Ibrutinib

Generic Name: Ibrutinib

Brand Names: Imbruvica

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₂₄N_₆O_₂

CAS Number: 936563-96-1

Unique Ingredient Identifier: 1X70OSD4VX

Background: Ibrutinib is a small molecule that acts as an irreversible potent inhibitor of Burton's tyrosine kinase. It is designated as a targeted covalent drug and presented as a promising activity in B-cell malignancies in clinical trials. Ibrutinib was developed by Pharmacyclics Inc and was first approved by the FDA in November 2013 for the treatment of mantle cell ...

Indication: Ibrutinib is indicated for the treatment of the following conditions.

Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)

Waldenström's macroglobulinemia

Chronic graft-versus-host disease (cGVHD)

Mantle cell lymphoma (MCL)

Marginal zone lymphoma (MZL)

Associated Conditions: Chronic Graft-Versus-Host Disease, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma (MZL), Refractory Mantle Cell Lymphoma, Relapsed Mantle Cell Lymphoma, Small Lymphocytic Lymphoma, Steroid-dependent chronic graft-versus-host disease, Waldenström's Macroglobulinemia (WM), Steroid refractory Chronic graft versus host disease

Associated Therapies: -

Clinical Trials

Ibrutinib as an Immune Modulating Agent for Patients With Asymptomatic, High-risk CLL/SLL Risk Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Phase 2

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Biological: Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed
Drug: Ibrutinib
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Biological: Pneumococcal 13-valent Conjugate Vaccine
Other: Quality-of-Life Assessment
Biological: Trivalent Influenza Vaccine

First Posted Date: 2015-08-10

Last Posted Date: 2024-05-17

Lead Sponsor: Jennifer Woyach

Target Recruit Count: 42

Registration Number: NCT02518555

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

A Phase II Study Using Ibrutinib and Short-Course Fludarabine in Treatment-Naive CLL

Phase 2

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Ibrutinib
Drug: Fludarabine

First Posted Date: 2015-08-03

Last Posted Date: 2023-03-24

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 29

Registration Number: NCT02514083

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)

Phase 3

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Acalabrutinib
Drug: Ibrutinib

First Posted Date: 2015-06-23

Last Posted Date: 2024-11-01

Lead Sponsor: Acerta Pharma BV

Target Recruit Count: 533

Registration Number: NCT02477696

Locations: 🇬🇧
Research Site, Surrey, United Kingdom

ABT-199 & Ibrutinib in Mantle Cell Lymphoma (AIM)

Phase 2

Active, not recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: ABT-199
Drug: Ibrutinib

First Posted Date: 2015-06-15

Last Posted Date: 2023-08-21

Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Target Recruit Count: 37

Registration Number: NCT02471391

Locations: 🇦🇺
Peter MacCallum Cancer Centre, East Melbourne, Victoria, Australia
🇦🇺
Royal Melbourne Hospital, Melbourne, Victoria, Australia

A Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma

Phase 2

Completed

Conditions: Relapsed/Refractory Mantle Cell Lymphoma

Interventions: Drug: Lenalidomide
Drug: Ibrutinib
Drug: Rituximab

First Posted Date: 2015-06-02

Last Posted Date: 2020-04-24

Lead Sponsor: Lund University Hospital

Target Recruit Count: 50

Registration Number: NCT02460276

Locations: 🇸🇪
Lund University Hospital, Lund, Sweden
🇸🇪
Uppsala Akademiska Hospital, Uppsala, Sweden
🇩🇰
Rigshospitalet, Copenhagen, Denmark

and more 2 locations

Rituximab With or Without Ibrutinib for Patients With Advanced Follicular Lymphoma

Phase 2

Terminated

Conditions: Follicular Lymphoma

Interventions: Drug: Ibrutinib
Drug: Rituximab

First Posted Date: 2015-05-21

Last Posted Date: 2024-03-13

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 190

Registration Number: NCT02451111

Locations: 🇦🇹
Akademisches Lehrkrankenhaus Feldkirch, Feldkirch, Austria
🇩🇰
Aalborg Universitetshospital, Aalborg, Denmark
🇫🇮
Helsinki University Hospital, Helsinki, Finland

and more 38 locations

Dose Finding Study of Ibrutinib Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma

Phase 1

Active, not recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Lenalidomide
Drug: Ibrutinib
Drug: Rituximab

First Posted Date: 2015-05-18

Last Posted Date: 2024-02-22

Lead Sponsor: Hackensack Meridian Health

Target Recruit Count: 27

Registration Number: NCT02446236

Locations: 🇺🇸
The Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States

Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Phase 3

Active, not recruiting

Conditions: Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type
Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type

Interventions: Procedure: Autologous Bone Marrow Transplantation
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Drug: Carmustine
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Etoposide
Drug: Ibrutinib
Other: Laboratory Biomarker Analysis
Drug: Melphalan
Other: Placebo Administration
Other: Pharmacogenomic Study

First Posted Date: 2015-05-13

Last Posted Date: 2024-11-14

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 302

Registration Number: NCT02443077

Locations: 🇺🇸
Logan Health Medical Center, Kalispell, Montana, United States
🇺🇸
Marshfield Medical Center - Minocqua, Minocqua, Wisconsin, United States
🇺🇸
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States

and more 279 locations

Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma

Phase 2

Recruiting

Conditions: Lymphoma

Interventions: Drug: Ibrutinib
Drug: Rituximab
Drug: Gemcitabine
Drug: Dexamethasone
Drug: Mesna
Drug: Cisplatin
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Selinexor
Drug: G-CSF

First Posted Date: 2015-05-07

Last Posted Date: 2024-06-12

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 320

Registration Number: NCT02436707

Locations: 🇨🇦
BCCA - Vancouver, Vancouver, British Columbia, Canada
🇨🇦
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
🇨🇦
Cross Cancer Institute, Edmonton, Alberta, Canada

and more 11 locations

Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma (RESOLVE)

Phase 3

Completed

Conditions: Metastatic Pancreatic Adenocarcinoma

Interventions: Drug: Gemcitabine
Drug: Ibrutinib
Drug: Nab-paclitaxel

First Posted Date: 2015-05-07

Last Posted Date: 2020-12-30

Lead Sponsor: Pharmacyclics LLC.

Target Recruit Count: 430

Registration Number: NCT02436668

Locations: 🇺🇸
Oncology Specialties, PC; Clearview Cancer Institute, Huntsville, Alabama, United States
🇺🇸
Moores UCSD Cancer Center, La Jolla, California, United States
🇺🇸
St. Mary's Medical Center, Daly City, California, United States

and more 83 locations

Drug Development Updates

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