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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

Must not have

Concurrent active malignancy, except early stage basal cell or squamous cell skin cancer

Active cardiac conditions including uncontrolled hypertension, acute coronary syndrome within 6 months, uncontrolled angina, symptomatic heart failure, baseline LV EF <50%, severe valvular heart disease, or atrial fibrillation with ventricular rate >100 bpm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of treatment to the first record of response, up to 100 months, whichever comes first.

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any cancer except for early-stage skin cancer.

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I have heart issues like uncontrolled high blood pressure or recent heart attacks.

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I do not have serious eye conditions like high eye pressure or uncontrolled glaucoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of treatment to the first record of response, up to 100 months, whichever comes first.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of treatment to the first record of response, up to 100 months, whichever comes first.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of treatment to the first record of response, up to 100 months, whichever comes first. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients with adverse events

Secondary study objectives

Rate of overall response.

Time to completion of next generation sequencing panel.

Side effects data

From 2012 Phase 2 trial • 37 Patients • NCT01085214

75%

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%

Hyponatremia

19%

Hypocalcemia

19%

Hypophosphatemia

19%

Edema, face

17%

Dry skin

17%

Alanine aminotransferase increased

14%

Hypokalemia

14%

Skin and subcutaneous tissue disorders - Other

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

Hypoglycemia

Anorexia

Acute kidney injury

Death, NOS

Periorbital edema

Skin hypopigmentation

Pain in extremity

Cough

Insomnia

Alkaline phosphatase increased

Dry mouth

Sepsis

Blood and lymphatic system disorders - Other

Hypernatremia

Metabolism and nutrition disorders - Other

Renal and urinary disorders - Other

Hypercalcemia

Dehydration

Musculoskeletal and connective tissue disorder - Other, Rhabdomyolysis

Chills

Hypotension

Myalgia

Arthralgia

Upper respiratory infection

Headache

Sinusitis

Generalized muscle weakness

Gastrointestinal disorders - Other

Gastroesophageal reflux disease

Vaginal inflammation

Confusion

Pruritus

Febrile neutropenia

Flu like symptoms

Hepatic failure

Skin infection

Fall

Fracture

Skin and subcutaneous tissue disorders - Other, Angular cheilitis, unilateral

Adult respiratory distress syndrome

Renal and urinary disorders - Other, Acute renal failure

INR increased

100%

80%

60%

40%

20%

Study treatment Arm

AZD6244 (Selumetinib) Treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active 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

~2080