Government IDNCT03222609

IRB#IRB17-1150

Lead SponsorAbbVie

Lead PhysicianOlatoyosi Odenike

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting