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Title:
A Phase 1b/2 Dose-Escalation and Cohort-Expansion Study of the Noncovalent, Reversible Bruton’s Tyrosine Kinase Inhibitor, SNS-062, in Patients With B-Lymphoid Malignancies
Protocol Number:
J1915
Phase:
Phase I/II
Physician:
Douglas Gladstone
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
This research is being done to study the investigational drug known as vecabrutinib (SNS-062) to determine its safety profile and recommended dose and to evaluate how the disease responds to this study drug.
Eligibility:
Men and women of age minimum of 18 years with confirmed relapsed/ refractory disease are eligible. Participants should have been received at least 2 lines of systemic therapy including prior BTK (Bruton's Tyrosine Kinase) inhibitor therapy to be eligible. Participants with transformed disease, active CNS involvement, significant cardiovascular disease, gastrointestinal disease, high risk of bleeding, uncontrolled systemic infections, transplant, pregnant or nursing (lactating) women are not allowed to participate.
Treatment:
This is a Phase 1b/2, open label, dose escalation study. The eligible participants will receive the study drug and it is administered orally. The number of times you need to visit the study center will decrease the longer you participate in this study. This study will last up to approximately 2 years.
Population:
Adult
Last Update
08/08/2020 05:02 AM