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

Clinical-biological Characteristics and Outcome of Chronic Lymphocytic Leukemia Under Ibrutinib-named Patient Program

Completed

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Ibrutinib

First Posted Date: 2015-10-21

Last Posted Date: 2021-09-13

Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Target Recruit Count: 264

Registration Number: NCT02582320

Locations: 🇮🇹
U.O.C. Ematologia - IRCCS Centro oncologico della Basilicata, Rionero in Vulture, Italy
🇮🇹
Policlinico Umberto I, Hematology Department - Sapienza, Rome, Italy
🇮🇹
Sezione di Ematologia Cancer Center Humanitas, Rozzano, Italy

and more 44 locations

Ibrutinib in Treating Patients With Refractory Metastatic Cutaneous Melanoma

Phase 2

Active, not recruiting

Conditions: Metastatic Melanoma
Stage IV Cutaneous Melanoma AJCC v6 and v7
Recurrent Cutaneous Melanoma

Interventions: Drug: Ibrutinib
Other: Laboratory Biomarker Analysis
Other: Pharmacogenomic Study
Other: Pharmacological Study

First Posted Date: 2015-10-21

Last Posted Date: 2024-07-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 18

Registration Number: NCT02581930

Locations: 🇺🇸
Case Western Reserve University, Cleveland, Ohio, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States

and more 10 locations

Phase II Study of Ibrutinib in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors

Phase 2

Completed

Conditions: Carcinoid Tumors
Pancreatic NET

Interventions: Drug: Ibrutinib

First Posted Date: 2015-10-14

Last Posted Date: 2020-09-11

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 20

Registration Number: NCT02575300

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

Ibrutinib Combined With Gemcitabine and Nab-Paclitaxel in Patients With Metastatic Pancreatic Cancer

Phase 1

Completed

Conditions: Metastatic Pancreatic Adenocarcinoma

Interventions: Drug: Ibrutinib
Drug: Paclitaxel
Drug: Gemcitabine

First Posted Date: 2015-09-29

Last Posted Date: 2021-05-06

Lead Sponsor: Margaret Tempero

Target Recruit Count: 18

Registration Number: NCT02562898

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
Oregon Health and Science University, Portland, Oregon, United States

A Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Treatment-naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Phase 1

Completed

Conditions: Lymphocytic Leukemia

Interventions: Drug: Ibrutinib

First Posted Date: 2015-09-22

Last Posted Date: 2019-08-14

Lead Sponsor: Janssen Pharmaceutical K.K.

Target Recruit Count: 8

Registration Number: NCT02556892

Ibrutinib and Azacitidine for Treatment of Higher Risk Myelodysplastic Syndrome

Phase 1

Completed

Conditions: Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndrome
Previously Treated Myelodysplastic Syndrome
Refractory Anemia With Excess Blasts in Transformation
Secondary Myelodysplastic Syndrome

Interventions: Drug: Azacitidine
Drug: Ibrutinib

First Posted Date: 2015-09-18

Last Posted Date: 2022-10-06

Lead Sponsor: Brian Jonas

Target Recruit Count: 21

Registration Number: NCT02553941

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States
🇺🇸
UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

and more 2 locations

Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma

Phase 1

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Ibrutinib
Drug: Pomalidomide
Drug: Placebo
Drug: Dexamethasone

First Posted Date: 2015-09-14

Last Posted Date: 2019-11-21

Lead Sponsor: Pharmacyclics LLC.

Target Recruit Count: 11

Registration Number: NCT02548962

Locations: 🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
Cleveland Clinic, Cleveland, Ohio, United States
🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States

and more 13 locations

Study of Ibrutinib in Patients With Relapsed or Refractory Primary Central Nervous Lymphoma or Intraocular Lymphoma

Phase 2

Completed

Conditions: Primary Central Nervous Lymphoma
Intraocular Lymphoma

Interventions: Drug: Ibrutinib

First Posted Date: 2015-09-07

Last Posted Date: 2022-04-14

Lead Sponsor: The Lymphoma Academic Research Organisation

Target Recruit Count: 52

Registration Number: NCT02542514

Locations: 🇫🇷
CHU d'ESTAING, Clermont Ferrand, France
🇫🇷
CHRU de LILLE - Claude Huriez, Lille, France
🇫🇷
Centre Léon Bérard, Lyon, France

and more 7 locations

A Study of Ibrutinib + Obinutuzumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Phase 1

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Obinutuzumab
Drug: Ibrutinib

First Posted Date: 2015-09-01

Last Posted Date: 2024-07-30

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 54

Registration Number: NCT02537613

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

and more 1 locations

Ibrutinib in Combination With Rituximab and Lenalidomide in Treating Patients With Previously Untreated, Stage II-IV Follicular Lymphoma or Marginal Zone Lymphoma

Phase 2

Completed

Conditions: Ann Arbor Stage II Follicular Lymphoma
Ann Arbor Stage II Marginal Zone Lymphoma
Ann Arbor Stage III Follicular Lymphoma
Ann Arbor Stage III Marginal Zone Lymphoma
Ann Arbor Stage IV Follicular Lymphoma
Ann Arbor Stage IV Marginal Zone Lymphoma
CD20 Positive
Grade 1 Follicular Lymphoma
Grade 2 Follicular Lymphoma
Grade 3a Follicular Lymphoma

Interventions: Drug: Ibrutinib
Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
Biological: Rituximab

First Posted Date: 2015-08-25

Last Posted Date: 2023-09-25

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 46

Registration Number: NCT02532257

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Drug Development Updates

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