Clinical Trial: Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed/Refractory Marginal Zone Lymphoma
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Multicenter, Open-Label, Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Relapsed/Refractory Marginal Zone Lymphoma
Brief Summary: Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of ibrutinib in subject with relapsed/refractory Marginal Zone Lymphoma (MZL).
Detailed Summary: Ibrutinib is a first-in-class, potent, orally administered covalent inhibitor of Bruton's tyrosine kinase (BTK). Inhibition of BTK blocks downstream B-cell receptor (BCR) signaling pathways and thus prevents B-cell proliferation. In vitro, ibrutinib inhibits purified BTK and selected members of the kinase family with 10-fold specificity compared with non-BTK kinases. Phase 1 and 2 studies of ibrutinib in B-cell malignancies demonstrate modest toxicity and significant single agent activity in a variety of B-cell malignancies, including NHL.
Sponsor: Pharmacyclics LLC.
Current Primary Outcome: ORR (Overall Response Rate) [ Time Frame: Analysis was conducted with the cutoff date of 05 July 2016, with a median follow-up time of 19.4 months. ]
Original Primary Outcome: To evaluate efficacy using the Overall Response Rate (ORR) in subjects with MZL [ Time Frame: 3 years ]
Current Secondary Outcome: DOR (Duration of Response) [ Time Frame: Analysis was conducted with the cutoff date of 05 July 2016, with a median follow-up time of 19.4 months. ]
Original Secondary Outcome:
- To evaluate efficacy parameter such as duration of response (DOR) to ibrutinib in subjects with MZL [ Time Frame: 3 years ]
- Frequency, severity, and relatedness of adverse events [ Time Frame: 3 years ]
- To determine the plasma pharmacokinetics of ibrutinib and the metabolite, PCI-45227 [ Time Frame: 3 years ]
- To evaluate efficacy parameter such as progression-free survival (PFS) to ibrutinib in subjects with MZL [ Time Frame: 3 years ]
- To evaluate efficacy parameter such as overall survival (OS) to ibrutinib in subjects with MZL [ Time Frame: 3 years ]
Information By: Pharmacyclics LLC.
Dates:
Date Received: October 29, 2013
Date Started: December 2013
Date Completion: February 2018
Last Updated: December 20, 2016
Last Verified: December 2016