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Last Updated: January 21, 2020

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CLINICAL TRIALS PROFILE FOR IMBRUVICA

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505(b)(2) Clinical Trials for Imbruvica

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 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 Imbruvica

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01779791 A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma Completed Pharmacyclics LLC. Phase 2 2013-04-01 The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).
NCT01779791 A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma Completed Janssen Research & Development, LLC Phase 2 2013-04-01 The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).
NCT01829568 Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular Lymphoma Active, not recruiting Celgene Corporation Phase 1 2013-06-01 This phase I clinical trial studies the side effects and best dose of lenalidomide and ibrutinib when given together with rituximab in treating patients with previously untreated stage II-IV follicular lymphoma. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can find cancer cells and help kill them. Giving lenalidomide and ibrutinib together with rituximab may work well in treating follicular lymphoma.
NCT01829568 Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular Lymphoma Active, not recruiting National Cancer Institute (NCI) Phase 1 2013-06-01 This phase I clinical trial studies the side effects and best dose of lenalidomide and ibrutinib when given together with rituximab in treating patients with previously untreated stage II-IV follicular lymphoma. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can find cancer cells and help kill them. Giving lenalidomide and ibrutinib together with rituximab may work well in treating follicular lymphoma.
NCT01841723 Ibrutinib in Treating Patients With Relapsed Hairy Cell Leukemia Recruiting National Cancer Institute (NCI) Phase 2 2013-04-01 This phase II trial studies how well ibrutinib works in treating patients with hairy cell leukemia that has returned after a period of improvement. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
NCT01849263 Ibrutinib in Treating Patients With Relapsed or Refractory Follicular Lymphoma Active, not recruiting National Cancer Institute (NCI) Phase 2 2013-04-01 This phase II trial studies how well ibrutinib works in treating patients with follicular lymphoma that has come back after a period of improvement or does not respond to treatment. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Imbruvica

Condition Name

Condition Name for Imbruvica
Intervention Trials
Chronic Lymphocytic Leukemia 26
Mantle Cell Lymphoma 11
Small Lymphocytic Lymphoma 9
Recurrent Mantle Cell Lymphoma 7
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Condition MeSH

Condition MeSH for Imbruvica
Intervention Trials
Lymphoma 52
Leukemia, Lymphoid 44
Leukemia, Lymphocytic, Chronic, B-Cell 43
Leukemia 41
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Clinical Trial Locations for Imbruvica

Trials by Country

Trials by Country for Imbruvica
Location Trials
United States 311
Spain 18
Canada 10
Australia 7
Germany 7
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Trials by US State

Trials by US State for Imbruvica
Location Trials
Texas 28
Ohio 22
California 20
New York 15
Massachusetts 14
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Clinical Trial Progress for Imbruvica

Clinical Trial Phase

Clinical Trial Phase for Imbruvica
Clinical Trial Phase Trials
Phase 4 1
Phase 3 13
Phase 2 54
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Clinical Trial Status

Clinical Trial Status for Imbruvica
Clinical Trial Phase Trials
Recruiting 70
Not yet recruiting 35
Active, not recruiting 9
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Clinical Trial Sponsors for Imbruvica

Sponsor Name

Sponsor Name for Imbruvica
Sponsor Trials
National Cancer Institute (NCI) 39
Pharmacyclics LLC. 20
M.D. Anderson Cancer Center 18
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Sponsor Type

Sponsor Type for Imbruvica
Sponsor Trials
Other 90
Industry 82
NIH 39
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