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Last Updated: March 28, 2024

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 Completed Janssen Research & Development, LLC Phase 1 2016-08-29 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 2013-04-17 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 2013-04-17 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 2013-06-21 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 2013-06-21 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 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 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 2013-04-02 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.
NCT01880567 ↗ Ibrutinib and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or Older Patients With Newly Diagnosed Mantle Cell Lymphoma Active, not recruiting Janssen Pharmaceuticals Phase 2 2013-07-15 This phase II trial studies how well ibrutinib and rituximab work in treating patients with mantle cell lymphoma that has come back or has not responded to treatment or older patients with newly diagnosed mantle cell lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may find cancer cells and help kill them. Giving ibrutinib and rituximab may be an effective treatment for mantle cell lymphoma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for IMBRUVICA

Condition Name

Condition Name for IMBRUVICA
Intervention Trials
Chronic Lymphocytic Leukemia 30
Mantle Cell Lymphoma 16
Small Lymphocytic Lymphoma 15
Refractory Chronic Lymphocytic Leukemia 12
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Condition MeSH

Condition MeSH for IMBRUVICA
Intervention Trials
Lymphoma 78
Leukemia, Lymphoid 57
Leukemia, Lymphocytic, Chronic, B-Cell 55
Leukemia 54
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Clinical Trial Locations for IMBRUVICA

Trials by Country

Trials by Country for IMBRUVICA
Location Trials
United States 590
Japan 35
Spain 29
Australia 22
Italy 18
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Trials by US State

Trials by US State for IMBRUVICA
Location Trials
Texas 40
Ohio 38
California 36
New York 28
Massachusetts 27
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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 15
Phase 2/Phase 3 1
[disabled in preview] 134
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Clinical Trial Status

Clinical Trial Status for IMBRUVICA
Clinical Trial Phase Trials
Active, not recruiting 55
Recruiting 44
Completed 23
[disabled in preview] 26
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Clinical Trial Sponsors for IMBRUVICA

Sponsor Name

Sponsor Name for IMBRUVICA
Sponsor Trials
National Cancer Institute (NCI) 59
Pharmacyclics LLC. 30
M.D. Anderson Cancer Center 21
[disabled in preview] 34
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Sponsor Type

Sponsor Type for IMBRUVICA
Sponsor Trials
Other 135
Industry 119
NIH 61
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