Overview

This trial is active, not recruiting.

Conditions marginal zone lymphoma, b-cell lymphoma
Treatment ibrutinib
Phase phase 2
Target BTK
Sponsor Pharmacyclics LLC.
Collaborator Janssen Research & Development, LLC
Start date December 2013
End date July 2016
Trial size 63 participants
Trial identifier NCT01980628, PCYC-1121-CA

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ibrutinib capsules: 560 mg once daily
ibrutinib

Primary Outcomes

Measure
To evaluate efficacy using the Overall Response Rate (ORR) as assessed by an Independent Review Committee (IRC) in subjects with MZL
time frame: At the earliest, 52 weeks after last patient enrolled

Secondary Outcomes

Measure
To evaluate efficacy parameter such as duration of response (DOR) to ibrutinib in subjects with MZL
time frame: At the earliest, 52 weeks after last patient enrolled
Frequency, severity, and relatedness of adverse events
time frame: At the earliest, 52 weeks after last patient enrolled
To determine the plasma pharmacokinetics of ibrutinib and the metabolite, PCI-45227
time frame: At the earliest, 52 weeks after last patient enrolled
To evaluate efficacy parameter such as progression-free survival (PFS) to ibrutinib in subjects with MZL
time frame: At the earliest, 52 weeks after last patient enrolled
To evaluate efficacy parameter such as overall survival (OS) to ibrutinib in subjects with MZL
time frame: At the earliest, 52 weeks after last patient enrolled

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion criteria: - Histologically documented marginal zone lymphoma including splenic, nodal, and extranodal sub-types; subjects with splenic MZL must have an additional measurable lesion, nodal or extranodal, as described in inclusion criteria 5 - Previously received one or more lines of therapy including at least one CD20-directed regimen (either as monotherapy or as chemoimmunotherapy) with documented failure to achieve at least PR or documented PD after, the most recent systemic treatment regimen - Men and women ≥18 years of age - ECOG performance status of ≤2 - ≥1 measurable lesion site on CT scan (>1.5 cm in longest dimension). Lesions in anatomical locations (such as extremities or soft tissue lesions) that are not well visualized by CT may be measured by MRI instead. (Subjects with spleen-only disease are considered as not having measurable disease.) - Life expectancy of >3 months, in the opinion of the investigator Key Exclusion criteria: - Medically apparent CNS lymphoma or leptomeningeal disease - History of other malignancies except adequately treated non melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥2 years - History of allogeneic stem-cell (or other organ) transplantation - Any chemotherapy, anticancer antibodies, or other systemic anticancer therapy within 21 days of the first dose of study drug - Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug - Concurrent use of warfarin or other vitamin K antagonists - Concurrent use of a strong CYP3A inhibitor. Subjects who have received a strong CYP3A inhibitor prior to entering the study must have discontinued therapy for at least 5 half lives of the prohibited medication. - Recent infection requiring IV anti-infective treatment that was completed ≤14 days before the first dose of study drug - Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to CTCAE Grade 0 or 1, or to the levels dictated in the eligibility criteria with the exception of alopecia - Inadequate organ function as defined on laboratory tests

Additional Information

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
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Pharmacyclics LLC..