At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Histologically confirmed MDS (IPSS intermediate-2/high or IPSS-R intermediate/high/very high risk), relapsed/refractory with cytopenias or excess blasts
- ✓MDS/MPN (including CMML, atypical CML, MDS/MPN-Unclassifiable), relapsed/refractory or treatment-naive with no approved therapies
- ✓Myelofibrosis (primary, post-PV, or post-ET), intermediate-2/high risk DIPSS, refractory/intolerant to JAK inhibitor or ineligible for ruxolitinib
- ✕Anti-cancer therapy within 14 days prior to study entry (except hydroxyurea)
- ✕Concurrent active malignancy (except early stage basal/squamous cell skin cancer)
- ✕Uncontrolled hypertension (BP >150/95 mmHg despite medical therapy)
- ✕Acute coronary syndrome within 6 months prior to treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Study of MEK Inhibitor Selumetinib in Combination With Azacitidine in Patients With Higher Risk Chronic Myeloid Neoplasia: MDS, MDS/MPNs, and Myelofibrosis
In Brief
A Phase 1 clinical trial evaluating Azacitidine and Selumetinib for Chronic Myeloid Leukemia and Myelofibroses. Currently recruiting, targeting 18 participants across 1 site.
Detailed Summary
This is a phase I, open-label, dose-escalation study to determine the MTD of selumetinib when combined with the standard dose of azacitidine. Treatment will begin within 28 days of screening procedures. Treatment will continue indefinitely, provided that the patient continues to derive benefit. A patient will be taken off study for reasons described in detail in section 3.12 including disease progression, unacceptable toxicity, inter-current illness, withdrawal of consent, or at the discretion of the investigator. Patients will be followed for 12 weeks after the last dose of study drug, until any study treatment related toxicities have stabilized, or until death. The total duration of the study is expected to be approximately 24 months.
Study Details
Timeline
Interventions
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
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.