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Last Updated: May 11, 2021

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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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ibrutinib

Condition Name

Condition Name for Ibrutinib
Intervention Trials
Chronic Lymphocytic Leukemia 61
Mantle Cell Lymphoma 32
Small Lymphocytic Lymphoma 25
Lymphoma 16
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Condition MeSH

Condition MeSH for Ibrutinib
Intervention Trials
Lymphoma 158
Leukemia, Lymphoid 121
Leukemia, Lymphocytic, Chronic, B-Cell 120
Leukemia 111
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Clinical Trial Locations for Ibrutinib

Trials by Country

Trials by Country for Ibrutinib
Location Trials
United States 897
France 53
Canada 49
Spain 45
United Kingdom 42
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Trials by US State

Trials by US State for Ibrutinib
Location Trials
California 74
Texas 66
New York 59
Ohio 53
New Jersey 41
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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 36
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Ibrutinib
Clinical Trial Phase Trials
Recruiting 150
Not yet recruiting 102
Active, not recruiting 39
[disabled in preview] 15
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Clinical Trial Sponsors for Ibrutinib

Sponsor Name

Sponsor Name for Ibrutinib
Sponsor Trials
Pharmacyclics LLC. 74
National Cancer Institute (NCI) 63
Janssen Research & Development, LLC 38
[disabled in preview] 26
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Sponsor Type

Sponsor Type for Ibrutinib
Sponsor Trials
Industry 251
Other 218
NIH 67
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