Selumetinib and Azacitidine in High Risk Chronic Blood Cancers

PHASE1RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

September 4, 2018

Primary Completion Date

September 4, 2025

Study Completion Date

September 4, 2025

Conditions
Chronic Myeloid LeukemiaMyelofibroses
Interventions
DRUG

Azacitidine

"Patients will receive azacitidine 75 mg/m2 as a subcutaneous injection on days 1-7. The dose of azacitidine 75 mg/m2 will remain unchanged, unless a dose reduction is required based on toxicities (dose level -1 = selumetinib 50 mg PO twice daily and azacitidine 50 mg/m2).~Subjects will continue on this schedule in cycles of 28 days duration in the absence of disease progression"

DRUG

Selumetinib

"Patients will receive selumetinib administered by mouth on days 8-21. The starting dose cohort (dose level 1) will receive selumetinib 50 mg PO twice daily on days 8-21. Subsequent planned doses include selumetinib 75 mg PO twice daily (dose level 2) and selumetinib 100 mg PO twice daily (dose level 3). Subsequent dose levels will only be given once the prior dose level has shown acceptable safety.~Subjects will continue on this schedule in cycles of 28 days duration in the absence of disease progression."

Trial Locations (1)

60637

RECRUITING

The University of Chicago, Chicago

All Listed Sponsors
lead

University of Chicago

OTHER

NCT03326310 - Selumetinib and Azacitidine in High Risk Chronic Blood Cancers | Biotech Hunter | Biotech Hunter