RECRUITING

Selumetinib and Azacitidine in High Risk Chronic Blood Cancers

Conditions

Chronic Myeloid Leukemia Myelofibroses Myelofibrosis selumetinib azacitidine

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase I Study of MEK Inhibitor Selumetinib in Combination With Azacitidine in Patients With Higher Risk Chronic Myeloid Neoplasia: MDS, MDS/MPNs, and Myelofibrosis

Quick Facts

Study Start:2018-09-04

Study Completion:2025-09-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03326310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age greater than or equal to 18 years of age * Histologic confirmation of one of the following: * 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 * Adequate liver function, defined as conjugated bilirubin ≤ 2 x ULN as well as aspartate transaminase (AST) and alanine aminotransaminase (ALT) ≤ 3 x ULN * Patients must be at least 2 weeks from major surgery, radiation therapy, participation in other investigational trials and must have recovered from clinically significant toxicities of these prior treatments * Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment * Female and male patients must use an effective contraceptive method during the study and for at least 6 months thereafter * Ability to understand and willingness to sign a written informed consent document	* 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 * Active cardiac conditions, including any of the following: 1. Uncontrolled hypertension (BP \>150/95 mmHg despite medical therapy) 2. Acute coronary syndrome within 6 months prior to starting treatment 3. Uncontrolled angina despite medical therapy 4. Symptomatic heart failure (NYHA class II-IV despite medical therapy) 5. Baseline LV EF \<50% measured by either echocardiography or MUGA scan 6. Severe valvular heart disease 7. Atrial fibrillation with ventricular rate \>100 bpm on EKG at rest. * Ophthalmologic conditions, including any of the following: 1. Current or past history of central serous retinopathy 2. Current or past history of retinal vein occlusion 3. Intraocular pressure (IOP) \>21 mmHg or uncontrolled glaucoma * Any uncontrolled concurrent illness that, in the judgment of the investigators or treating physician, may put the patient at undo risk including but not limited to active infection, symptomatic cardiac or pulmonary disease, ventricular arrhythmia, or psychiatric illness. * Pregnant or lactating patients

Inclusion Criteria

Exclusion Criteria

* Age greater than or equal to 18 years of age
* Histologic confirmation of one of the following:
* 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
* Adequate liver function, defined as conjugated bilirubin ≤ 2 x ULN as well as aspartate transaminase (AST) and alanine aminotransaminase (ALT) ≤ 3 x ULN
* Patients must be at least 2 weeks from major surgery, radiation therapy, participation in other investigational trials and must have recovered from clinically significant toxicities of these prior treatments
* Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
* Female and male patients must use an effective contraceptive method during the study and for at least 6 months thereafter
* Ability to understand and willingness to sign a written informed consent document

* 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
* Active cardiac conditions, including any of the following:
1. Uncontrolled hypertension (BP \>150/95 mmHg despite medical therapy)
2. Acute coronary syndrome within 6 months prior to starting treatment
3. Uncontrolled angina despite medical therapy
4. Symptomatic heart failure (NYHA class II-IV despite medical therapy)
5. Baseline LV EF \<50% measured by either echocardiography or MUGA scan
6. Severe valvular heart disease
7. Atrial fibrillation with ventricular rate \>100 bpm on EKG at rest.
* Ophthalmologic conditions, including any of the following:
1. Current or past history of central serous retinopathy
2. Current or past history of retinal vein occlusion
3. Intraocular pressure (IOP) \>21 mmHg or uncontrolled glaucoma
* Any uncontrolled concurrent illness that, in the judgment of the investigators or treating physician, may put the patient at undo risk including but not limited to active infection, symptomatic cardiac or pulmonary disease, ventricular arrhythmia, or psychiatric illness.
* Pregnant or lactating patients

Contacts and Locations

Study Contact

Cancer Clinical Trials Office

CONTACT

1-855-702-8222

cancerclinicaltrials@bsd.uchicago.edu

Olatoyosi Odenike, MD

CONTACT

7737023354

todenike@medicine.bsd.uchicago.edu

Principal Investigator

Olatoyosi Odenike, MD

PRINCIPAL_INVESTIGATOR

University of Chicago

Study Locations (Sites)

The University of Chicago

Chicago, Illinois, 60637

United States

Collaborators and Investigators

Sponsor: University of Chicago

Olatoyosi Odenike, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-09-04

Study Completion Date2025-09-04

Study Record Updates

Study Start Date2018-09-04

Study Completion Date2025-09-04

Terms related to this study

Keywords Provided by Researchers

Chronic Myeloid Leukemia
Myelofibrosis
selumetinib
azacitidine

Additional Relevant MeSH Terms

Chronic Myeloid Leukemia
Myelofibroses