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Trial record 1 of 1 for:    M16-109
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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 : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

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

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or 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 : September 20, 2028


Arm Intervention/treatment
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).
Drug: Ruxolitinib
Tablet; Oral
Other Name: Jakafi

Drug: Navitoclax
Tablet; Oral
Other Name: ABT-263

Experimental: Navitoclax
Participants will be administered various doses of navitoclax once daily (QD)
Drug: Navitoclax
Tablet; Oral
Other Name: ABT-263




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

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

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

  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



Information from the National Library of Medicine

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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 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.

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
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03222609    
Other Study ID Numbers: M16-109
2017-001398-17 ( EudraCT Number )
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
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

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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:
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Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Navitoclax
Antineoplastic Agents