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Trial record 1 of 1 for:    NCT03222609
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A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03222609
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE July 17, 2017
First Posted Date  ICMJE July 19, 2017
Last Update Posted Date May 8, 2020
Actual Study Start Date  ICMJE October 31, 2017
Estimated Primary Completion Date May 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
Percentage of Participants who achieve Spleen Volume Reduction of greater than or equal to 35% (SVR35) from baseline [ Time Frame: From Baseline (Week 0) through Week 24 ]
Reduction in spleen volume is measured by magnetic resonance imaging (MRI).
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
  • Percent Change in Total System Score (TSS) [ Time Frame: From Baseline (Week 0) through Week 24 ]
    TSS is assessed by the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0.
  • Overall Response Rate (ORR) [ 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]) according to the IWG criteria.
  • 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)
  • Time to Cmax (peak time, Tmax) [ Time Frame: Week 0 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 0 Day 1 ]
    Area under the plasma concentration-time curve from time zero to the last measureable concentration
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis
Official Title  ICMJE A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Subjects With Myelofibrosis
Brief Summary This is a Phase 2 open-label, multicenter study evaluating tolerability and efficacy of navitoclax alone or when added to ruxolitinib in participants with myelofibrosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myelofibrosis (MF)
Intervention  ICMJE
  • Drug: Ruxolitinib
    Tablet; Oral
    Other Name: Jakafi
  • Drug: Navitoclax
    Tablet; Oral
    Other Name: ABT-263
Study Arms  ICMJE
  • Experimental: Navitoclax + ruxolitinib
    Participants will be administered navitoclax once daily (QD) at various doses and a dose greater than or equal to 10 mg of ruxolitinib twice daily (BID).
    Interventions:
    • Drug: Ruxolitinib
    • Drug: Navitoclax
  • Experimental: Navitoclax
    Participants will be administered various doses of navitoclax once daily (QD)
    Intervention: Drug: Navitoclax
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 10, 2019)
164
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2017)
34
Estimated Study Completion Date  ICMJE February 2, 2029
Estimated Primary Completion Date May 17, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participants with documented diagnosis of intermediate or high-risk 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
  • ECOG of 0,1, or 2.
  • Participant must have either received prior treatment with ruxolitinib OR another JAK-2 inhibitor therapy OR must not have received any prior treatment with JAK-2 inhibitor.
  • Participant has splenomegaly as defined in the protocol.
  • Participant must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol.

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.
  • Prior therapy with a BH3 mimetic compound.
  • Participant has received strong or moderate CYP3A inhibitors within 14 days prior to the administration of the first dose of navitoclax.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Australia,   Canada,   Italy,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03222609
Other Study ID Numbers  ICMJE M16-109
2017-001398-17 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date May 2020

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