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Trial record 12 of 319 for:    IBRUTINIB

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03229200
Recruitment Status : Enrolling by invitation
First Posted : July 25, 2017
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Pharmacyclics Switzerland GmbH

Tracking Information
First Submitted Date  ICMJE June 5, 2017
First Posted Date  ICMJE July 25, 2017
Last Update Posted Date October 21, 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
 (submitted: July 24, 2017)
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.
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
 (submitted: July 24, 2017)
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, B-Cell
  • Lymphoma, Non-Hodgkin
  • Leukemia, B-cell
  • Graft Vs Host Disease
  • Solid Tumor
Intervention  ICMJE Drug: Ibrutinib
Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.
Study Arms  ICMJE Experimental: Ibrutinib
Treatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.
Intervention: Drug: Ibrutinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: July 24, 2017)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Pharmacyclics Switzerland GmbH
Study Sponsor  ICMJE Pharmacyclics Switzerland GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bernhard Hauns, MD Pharmacyclics LLC.
PRS Account Pharmacyclics Switzerland GmbH
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP