This is a phase 1b/2 study of KRT-232 combined with ruxolitinib in subjects with MF who have a suboptimal response after at least 18 weeks of treatment with ruxolitinib. The primary objective of the study is to determine a recommended phase 2 dose (RP2D) of KRT 232 in combination with ruxolitinib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
administered by mouth
administered by mouth
City of Hope
Duarte, California, United States
RECRUITINGJohn Hopkins University
Baltimore, Maryland, United States
RECRUITINGUniversity of Michigan
Ann Arbor, Michigan, United States
RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
For Phase 1: To determine the KRT-232 RP2D in combination with ruxolitinib
Dose limiting toxicities will be used to establish the MTD of KRT-232 in combination with ruxolitinib. Subsequently, RP2D will be based on safety and efficacy data of the combination.
Time frame: 15 months
For Phase 2:To determine the spleen volume reduction (SVR) at Week 24
The proportion of subjects achieving SVR of ≥ 35% at Week 24 by MRI/CT scan
Time frame: 6 months after last patient enrolled
To determine spleen response
The proportion of subjects achieving ≥35% SVR at any time point from Baseline while on study, as assessed by MRI (or by CT scan for applicable subjects)
Time frame: 43 months
To determine the change in Total Symptom Score (TSS) based Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0)
The percentage change in TSS as measured by the MFSAF v4.0 at any time point from Baseline while on study
Time frame: 43 months
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Cleveland Clinic
Cleveland, Ohio, United States
RECRUITINGFox Chase Cancer Center
Philadelphia, Pennsylvania, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGFred Hutchinson Cancer Research Center
Seattle, Washington, United States
RECRUITINGRoyal Adelaide Hospital
Adelaide, Australia
RECRUITINGDr. Georgi Stranski
Pleven, Bulgaria
RECRUITING...and 28 more locations