Selumetinib and Azacitidine in High Risk Chronic Blood Cancers
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: All of the following criteria must be met: * Age greater than or equal to 18 years of age * Histologic confirmation of one of the following: a. MDS fulfilling all the criteria below: i. International Prognostic Scoring System (IPSS) intermediate-2 or high risk MDS; or Revised International Prognostic Scoring System (IPSS-R) intermediate, high, or very high risk MDS ii. - relapsed/refractory disease iii. Requiring therapy based on the presence of one or more cytopenias (Hb \<10 g/dL and/or red cell transfusion dependence, platelets- \<50,000/μL, or ANC \<1,000/ μL) or excess blasts (≥5% in the peripheral blood or bone marrow). b. MDS/MPN as defined by the WHO criteria, including CMML, atypical CML, and MDS/MPN-Unclassifiable fulfilling the criteria listed below i. relapsed/refractory disease ii. Requiring therapy based on the presence of one or more cytopenias (Hb \<10 g/dL and/or red cell transfusion dependence, platelets \<50,000/μL, or ANC \<1,000/ μL), excess bla