CLINICAL TRIALS PROFILE FOR IMBRUVICA
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505(b)(2) Clinical Trials for IMBRUVICA
| 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 | >Sponsor | >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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for IMBRUVICA
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