Ruxolitinib

Generic Name: Ruxolitinib

Brand Names: Jakafi, Jakavi, Opzelura

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₈N_₆

CAS Number: 941678-49-5

Unique Ingredient Identifier: 82S8X8XX8H

Background: Ruxolitinib, formerly known as INCB018424 or INC424, is an anticancer drug and a Janus kinase (JAK) inhibitor. It is a potent and selective inhibitor of JAK1 and JAK2, which are tyrosine kinases involved in cytokine signalling and hematopoiesis. Myeloproliferative neoplasms, such as myelofibrosis and polycythemia vera, are often characterized by aberrant act...

Indication: Ruxolitinib is indicated for the treatment of the following conditions:

Topical ruxolitinib is indicated for:

Associated Conditions: Acute Graft-Versus-Host Disease (GVHD), Chronic Graft-Versus-Host Disease, Non-segmental Vitiligo, Post Polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis (Post-ET MF), Primary Myelofibrosis (PMF), High risk Myelofibrosis, Intermediate risk Myelofibrosis, Mild Atopic dermatitis, Moderate Atopic dermatitis, Refractory Polycythemia vera

Associated Therapies: -

Clinical Trials

CINC424A2X01B Rollover Protocol

Phase 4

Active, not recruiting

Conditions: Primary Myelofibrosis
Polycythemia Vera
Thalassemia
Acute Myeloid Leukemia
Graft Versus Host Disease

Interventions: Drug: ruxolitinib
Drug: panobinostat

First Posted Date: 2015-03-12

Last Posted Date: 2024-11-27

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 356

Registration Number: NCT02386800

Locations: 🇹🇷
Novartis Investigative Site, Talas Kayseri, Turkey

Study of the Safety of PIM447 in Combination With Ruxolitinib (INC424) and LEE011 in Patients With Myelofibrosis

Phase 1

Completed

Conditions: Myelofibrosis

Interventions: Drug: PIM447
Drug: Ruxolitinib
Drug: LEE011

First Posted Date: 2015-02-25

Last Posted Date: 2022-02-09

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 15

Registration Number: NCT02370706

Locations: 🇬🇧
Novartis Investigative Site, London, United Kingdom

Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available.

Phase 3

Completed

Conditions: Polycythemia Vera

Interventions: Drug: Ruxolitinib

First Posted Date: 2014-11-17

Last Posted Date: 2019-07-18

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 161

Registration Number: NCT02292446

Locations: 🇹🇭
Novartis Investigative Site, Chiang Mai, Thailand

Ruxolitinib and Pracinostat Combination Therapy for Patients With Myelofibrosis (MF)

Phase 2

Completed

Conditions: Myeloproliferative Diseases

Interventions: Drug: Ruxolitinib
Drug: Pracinostat
Behavioral: Questionnaire

First Posted Date: 2014-10-17

Last Posted Date: 2019-06-12

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 25

Registration Number: NCT02267278

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Safety and Tolerability of Combined Treatment With Nilotinib and Ruxolitinib in CML and Ph+ ALL Patients

Phase 1

Completed

Conditions: Chronic Myeloid Leukemia

Interventions: Drug: Nilotinib
Drug: Ruxolitinib

First Posted Date: 2014-10-01

Last Posted Date: 2019-05-01

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 5

Registration Number: NCT02253277

Locations: 🇩🇪
Novartis Investigative Site, Leipzig, Germany

JAK Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis

Phase 2

Active, not recruiting

Conditions: Secondary Myelofibrosis
Primary Myelofibrosis

Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Drug: Busulfan
Drug: Cyclophosphamide
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Melphalan
Drug: Methotrexate
Drug: Mycophenolate Mofetil
Drug: Ruxolitinib
Drug: Tacrolimus
Radiation: Total-Body Irradiation
Procedure: Umbilical Cord Blood Transplantation

First Posted Date: 2014-09-29

Last Posted Date: 2024-03-05

Lead Sponsor: Fred Hutchinson Cancer Center

Target Recruit Count: 61

Registration Number: NCT02251821

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

JAK-inhibition in Recurrent Classical Hodgkin Lymphoma

Phase 2

Completed

Conditions: Recurrent Classical Hodgkin Lymphoma

Interventions: Drug: Ruxolitinib

First Posted Date: 2014-06-16

Last Posted Date: 2020-04-06

Lead Sponsor: University of Cologne

Target Recruit Count: 12

Registration Number: NCT02164500

Locations: 🇩🇪
1st Dept. of Medicine, Cologne University Hospital, Cologne, Germany

A Phase 2 Study of CPI-0610 With and Without Ruxolitinib in Patients With Myelofibrosis

Phase 1

Active, not recruiting

Conditions: Myelofibrosis
Leukemia, Myelocytic, Acute
Myelodysplastic/Myeloproliferative Neoplasm
Precancerous Conditions
Neoplasms
Leukemia
Primary Myelofibrosis
Bone Marrow Disease
Hematological Disease
Myeloproliferative Disorders

Interventions: Drug: Pelabresib (CPI-0610)
Drug: Ruxolitinib

First Posted Date: 2014-06-09

Last Posted Date: 2024-11-04

Lead Sponsor: Constellation Pharmaceuticals

Target Recruit Count: 336

Registration Number: NCT02158858

Locations: 🇺🇸
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇧🇪
UZ Leuven - Campus Gasthuisberg, Leuven, Viaams Braban, Belgium
🇺🇸
ICAHN School of Medicine at Mount Sinai, New York, New York, United States

and more 45 locations

Trial of Ruxolitinib and Erlotinib in Patients With EGFR-mutant Lung Adenocarcinoma With Acquired Resistance to Erlotinib

Phase 1

Completed

Conditions: Lung Cancer

Interventions: Drug: Ruxolitinib
Drug: Erlotinib

First Posted Date: 2014-06-04

Last Posted Date: 2019-01-16

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 22

Registration Number: NCT02155465

Locations: 🇺🇸
Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States
🇺🇸
Memoral Sloan Kettering Cancer Center at Phelps, Sleepy Hollow, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States

and more 3 locations

Flotetuzumab in Primary Induction Failure (PIF) or Early Relapse (ER) Acute Myeloid Leukemia (AML)

Phase 1

Terminated

Conditions: AML

Interventions: Biological: Flotetuzumab 3 ng/kg/day, 4 days on and 3 days off
Biological: Flotetuzumab 10 ng/kg/day, 4 days on and 3 days off
Biological: Flotetuzumab 30 ng/kg/day, 4 days on and 3 days off
Biological: Flotetuzumab 100 ng/kg/day, 4 days on and 3 days off
Biological: Flotetuzumab 300 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose
Biological: Flotetuzumab 500 ng/kg/day, 4 days on 3 days off, after one-step lead-in dose
Biological: Flotetuzumab 500 ng/kg/day, continuous infusion, after multi-step lead-in dose
Biological: Flotetuzumab 700 ng/kg/day, 4 days on 3 days off, after multi-step lead-in dose
Biological: Flotetuzumab 300 ng/kg/day, continuous infusion, after multi-step lead-in dose
Biological: Flotetuzumab 700 ng/kg/day, continuous infusion, after multi-step lead-in dose
Drug: Ruxolitinib

First Posted Date: 2014-06-02

Last Posted Date: 2024-01-30

Lead Sponsor: MacroGenics

Target Recruit Count: 244

Registration Number: NCT02152956

Locations: 🇺🇸
University of Maryland, Baltimore, Maryland, United States
🇺🇸
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇮🇱
Shaare Zedek Medical Center, Jerusalem, Israel

and more 40 locations

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