The study consists of two phases: The first portion of the study is a Phase 1 dose escalation study to determine the maximum tolerated dose and the dose limiting toxicities of SB1518 when given as a single agent orally once daily in subjects with Chronic Idiopathic Myelofibrosis (CIMF) regardless of their JAK2 mutational status. The second portion of the study is a Phase 2 study to define the efficacy and safety profile of single agent SB1518 at the recommended dose in subjects with CIMF.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
SB1518 taken orally daily for 28 consecutive days in a 28-day cycle
Mayo Clinic
Scottsdale, Arizona, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Royal Adelaide Hospital
Adelaide, Australia
Phase 1: to establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily
Time frame: Throughout the study
Phase 2: to assess the clinical benefit rate in subjects with CIMF who are treated with SB1518 at the recommended dose
Time frame: Throughout the study
Assess the safety and tolerability of SB1518, administered orally once daily in subjects with CIMF
Time frame: Throughout the study
Assess the pharmacokinetic profile of SB1518
Time frame: Throughout the study
Assess the pharmacodynamic profile of SB1518
Time frame: Throughout the study
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