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Jakafi (Ruxolitinib) - Summary



Ruxolitinib phosphate is a kinase inhibitor.


Jakafi is indicated for treatment of patients with intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis.

Polycythemia Vera

Jakafi is indicated for treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.

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Published Studies Related to Jakafi (Ruxolitinib)

A randomized dose-escalation study to assess the safety, tolerability, and pharmacokinetics of ruxolitinib (INC424) in healthy Japanese volunteers. [2013]
Ruxolitinib (INC424), a potent and selective oral Janus kinase 1 and 2 inhibitor, was recently approved by the US food and drug administration for the treatment of intermediate or high-risk myelofibrosis... There were no apparent differences in the safety or PK of ruxolitinib between Japanese and non-Japanese subjects.

A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. [2012]
clinically significant activity in myelofibrosis... CONCLUSIONS: Ruxolitinib, as compared with placebo, provided significant clinical

Impact of ruxolitinib on the natural history of primary myelofibrosis: a comparison of the DIPSS and the COMFORT-2 cohorts. [2014]
The international prognostic scoring system (IPSS) provides reliable risk assessment in patients with primary myelofibrosis (PMF). Recent clinical trials in PMF patients with intermediate-2 or high IPSS risk have shown a survival advantage of ruxolitinib over placebo (COMFORT-1) or best available therapy (COMFORT-2)...

Resolution of bone marrow fibrosis in a patient receiving JAK1/JAK2 inhibitor treatment with ruxolitinib. [2013]
Ruxolitinib, a JAK1/JAK2 inhibitor, is currently the only pharmacological agent approved for the treatment of myelofibrosis. Approval was based on findings from two phase 3 trials comparing ruxolitinib with placebo (COMFORT-I) and with best available therapy (COMFORT-II) for the treatment of primary or secondary myelofibrosis...

Efficacy, safety and survival with ruxolitinib in patients with myelofibrosis: results of a median 2-year follow-up of COMFORT-I. [2013]
COMFORT-I is a randomized, double-blind, placebo-controlled trial of the Janus kinase 1/Janus kinase 2 inhibitor ruxolitinib in 309 patients with intermediate-2 or high-risk myelofibrosis. This analysis of COMFORT-I describes the long-term efficacy and safety of ruxolitinib (median follow-up, 2 years)...

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Clinical Trials Related to Jakafi (Ruxolitinib)

Ruxolitinib for Chronic Myeloid Leukemia (CML) With Minimal Residual Disease (MRD) [Recruiting]
This is a 2 part study. The goal of the first part of this clinical research study is to find the highest tolerable dose of ruxolitinib that can be given with a TKI that you are already taking (such as gleevec, sprycel, or nilotinib) as part of your standard of care treatment. The goal of the second part of this study is to learn if this drug combination can help to control CML. Although you have a good response to therapy, the disease is still detectable at low levels (this is called "minimal residual disease"). Researchers believe that eliminating all detectable evidence of disease may decrease the chances that the leukemia will ever come back. The safety of the drug combination will also be studied in both parts. Ruxolitinib is designed to block a protein called Jak2 that may help keep some leukemia cells alive even with TKI therapy. Blocking this protein may cause the cells to die.

Study of Ruxolitinib Plus Decitabine in Patients With Acute Myeloid Leukemia (AML) [Recruiting]
This clinical research study is made up of 2 parts: Phase 1 and Phase 2. The goal of Phase 1 of this study is to find the highest tolerable dose of the combination of decitabine and ruxolitinib that can be given to patients with AML. The goal of Phase 2 of this study is to learn if decitabine and ruxolitinib can help to control a certain kind of AML called post myeloproliferative neoplasm AML (post MPN-AML). The safety of the drug combination will be studied in both phases.

Ruxolitinib and Pracinostat Combination Therapy for Patients With Myelofibrosis (MF) [Recruiting]
The goal of this clinical research study is to learn if pracinostat, when given in combination with ruxolitinib, can help to control MF. The safety of this drug combination will also be studied.

Administration of Jakafi (Ruxolitinib) for Symptom Control of Patients With Chronic Lymphocytic Leukemia (CLL): Phase II [Recruiting]
The goal of this clinical research study is to learn if Jakafi (ruxolitinib) can help to control fatigue and other symptoms in patients with CLL who do not need treatment for the cancer. Researchers also want to learn if ruxolitinib can decrease the size of enlarged lymph nodes and/or lower the number of CLL cells in the blood.

Ruxolitinib or Dasatinib With Chemotherapy in Patients With Philadelphia Chromosome (Ph)-Like Acute Lymphoblastic Leukemia (ALL) [Recruiting]
The goal of this clinical research study is to learn if ruxolitinib or dasatinib in combination with chemotherapy can help to control Ph-like ALL. The safety of these drug combinations will also be studied.

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Page last updated: 2015-08-10

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