A Long-term Extension Study of PCI-32765 (Ibrutinib)
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ClinicalTrials.gov Identifier: NCT01804686 |
Recruitment Status :
Enrolling by invitation
First Posted : March 5, 2013
Last Update Posted : February 5, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Mantle Cell Lymphoma Follicular Lymphoma Diffuse Large B-cell Lymphoma Waldenstrom Macroglobulinemia Chronic Graft Versus Host Disease | Drug: PCI-32765 (Ibrutinib) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 700 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study |
Actual Study Start Date : | September 9, 2013 |
Estimated Primary Completion Date : | December 31, 2026 |
Estimated Study Completion Date : | December 31, 2026 |

Arm | Intervention/treatment |
---|---|
Experimental: PCI-32765 (Ibrutinib) |
Drug: PCI-32765 (Ibrutinib)
PCI-32765 (Ibrutinib) will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent PCI-32765 clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day. |
- Number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier ]
- Number of participants with change in disease status [ Time Frame: Up to the end-of-treatment visit (up to 30 days after the last dose of study medication), or until the start of a subsequent anti-caner therapy, if earlier ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants must be currently participating in a PCI-32765 clinical study considered complete and have received at least 6 months of treatment with PCI-32765. At study entry, participants must be actively receiving treatment with single-agent PCI-32765; or participants must have participated in a PCI-32765 randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior PCI-32765 treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments
- Investigator's assessment that the benefit of continued PCI-32765 therapy will outweigh the risks
- Agrees to protocol-defined use of effective contraception
- Negative blood or urine pregnancy test at screening
Exclusion Criteria:
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists
- Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor
- Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804686

Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT01804686 |
Other Study ID Numbers: |
CR100955 2012-004225-24 ( EudraCT Number ) PCI-32765CAN3001 ( Other Identifier: Janssen Research & Development, LLC ) |
First Posted: | March 5, 2013 Key Record Dates |
Last Update Posted: | February 5, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Device Product: | No |
Chronic lymphocytic leukemia Small lymphocytic lymphoma Mantle cell lymphoma Follicular lymphoma Diffuse large B-cell lymphoma |
PCI-32765 Ibrutinib Bruton's tyrosine kinase inhibitor IMBRUVICA JNJ-54179060 |
Lymphoma Lymphoma, Follicular Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, B-Cell Lymphoma, Mantle-Cell Lymphoma, Large B-Cell, Diffuse Waldenstrom Macroglobulinemia Graft vs Host Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Leukemia Lymphoma, Non-Hodgkin Leukemia, B-Cell Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |