Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
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| ClinicalTrials.gov Identifier: NCT03229200 |
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Recruitment Status :
Enrolling by invitation
First Posted : July 25, 2017
Last Update Posted : November 23, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma, B-Cell Lymphoma, Non-Hodgkin Leukemia, B-cell Graft Vs Host Disease Solid Tumor | Drug: Ibrutinib | Phase 4 |
Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.
Subjects enrolled in this treatment protocol will receive oral continuous dosing with ibrutinib at the same dose and schedule they were receiving at the end of the respective parent study. Treatment may be continued as long as the subjects continue to derive benefit from treatment with ibrutinib until such time that ibrutinib becomes commercially available for the indication of the parent study.
Clinical evaluations (including safety assessments) will be performed per local standard of care for each disease that was studied in the parent protocol. At each visit, all ongoing and new onset non-serious AEs leading to dose reduction or discontinuation, serious adverse events (SAEs), adverse events of special interest (AESI), pregnancy events, other malignancies, and special reporting situations will be recorded.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials. |
| Actual Study Start Date : | May 22, 2017 |
| Estimated Primary Completion Date : | July 2, 2027 |
| Estimated Study Completion Date : | July 2, 2027 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ibrutinib
Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.
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Drug: Ibrutinib
Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study. |
- The objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib for subjects who meet the selection criteria. [ Time Frame: The duration will be 3 years and will be re-evaluated. ]Assessment of percentage of patients rolling over from each parent study.
- Characterize the drug safety profile by collecting long-term safety data for ibrutinib. [ Time Frame: Up to 3 years and will be re-evaluated. ]Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject must currently be participating in an ibrutinib clinical trial, deriving clinical benefit from treatment with ibrutinib in the opinion of the treating physician and do not have access to commercial ibrutinib within their region.
- Ongoing continuous treatment with ibrutinib.
- Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib.
- Subject has provided informed consent.
- Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control and a barrier method during the period of therapy and for 90 days after the last dose of drug.
Exclusion Criteria:
- Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment.
- Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject's participation in the protocol.
- Female subjects who are pregnant, or breastfeeding, or planning to become pregnant. Male subjects who plan to father a child while enrolled in this protocol.
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): NCT03229200
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| Study Director: | Edyta Dobkowska, MD | Pharmacyclics LLC. |
| Responsible Party: | Pharmacyclics Switzerland GmbH |
| ClinicalTrials.gov Identifier: | NCT03229200 |
| Other Study ID Numbers: |
PCYC-1145-LT |
| First Posted: | July 25, 2017 Key Record Dates |
| Last Update Posted: | November 23, 2022 |
| Last Verified: | November 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Leukemia, B-Cell Graft vs Host Disease Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, Lymphoid Leukemia |