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

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ClinicalTrials.gov Identifier: NCT03222609
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myelofibrosis (MF) Drug: Navitoclax Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Single-Arm, Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax in Combination With Ruxolitinib in Subjects With Myelofibrosis
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : March 25, 2020
Estimated Study Completion Date : June 11, 2021


Arm Intervention/treatment
Experimental: Navitoclax + ruxolitinib
Navitoclax once daily (QD) at various doses added to current stable dose of ruxolitinib twice daily (BID).
Drug: Navitoclax
Tablet; navitoclax QD various doses added to ruxolitinib BID at participants current stable dose (greater than or equal to 10 mg) until end of clinical benefit or occurrence of unacceptable toxicity or discontinuation criteria have been met.
Other Name: navitoclax also known as ABT-263 ruxolitinib also known as Jakafi




Primary Outcome Measures :
  1. Percent Change in Splenic Volume from baseline [ Time Frame: Up to approximately 96 weeks ]
    Evaluate the effect of the addition of navitoclax to ruxolitinib on spleen volume as assessed by magnetic resonance imaging (MRI)


Secondary Outcome Measures :
  1. Anemia Response Rate [ Time Frame: Every 12 weeks up to approximately 96 weeks ]
    The rate of anemia response will be assessed according to current International Working Group-Myeloproliferative Neoplasms Research and European LeukemiaNet (IWG-MRT/ELN) criteria

  2. Change in Degree of Bone Marrow Fibrosis [ Time Frame: Evaluated at Week 12, 24, 48 and 96 ]
    Change in degree of bone marrow fibrosis from baseline as assessed by bone marrow biopsy.

  3. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Week 0 Day 1 ]
    Maximum Observed Plasma Concentration (Cmax)

  4. Percent Change in Total System Score (TSS) [ Time Frame: Up through Week 24 ]
    TSS is assessed by the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0.

  5. Time to Cmax (peak time, Tmax) [ Time Frame: Week 0 Day 1 ]
    Tmax defined as time to maximum observed plasma concentration.

  6. Overall Response Rate [ Time Frame: Up to approximately 96 weeks ]
    To determine the overall response rate (ORR defined as the sum of rates of complete remission [CR] + partial remission [PR]) associated with the addition of navitoclax to ruxolitinib according to the IWG criteria

  7. Area Under the Plasma Concentration-time Curve from time 0 to the time of the last measurable concentration (AUCt) [ Time Frame: Week 0 Day 1 ]
    Area under the plasma concentration-time curve from time zero to the last measureable concentration



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222609


Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
United States, Alabama
UAB Comprehensive Cancer Cente /ID# 165464 Recruiting
Birmingham, Alabama, United States, 35217
United States, California
Ucsd /Id# 164084 Recruiting
La Jolla, California, United States, 92037
Usc /Id# 164095 Recruiting
Los Angeles, California, United States, 90033
United States, Florida
Mayo Clinic /ID# 164201 Recruiting
Jacksonville, Florida, United States, 32224
Moffitt Cancer Center /ID# 164082 Recruiting
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago /ID# 164115 Recruiting
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana Blood & Marrow Transpl /ID# 165075 Recruiting
Indianapolis, Indiana, United States, 46237
United States, Massachusetts
Dana-Farber Cancer Institute /ID# 162675 Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Hospital /ID# 162682 Recruiting
Detroit, Michigan, United States, 48202
United States, New York
Weill Cornell Medical College /ID# 162679 Recruiting
New York, New York, United States, 10021
United States, Texas
MD Anderson Cancer Center /ID# 162683 Recruiting
Houston, Texas, United States, 77030
UT Health Cancer Center /ID# 164094 Recruiting
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah /ID# 164116 Recruiting
Salt Lake City, Utah, United States, 84112-5500
United Kingdom
Guy's and St Thomas' NHS Found /ID# 164110 Recruiting
London, London, City Of, United Kingdom, SE1 9RT
Christie NHS Foundation Trust /ID# 164111 Recruiting
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03222609     History of Changes
Other Study ID Numbers: M16-109
2017-001398-17 ( EudraCT Number )
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
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

Additional relevant MeSH terms:
Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Navitoclax
Antineoplastic Agents