Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial

2014-07-23 21:14:00 | BioPortfolio


Male or female individuals, aged 18 years or older who have been diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) who are either resistant or refractory to, intolerant of, or in the investigator's opinion not candidates for available therapy and for whom treatment of MF is indicated may enroll. This is an open label, randomized study comparing the efficacy and safety of INCB018424 tablets versus best-available therapy, as selected by the investigator. The purpose is to compare the efficacy, safety and tolerability of INCB018424 given twice daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis (PET-MF).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment




Best-available oral and/or parenteral therapies, INCB018424


Novartis Investigative Site


Active, not recruiting



Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:14:00-0400

Clinical Trials [732 Associated Clinical Trials listed on BioPortfolio]

A Study to Evaluate the Safety and Efficacy of INCB018424 Phosphate Cream Applied Topically to Adults With Atopic Dermatitis

The purpose of this study is to establish the efficacy of each strength of INCB018424 cream once daily (QD) or twice daily (BID) in subjects with atopic dermatitis as compared with vehicle...

Study to Determine the Safety and Efficacy of INCB018424 in Patients With Polycythemia Vera or Essential Thrombocythemia

To evaluate the safety and efficacy profile of different treatment regimens of INCB018424 administered to two groups of patients; those with polycythemia vera (PV) and those with essential...

LBH589 (Panobinostat) for the Treatment of Myelofibrosis

LBH589 is an oral drug that targets the myelofibrosis cells in the bone marrow and induces cell death by allowing for the expression of certain suppressed genes that are important in regul...

A Study With INCB018424 Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)

A phase 2 study to find out if the drug INCB018424 Phosphate Cream is safe and has beneficial effects in people who have alopecia areata (partial or complete hair loss) when applied to the...

Phase III Study Investigating the Efficacy and Safety of Ruxolitinib in Early Myelofibrosis Patients With High Molecular Risk Mutations.

Myelofibrosis patients with high molecular risk mutations have an intrinsically aggressive disease with increased risk of leukemic transformation and reduced overall survival. As there are...

PubMed Articles [7088 Associated PubMed Articles listed on BioPortfolio]

The evolving understanding of prognosis in post-essential thrombocythemia myelofibrosis and post-polycythemia vera myelofibrosis vs primary myelofibrosis.

Myelofibrosis (MF) is the most aggressive of the classic Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs). In some patients with essential thrombocytopenia or polycythemia vera, wh...

Low Body Mass Index and Myeloablative Conditioning Regimen Prolong the Duration of Parenteral Nutrition During Hematopoietic Stem Cell Transplantation.

Patients undergoing hematopoietic stem cell transplantation (HSCT) often receive total parenteral nutrition (TPN) due to poor oral intake. In clinical practice, it is difficult to predict adequate nut...

Long-Term Use of Mixed-Oil Lipid Emulsion in Soybean Oil-Intolerant Home Parenteral Nutrition Patients.

Although home parenteral nutrition (HPN) is lifesaving for patients with chronic intestinal failure (IF), long-term use can be associated with complications such as infections, metabolic abnormalities...

Reduced intensity allogeneic stem cell transplantation for younger patients with myelofibrosis.

Allogeneic stem cell transplantation (alloSCT) is a curative procedure for myelofibrosis. Elderly people are mainly affected, limiting the feasibility of myeloablative regimens. The introduction of re...

Impact of anxio-depressive symptoms and cognitive function on oral anticancer therapies adherence.

Oral anticancer therapies have an important place in the therapeutic arsenal, but factors influencing adherence to oral treatment are poorly documented in oncology. The objective of this study was to ...

Medical and Biotech [MESH] Definitions

Therapies using arts or directed at the senses.


Prenatal interventions to correct fetal anomalies or treat FETAL DISEASES in utero. Fetal therapies include several major areas, such as open surgery; FETOSCOPY; pharmacological therapy; INTRAUTERINE TRANSFUSION; STEM CELL TRANSPLANTATION; and GENE THERAPY.

A branch of dentistry dealing with diseases of the oral and paraoral structures and the oral management of systemic diseases. (Hall, What is Oral Medicine, Anyway? Clinical Update: National Naval Dental Center, March 1991, p7-8)

The practice of personal hygiene of the mouth. It includes the maintenance of oral cleanliness, tissue tone, and general preservation of oral health.

More From BioPortfolio on "Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial"

Quick Search


Relevant Topic

The Top 100 Pharmaceutical Companies
Top 10 biotech and pharmaceutical companies worldwide based on market value in 2015 2015 ranking of the global top 10 biotech and pharmaceutical companies based on revenue (in billion U.S. dollars) Johnson & Johnson, U.S. 74...

Searches Linking to this Trial