Selumetinib and Azacitidine in High Risk Chronic Blood Cancers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
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
Qualifiers
Age greater than or equal to 18 years of age
No history of prior exposure to a MEK inhibitor
ECOG performance status of ≤ 2
Adequate renal function, defined as serum creatinine ≤ 1.5 x ULN or creatinine clearance >30 mL/min based on the Cockroft-Gault equation: (140 - Age) x (weight in kg) x (0.85 if female) / 72 x serum creatinine
Disqualifiers
Receipt of any anti-cancer therapy within 14 days prior to study entry, with the exception of hydroxyurea. If clinically indicated in order to keep WBC <30,000/uL, hydroxyurea may be continued through the first cycle.
Concurrent active malignancy, with the exception of early stage basal cell or squamous cell skin cancer
Uncontrolled hypertension (BP >150/95 mmHg despite medical therapy)
Acute coronary syndrome within 6 months prior to starting treatment
Trial design
Treatments tested in this trial
- Azacitidine
- Selumetinib
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov