Long-term Study of Ibrutinib for Ongoing Access and Safety Monitoring
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT01804686
This study aims to provide continued access to the drug ibrutinib for patients who have been part of previous ibrutinib studies and are still benefiting from the treatment. It also collects long-term safety and effectiveness data.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study is designed to allow patients who have been part of previous ibrutinib studies to continue receiving the drug if they are still benefiting from it. Ibrutinib is a medication taken by mouth that targets a specific protein involved in cancer cell growth. The study will monitor the safety of ibrutinib over a long period and gather information on how well it continues to work for patients. Patients will keep taking their current dose of ibrutinib until it no longer helps them, they choose to stop, or they can access the drug through other means. The study will end when all patients have either stopped taking ibrutinib or have found another way to get it.
Description
This study allows patients who have been in previous ibrutinib studies to keep taking the drug if it is still helping them. Ibrutinib is a medication that targets a protein called Bruton's tyrosine kinase, which is involved in the growth of cancer cells. Patients will continue with their current dose of ibrutinib until it no longer benefits them, they decide to stop, or they can get the drug through other means. The study will monitor the safety of ibrutinib and collect data on its effectiveness over time. The study will end when all patients have either stopped taking ibrutinib or have found another way to access it.
Eligibility Criteria
Inclusion Criteria
- Currently participating in a completed ibrutinib study and have received at least 6 months of treatment with ibrutinib.
- Actively receiving treatment with ibrutinib alone or in combination with nivolumab.
- Investigator believes the benefits of continuing ibrutinib outweigh the risks.
- Agree to use effective contraception as defined by the study.
- Negative pregnancy test for women of childbearing potential.
Exclusion Criteria
- Need to take blood thinners like warfarin.
- Need to take certain medications that affect how ibrutinib works, unless approved by the study sponsor.
- Any condition that the study doctor believes could put the patient at risk or interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Cancer Center | 91010 | Duarte | California |
| University of California San Diego Medical Center | 92093 | La Jolla | California |
| University of California Los Angeles | 90095 | Los Angeles | California |
| St. Joseph Hospital Center for Cancer Prevention and Treatment | 92868 | Orange | California |
| Stanford University Medical Center | 94305 | Stanford | California |
| Stanford University | 94305 | Stanford | California |
| Norwalk Medical Group | 06850 | Norwalk | Connecticut |
| Northwest Georgia Oncology Centers PC | 30060 | Marietta | Georgia |
| Northwestern University Hospital | 60611 | Chicago | Illinois |
| Indiana University | 46526 | Goshen | Indiana |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.