Ibrutinib
- Generic Name
- Ibrutinib
- Brand Names
- Imbruvica
- Drug Type
- Small Molecule
- Chemical Formula
- C25H24N6O2
- 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
- -
A Study to Determine the Absorption, Metabolism, and Routes of Excretion of (14C) Radiolabeled Ibrutinib in Healthy Male Participants
- First Posted Date
- 2012-08-28
- Last Posted Date
- 2014-11-05
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 6
- Registration Number
- NCT01674322
Study of Ibrutinib (a Bruton's Tyrosine Kinase Inhibitor), Versus Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy
- First Posted Date
- 2012-07-20
- Last Posted Date
- 2018-01-19
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 280
- Registration Number
- NCT01646021
A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Participants
- First Posted Date
- 2012-06-25
- Last Posted Date
- 2013-06-19
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 21
- Registration Number
- NCT01626651
A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- Conditions
- Interventions
- First Posted Date
- 2012-06-04
- Last Posted Date
- 2020-03-03
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 578
- Registration Number
- NCT01611090
A Study to Evaluate the Efficacy and Safety of Ibrutinib, in Patients With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy
- First Posted Date
- 2012-05-16
- Last Posted Date
- 2016-06-01
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 120
- Registration Number
- NCT01599949
PCI-32765 (Ibrutinib) in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or B-cell Prolymphocytic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2012-05-01
- Last Posted Date
- 2024-02-13
- Lead Sponsor
- Kami Maddocks, MD
- Target Recruit Count
- 154
- Registration Number
- NCT01589302
- Locations
- 🇺🇸
Ohio State University Medical Center, Columbus, Ohio, United States
A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia
- Conditions
- Interventions
- First Posted Date
- 2012-04-17
- Last Posted Date
- 2019-12-18
- Lead Sponsor
- Pharmacyclics LLC.
- Target Recruit Count
- 391
- Registration Number
- NCT01578707
- Locations
- 🇺🇸
Site # 059, New Brunswick, New Jersey, United States
🇦🇺Site # 501, Fitzroy, Victoria, Australia
🇺🇸Site #408, La Jolla, California, United States
Safety and Efficacy Study of a BTK Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma
- First Posted Date
- 2011-03-30
- Last Posted Date
- 2017-03-31
- Lead Sponsor
- Pharmacyclics LLC.
- Target Recruit Count
- 78
- Registration Number
- NCT01325701
- Locations
- 🇺🇸
UCLA Medical Center, Los Angeles, California, United States
🇺🇸The Ohio Sate university, Columbus, Ohio, United States
🇺🇸Univerity of Washington, Seattle, Washington, United States
Drug Development Updates
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