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A Phase 2 Single-Arm, Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax in Combination with Ruxolitinib in Subjects with Myelofibrosis

Clinical Trial Details

Navitoclax is an investigational agent that inhibits a family of BCL proteins. These proteins block some of the enzymes that keep cancer cells from dying and by inhibiting these proteins, navitoclax may cause the cancer cells to die. 
    
Ruxolitinib is approved by the FDA for the treatment of myelofibrosis. Ruxolitinib blocks a protein called Janus-associated kinases (JAK) which may help keep abnormal blood cells or cancer cells from growing. 
    
The purpose of this study is to evaluate the addition of navitoclax to ruxolitinib in patients who have been receiving ruxolitinib alone. Ruxolitinib treatment alone has not been fully controlling disease which is evident by an enlarged spleen. Preclinical data suggest that the combination of navitoclax with ruxolitinib are synergistic and that navitoclax may help to overcome disease resistance to ruxolitinib. 
    
The study will help to determine the effect of the combination of navitoclax plus ruxolitinib on your cancer. The study will evaluate how the efficacy and safety of the drug. 

Key Eligibility: 

- 18 years of age or older. 
- Documented diagnosis of primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis. 
- Ineligible or unwilling to undergo stem cell transplantation at time of study entry. 
- Received ruxolitinib therapy for at least 24 weeks and be currently on a stable dose of at least 10 mg BID of ruxolitinib for at least 8 weeks prior to the first dose of navitoclax. 
- Must have splenomegaly (enlarged spleen). 

   *Detailed eligibility criteria will be reviewed when you contact the study team. 

Contact

Tania Curcio
tjc9003@med.cornell.edu
(212) 746-2571

Primary Investigator

Ellen K. Ritchie, M.D.

Protocol ID(s)

Weill Cornell Medicine IRB #:

1706018294

Sponsor:

AbbVie M16-109

ClinicalTrials.gov:

NCT03222609

Status:

Open to Enrollment

Age Group

Adult

Sponsor

Disease

Drug/Device

Drug

Study Type

Phase

2