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Last Updated: January 21, 2020

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CLINICAL TRIALS PROFILE FOR IBRUTINIB

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505(b)(2) Clinical Trials for Ibrutinib

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT02436707 Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma Recruiting Janssen, LP Phase 2 2015-06-01 The purpose of this study is to find out what effects new combinations of treatment will have this disease. In this clinical trial, the study treatment options currently are ibrutinib plus R-GDP, or R-GDP alone.
New Combination NCT02436707 Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma Recruiting Canadian Cancer Trials Group Phase 2 2015-06-01 The purpose of this study is to find out what effects new combinations of treatment will have this disease. In this clinical trial, the study treatment options currently are ibrutinib plus R-GDP, or R-GDP alone.
New Formulation NCT02841150 Study to Assess the Bioequivalence of Ibrutinib 560- Milligram (mg) Tablet to Four 140 -mg IMBRUVICA Capsules Completed Janssen Research & Development, LLC Phase 1 2016-06-01 The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.
New Formulation NCT02877225 Study to Assess the Bioequivalence of Ibrutinib 140 Milligram (mg) Tablet to 140 mg IMBRUVICA Capsule Recruiting Janssen Research & Development, LLC Phase 1 2016-08-01 The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Ibrutinib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01217749 Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL Completed Ohio State University Phase 1/Phase 2 2010-12-01 The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily regimen of orally administered PCI-32765 combined with ofatumumab in subjects with relapsed/refractory CLL/SLL and related diseases
NCT01217749 Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL Completed Pharmacyclics LLC. Phase 1/Phase 2 2010-12-01 The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily regimen of orally administered PCI-32765 combined with ofatumumab in subjects with relapsed/refractory CLL/SLL and related diseases
NCT01236391 Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL) Completed Janssen Pharmaceuticals Phase 2 2011-02-01 The primary objective of this study was to evaluate the efficacy of ibrutinib in participants with relapsed or refractory MCL. The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg daily) of PCI-32765 in this population.
NCT01236391 Safety and Efficacy of PCI-32765 in Participants With Relapsed/Refractory Mantle Cell Lymphoma (MCL) Completed Pharmacyclics LLC. Phase 2 2011-02-01 The primary objective of this study was to evaluate the efficacy of ibrutinib in participants with relapsed or refractory MCL. The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg daily) of PCI-32765 in this population.
NCT01500733 PCI-32765 for Special Cases of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Active, not recruiting National Heart, Lung, and Blood Institute (NHLBI) Phase 2 2011-11-01 Background: - Chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL) are types of blood or lymph node cancers that mostly affect the elderly. CLL/SLL both create abnormal white blood cells that hurt the immune system and make it more difficult to fight infections. These cancers are usually diagnosed after age 50; more than half of the people with CLL/SLL are over age 70. Elderly people often do not respond well to standard chemotherapy for CLL/SLL. They may have other health problems that make chemotherapy difficult. In addition, individuals who have a genetic abnormality called 17p deletion also do not respond well to standard treatments for CLL/SLL. Researchers want to test a new cancer treatment drug, PCI-32765, to see if it can treat CLL/SLL in these hard-to-treat groups. Objectives: - To see if PCI-32765 is a safe and effective treatment for CLL/SLL in older people and people with 17p deletion. Eligibility: - Individuals over 65 years of age who have CLL/SLL. - Individuals at least 18 years of age who have CLL/SLL and 17p deletion. Design: - Participants will be screened with a medical history, physical exam, and imaging studies. Blood and urine samples will be taken. Optional bone marrow and lymph node biopsies may also be taken. - Participants will take PCI-32765 capsules every day for 28 days (one cycle of treatment). Treatment will be monitored with frequent blood tests and clinic visits. - PCI-32765 will be given for six cycles of treatment. Those who benefit from the drug will continue to take it as long as there are no side effects and the disease does not progress. Those who do not benefit will stop treatment and have regular followup exams.
NCT01520519 Phase 2 Study of the Combination of Bruton's Tyrosine Kinase Inhibitor PCI-32765 and Rituximab in High-Risk Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Patients Active, not recruiting Pharmacyclics LLC. Phase 2 2012-02-01 The goal of this clinical research study is to learn if PCI-32765 (Ibrutinib) combined with rituximab can help to control CLL and SLL. The safety of this combination will also be studied. Ibrutinib is designed to stop a protein from working in the cells, which may cause the cancer cells to die or stop growing. Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to die.
NCT01520519 Phase 2 Study of the Combination of Bruton's Tyrosine Kinase Inhibitor PCI-32765 and Rituximab in High-Risk Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Patients Active, not recruiting M.D. Anderson Cancer Center Phase 2 2012-02-01 The goal of this clinical research study is to learn if PCI-32765 (Ibrutinib) combined with rituximab can help to control CLL and SLL. The safety of this combination will also be studied. Ibrutinib is designed to stop a protein from working in the cells, which may cause the cancer cells to die or stop growing. Rituximab is designed to attach to cancer cells and damage them, which may cause the cells to die.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ibrutinib

Condition Name

Condition Name for Ibrutinib
Intervention Trials
Chronic Lymphocytic Leukemia 53
Mantle Cell Lymphoma 28
Small Lymphocytic Lymphoma 21
Lymphoma 14
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Condition MeSH

Condition MeSH for Ibrutinib
Intervention Trials
Lymphoma 141
Leukemia, Lymphoid 107
Leukemia, Lymphocytic, Chronic, B-Cell 105
Leukemia 100
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Clinical Trial Locations for Ibrutinib

Trials by Country

Trials by Country for Ibrutinib
Location Trials
United States 868
France 51
Canada 49
Spain 45
United Kingdom 42
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Trials by US State

Trials by US State for Ibrutinib
Location Trials
California 72
Texas 63
New York 57
Ohio 52
New Jersey 39
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Clinical Trial Progress for Ibrutinib

Clinical Trial Phase

Clinical Trial Phase for Ibrutinib
Clinical Trial Phase Trials
Phase 4 4
Phase 3 33
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Ibrutinib
Clinical Trial Phase Trials
Recruiting 144
Not yet recruiting 72
Active, not recruiting 38
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Clinical Trial Sponsors for Ibrutinib

Sponsor Name

Sponsor Name for Ibrutinib
Sponsor Trials
Pharmacyclics LLC. 70
National Cancer Institute (NCI) 56
Janssen Research & Development, LLC 37
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Sponsor Type

Sponsor Type for Ibrutinib
Sponsor Trials
Industry 228
Other 184
NIH 59
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