A Phase 1 Open-Label, Multicenter, Dose-Escalation Study of PRN1371, a FGFR1-4 Kinase Inhibitor, in Adult Patients with Advanced Solid Tumors, followed by an Expansion Cohort in Patients with FGFR1, 2, 3, or 4 Genetic Alterations (Protocol No.: PRN1371-001)
Johns Hopkins Kimmel Cancer Center in Baltimore
To investigate the safety and tolerability of PRN1371 in patients with advanced solid tumors; to determine the maximum tolerated dose of PRN1371
Histological or cytological documentation of an advanced solid tumor. Tumor specimens must be available for retrospective confirmation and central FGFR evaluation.
The use of a conventional algorithm (3+3 patients per dose level) to identify the MTD and/or a lower recommended phase 2 dose level of PRN1371 that can safely be administered in consecutive 28 day cycles. Dose cohorts will be filled sequentially and dose- escalated when all patients at a given dose level complete Cycle 1 with acceptable tolerability and after review of the clinical data.No control group will be utilized since the primary objectives of the study are to evaluate the safety, tolerability, PK profile, pharmacodynamics effects, and clinical activity of PRN1371 in a relapsed/refractory population for whom no standard treatment is available.
03/05/2019 05:03 AM