This 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 advanced myeloid malignancies; 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 chronic idiopathic myelofibrosis (CIMF).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
SB1518 taken orally daily for 28 consecutive days in a 28-day cycle
The University of Chicago Hospitals
Chicago, Illinois, United States
MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Phase 1: To establish the maximum tolerated dose of SB1518 as a single agent when administered orally daily in subjects with advanced myeloid malignancies
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 once daily in subjects with advanced myeloid malignancies
Time frame: Throughout the study
Assess the pharmacokinetic and pharmacodynamic profile of SB1518
Time frame: Throughout the study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.