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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

July 17, 2017
July 19, 2017
September 17, 2018
October 31, 2017
March 25, 2020   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT03222609 on ClinicalTrials.gov Archive Site
  • 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
  • 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.
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Week 0 Day 1 ]
    Maximum Observed Plasma Concentration (Cmax)
  • 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.
  • Time to Cmax (peak time, Tmax) [ Time Frame: Week 0 Day 1 ]
    Tmax defined as time to maximum observed plasma concentration.
  • 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
  • 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
  • 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.
  • 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
  • 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.
  • 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
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Week 1 Day 1 ]
    Maximum Observed Plasma Concentration (Cmax)
  • Time to Cmax (peak time, Tmax) [ Time Frame: Week 1 Day 1 ]
    Tmax defined as time to maximum observed plasma concentration.
  • Area Under the Plasma Concentration-time Curve from time 0 to the time of the last measurable concentration (AUCt) [ Time Frame: Week 1 Day 1 ]
    Area under the plasma concentration-time curve from time zero to the last measureable concentration
Not Provided
Not Provided
 
A Study Evaluating Tolerability and Efficacy of Navitoclax in Combination With Ruxolitinib in Subjects With Myelofibrosis
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Myelofibrosis (MF)
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
Experimental: Navitoclax + ruxolitinib
Navitoclax once daily (QD) at various doses added to current stable dose of ruxolitinib twice daily (BID).
Intervention: Drug: Navitoclax
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
34
Same as current
June 11, 2021
March 25, 2020   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
United Kingdom,   United States
 
 
NCT03222609
M16-109
2017-001398-17 ( EudraCT Number )
No
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
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: 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
AbbVie
AbbVie
Not Provided
Study Director: AbbVie Inc. AbbVie
AbbVie
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP