Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
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ClinicalTrials.gov Identifier: NCT03229200 |
Recruitment Status :
Enrolling by invitation
First Posted : July 25, 2017
Last Update Posted : December 9, 2019
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Tracking Information | |||||
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First Submitted Date ICMJE | June 5, 2017 | ||||
First Posted Date ICMJE | July 25, 2017 | ||||
Last Update Posted Date | December 9, 2019 | ||||
Actual Study Start Date ICMJE | May 22, 2017 | ||||
Estimated Primary Completion Date | July 2, 2027 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT03229200 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib. | ||||
Official Title ICMJE | Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials. | ||||
Brief Summary | 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. | ||||
Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Ibrutinib
Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.
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Study Arms ICMJE | Experimental: Ibrutinib
Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.
Intervention: Drug: Ibrutinib
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Enrolling by invitation | ||||
Estimated Enrollment ICMJE |
500 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 2, 2027 | ||||
Estimated Primary Completion Date | July 2, 2027 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Belgium, Canada, Czechia, France, Greece, Israel, Italy, New Zealand, Poland, Russian Federation, Spain, Sweden, Turkey, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03229200 | ||||
Other Study ID Numbers ICMJE | PCYC-1145-LT | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pharmacyclics Switzerland GmbH | ||||
Study Sponsor ICMJE | Pharmacyclics Switzerland GmbH | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pharmacyclics Switzerland GmbH | ||||
Verification Date | December 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |