Study design
lymphoma, toxicity, lymphoid malignancies, DLBCL
LYMPHOMA, DISEASE PROGRESSION, CLL, SOLID TUMORS
This was an open-label, multicenter, phase I, dose escalation and expansion study of QD, oral, single-agent mivavotinib in patients with advanced solid tumors or lymphoid malignancies. The full study design and methods have previously been reported [Briefly, in the dose escalation phase, adults with a confirmed diagnosis of lymphoma for which no standard treatment was available were enrolled to receive escalating doses of oral mivavotinib (60 mg, 80 mg, 100 mg or 120 mg QD) in an accelerated 3+3 dose escalation design. In the expansion phase, patients with lymphoid malignancies received mivavotinib 100 mg QD (the MTD from the dose escalation phase) in one of six disease-specific cohorts: CLL, iNHL, MCL, EBV+PTLD and two separate DLBCL expansion cohorts. All patients in the escalation and expansion phases received oral mivavotinib at their assigned dosage in continuous 28-day cycles until disease progression or unacceptable toxicity.