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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

Call 813-745-6100
or 1-800-679-0775
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.
  • Prior therapy with BH3 mimetric compound.
  • Patient has a history of an active malignancy other than MF within the past 2 years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri, adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin, Asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy.
  • Patients has known positive test for HIV.
  • Patient has chronic active hepatitis B or hepatitis C requiring treatment.
  • Patient exhibits evidence of other clinically significant uncontrolled condition(s).
  • Patient has received any of the following within 14 days prior to the first dose of study drug: Strong or moderate CYP3A inhibitors, strong or moderate CYP3A inducers.
  • Women who are pregnant, breast feeding, or considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug. Men who are considering fathering a child or donating sperm during the study or for approximately 90 days after the last dose of study drug.
  • Patient has a history of cardiovascular, endocrinologic, hepatic, immunologic metabolic, neurologic, psychiatric, pulmonary, renal disease, or any other condition that in the opinion of the investigator would adversely affect his/her participation in this study for interpretation of study results.
  • Patient is concurrently participating in another therapeutic clinical trial.