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Anti-metabolites
Selumetinib + Azacitidine for Leukemia
Phase 1
Recruiting
Led By Olatoyosi Odenike, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate renal function defined as serum creatinine ≤ 1.5 x ULN or creatinine clearance >30 mL/min
Age greater than or equal to 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment to the date of death, not to exceed 100 months, whichever comes first.
Awards & highlights
Study Summary
This trial is testing a new cancer drug (selumetinib) to see if it is safe when combined with the standard dose of another cancer drug (azacitidine). The study will last about 24 months, and patients will be taken off the study if they experience disease progression, unacceptable toxicity, or other illnesses.
Who is the study for?
Adults with high-risk chronic blood cancers like Myeloid Leukemia, who haven't been treated with MEK inhibitors before, can join. They should have certain levels of disease severity and organ function, no recent cancer treatments except possibly hydroxyurea, and not be pregnant or breastfeeding. Participants must use effective birth control.Check my eligibility
What is being tested?
The trial is testing the combination of Selumetinib and Azacitidine to find the maximum tolerated dose. It's an early-phase study where patients receive treatment within 28 days after screening and continue indefinitely if beneficial, unless they experience unacceptable side effects or choose to leave.See study design
What are the potential side effects?
Potential side effects may include reactions related to liver or kidney function changes, fatigue from low blood counts, gastrointestinal issues like nausea or constipation, skin reactions at injection sites, and increased risk of infections due to weakened immune systems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the normal range.
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I am 18 years old or older.
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My MDS is high-risk or has come back and needs treatment.
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I have never been treated with a MEK inhibitor.
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I can take care of myself and do some daily activities.
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My liver tests are within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of treatment to the date of death, not to exceed 100 months, whichever comes first.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment to the date of death, not to exceed 100 months, whichever comes first.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with adverse events
Secondary outcome measures
Rate of overall response.
Rate of overall survival.
Rate of progression free survival.
+2 moreSide effects data
From 2012 Phase 2 trial • 37 Patients • NCT0108521475%
Diarrhea
50%
Fatigue
47%
Anemia
47%
Rash acneiform
44%
Hypoalbuminemia
44%
Edema, limbs
39%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
33%
White blood cell decreased
31%
Nausea
31%
Vomiting
28%
Platelet count decreased
25%
CPK increased
25%
Hypomagnesemia
22%
Hypertension
19%
Hypophosphatemia
19%
Hypocalcemia
19%
Hyponatremia
19%
Edema, face
17%
Dry skin
17%
Alanine aminotransferase increased
14%
Skin and subcutaneous tissue disorders - Other
14%
Hypokalemia
14%
Creatinine increased
14%
Back pain
14%
Dyspnea
14%
Lymphocyte count decreased
11%
Pain
11%
Fever
11%
Localized edema
11%
Peripheral sensory neuropathy
11%
Hyperkalemia
11%
Dizziness
11%
Abdominal pain
8%
Acute kidney injury
8%
Hypoglycemia
8%
Anorexia
8%
Death, NOS
8%
Periorbital edema
8%
Skin hypopigmentation
8%
Pain in extremity
8%
Cough
8%
Insomnia
8%
Alkaline phosphatase increased
8%
Dry mouth
8%
Sepsis
6%
Renal and urinary disorders - Other
6%
Dehydration
6%
Musculoskeletal and connective tissue disorder - Other, Rhabdomyolysis
6%
Hypernatremia
6%
Blood and lymphatic system disorders - Other
6%
Hypercalcemia
6%
Metabolism and nutrition disorders - Other
6%
Chills
6%
Hypotension
6%
Myalgia
6%
Arthralgia
6%
Upper respiratory infection
6%
Headache
6%
Sinusitis
6%
Generalized muscle weakness
6%
Gastrointestinal disorders - Other
6%
Gastroesophageal reflux disease
3%
Confusion
3%
Vaginal inflammation
3%
Pruritus
3%
Febrile neutropenia
3%
Flu like symptoms
3%
Hepatic failure
3%
Skin infection
3%
Fall
3%
Fracture
3%
Skin and subcutaneous tissue disorders - Other, Angular cheilitis, unilateral
3%
Adult respiratory distress syndrome
3%
Renal and urinary disorders - Other, Acute renal failure
3%
INR increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
AZD6244 (Selumetinib) Treatment
Trial Design
1Treatment groups
Experimental Treatment
Group I: Azacitidine and selumetinibExperimental Treatment2 Interventions
Subjects will receive azacitidine subcutaneously on days 1-7. Selumetinib will be administered on days 8-21. Subjects will continue on this schedule in cycles of 28 days duration in the absence of disease progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
2012
Completed Phase 3
~1440
Selumetinib
2010
Completed Phase 2
~2050
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,759 Total Patients Enrolled
21 Trials studying Leukemia
1,129 Patients Enrolled for Leukemia
Olatoyosi Odenike, MDPrincipal InvestigatorUniversity of Chicago
2 Previous Clinical Trials
76 Total Patients Enrolled
1 Trials studying Leukemia
26 Patients Enrolled for Leukemia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My myelofibrosis is high risk, and I can't tolerate or didn't respond to JAK inhibitor therapy.I can take care of myself and do some daily activities.My liver tests are within the required range.My kidney function is within the normal range.I haven't taken any cancer treatments in the last 14 days, except hydroxyurea.I do not have any cancer except for early-stage skin cancer.I have heart issues like uncontrolled high blood pressure or recent heart attacks.I am 18 years old or older.My MDS is high-risk or has come back and needs treatment.My MDS/MPN condition is worsening and needs treatment, but no standard treatments are available.I do not have serious eye conditions like high eye pressure or uncontrolled glaucoma.I have never been treated with a MEK inhibitor.I have recovered from any major surgery or treatment side effects and it's been over 2 weeks since these treatments.I am a woman who can have children and have a recent negative pregnancy test.I will use effective birth control during and for 6 months after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Azacitidine and selumetinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What indications are Selumetinib normally prescribed to treat?
"Selumetinib is commonly prescribed as an induction chemotherapy and also to address cases of refractory anemias, leukemia, myelocytic, acute, multilineage dysplasia."
Answered by AI
Are there currently enrollees to this research experiment?
"Affirmative. The data hosted on clinicaltrials.gov affirms that this research endeavour is actively looking for participants, with the original posting having been made on September 4th 2018 and a recent update occurring on May 16th 2022. 18 individuals are desired from one medical centre."
Answered by AI
What is the current enrollment size for this trial?
"Affirmative. The information hosted on clinicaltrials.gov demonstrates that this research project, which was first announced on September 4th 2018, is currently accepting participants. 18 individuals need to be sourced from a single medical site in total."
Answered by AI
Is there a corpus of literature analyzing the effects of Selumetinib?
"At present, 207 clinical studies are examining Selumetinib. Of these investigations, 37 have progressed to Phase 3. The majority of research is conducted in Saint Louis, Missouri; however other trial sites can be found across the country with a total of 6675 locations offering this treatment."
Answered by AI
Has Selumetinib received clearance from the Food and Drug Administration?
"As this is a Phase 1 trial, the safety of Selumetinib has been preliminarily assessed and assigned a score of 1. This rating reflects the limited data available concerning efficacy and safety."
Answered by AI
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