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Clinical Trial 19429

Cancer Type:
Interventions:ABT-263 (Navitoclax); Jakafi (Ruxolitinib); Navitoclax; Ruxolitinib

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Rami Komrokji

Overview

Study Title

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

Summary

The purpose of this study is to determine the effect of the combination of navitoclax plus ruxolitinib on your cancer Myelofibrosis. The study will evaluate how well the study drug works and the safety of the drug.

Objective

The Primary Objective of the study is to: Evaluate the effect of the addition of navitoclax to ruxolitinib on spleen volume. The Secondary Objectives of the study are: To assess the effect of the addition of navitoclax to ruxolitinib on total symptom score (TSS) as assessed by the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0 diary. To evaluate the effect of the addition of navitoclax to ruxolitinib on bone marrow fibrosis. To determine the overall response rate (ORR = sum of rates of complete remission [CR] + partial remission [PR]) associated with the addition of navitoclax to ruxolitinib. To determine the rate of anemia response associated with the addition of navitoclax to ruxolitinib. To describe the safety profile and PK profile observed with the addition of navitoclax to ruxolitinib.

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 24 weeks and be currently on a stable dose of >= 10 mg two times a day (BID) of ruxolitinib for >= 8 weeks prior to the 1st dose of navitoclax, Eastern Cooperative Oncology Group (ECOG) of 0,1, or 2.

    • Exclusion Criteria

  • Splenic irradiation within 12 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.

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