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Last Updated: December 12, 2024

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 2015-05-05 The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.
New Combination NCT02436707 ↗ Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma Recruiting Karyopharm Therapeutics Inc Phase 2 2015-05-05 The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.
New Combination NCT02436707 ↗ Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma Recruiting Roche Pharma AG Phase 2 2015-05-05 The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.
New Combination NCT02436707 ↗ Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma Recruiting Canadian Cancer Trials Group Phase 2 2015-05-05 The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.
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.
>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.
NCT01325701 ↗ Safety and Efficacy Study of a BTK Inhibitor in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma Completed Pharmacyclics LLC. Phase 2 2011-05-01 The purpose of this study is to evaluate the efficacy of ibrutinib (PCI-32765) in relapsed/refractory de novo activated B-cell (ABC) and germinal-cell B-Cell (GCB) Diffuse Large B-cell Lymphoma (DLBCL).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ibrutinib

Condition Name

Condition Name for Ibrutinib
Intervention Trials
Chronic Lymphocytic Leukemia 70
Mantle Cell Lymphoma 39
Small Lymphocytic Lymphoma 33
Waldenstrom Macroglobulinemia 20
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Condition MeSH

Condition MeSH for Ibrutinib
Intervention Trials
Lymphoma 187
Leukemia, Lymphoid 131
Leukemia, Lymphocytic, Chronic, B-Cell 131
Leukemia 121
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Clinical Trial Locations for Ibrutinib

Trials by Country

Trials by Country for Ibrutinib
Location Trials
France 90
Spain 90
United Kingdom 87
Italy 87
Australia 80
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Trials by US State

Trials by US State for Ibrutinib
Location Trials
California 99
New York 93
Texas 91
Ohio 80
New Jersey 65
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Clinical Trial Progress for Ibrutinib

Clinical Trial Phase

Clinical Trial Phase for Ibrutinib
Clinical Trial Phase Trials
Phase 4 3
Phase 3 44
Phase 2/Phase 3 3
[disabled in preview] 226
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Clinical Trial Status

Clinical Trial Status for Ibrutinib
Clinical Trial Phase Trials
Active, not recruiting 101
Recruiting 100
Completed 75
[disabled in preview] 52
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Clinical Trial Sponsors for Ibrutinib

Sponsor Name

Sponsor Name for Ibrutinib
Sponsor Trials
Pharmacyclics LLC. 85
National Cancer Institute (NCI) 75
Janssen Research & Development, LLC 43
[disabled in preview] 41
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Sponsor Type

Sponsor Type for Ibrutinib
Sponsor Trials
Industry 315
Other 294
NIH 81
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