Clinical Trials /

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

NCT03229200

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.

Related Conditions:
  • Hematopoietic and Lymphoid Malignancy
  • Malignant Solid Tumor
Recruiting Status:

Enrolling by invitation

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.
  • Official Title: Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.

Clinical Trial IDs

  • ORG STUDY ID: PCYC-1145-LT
  • NCT ID: NCT03229200

Conditions

  • Lymphoma, B-Cell
  • Lymphoma, Non-Hodgkin
  • Leukemia, B-cell
  • Graft Vs Host Disease
  • Solid Tumor

Interventions

DrugSynonymsArms
IbrutinibIbrutinib

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
IbrutinibExperimentalTreatment with Ibrutinib, once daily until disease progression or unacceptable toxicity.
  • Ibrutinib

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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.
Safety Issue:
Description:Assessment of percentage of patients rolling over from each parent study.

Secondary Outcome Measures

Measure:Characterize the drug safety profile by collecting long-term safety data for ibrutinib.
Time Frame:Up to 3 years and will be re-evaluated.
Safety Issue:
Description:Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0.

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Pharmacyclics Switzerland GmbH

Last Updated

March 6, 2018