A Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination With Ruxolitinib in Participants With Myelofibrosis
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|ClinicalTrials.gov Identifier: NCT03222609|
Recruitment Status : Recruiting
First Posted : July 19, 2017
Last Update Posted : December 11, 2019
|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 ...
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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).
Other Name: Jakafi
Other Name: ABT-263
Participants will be administered various doses of navitoclax once daily (QD)
Other Name: ABT-263
- 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).
- 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
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
|Contact: ABBVIE CALL CENTERemail@example.com|
|Study Director:||AbbVie Inc.||AbbVie|