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Anti-metabolite

Azacitidine + Quizartinib for Myelodysplastic Syndrome

Phase 1 & 2

Recruiting

Led By Guillermo M Bravo

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

For patients with prior hypomethylating agent therapy: no response after 6 cycles of azacitidine, decitabine, guadecitabine or ASTX727 or relapse or progression after any number of cycles

Must not have

Patients with congenital long QT syndrome

Patients known to be positive for hepatitis B surface antigen expression or with active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months). Patients with history of human immunodeficiency virus (HIV) disease are also excluded from the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of quizartinib when given with azacitidine to people with myelodysplastic syndrome or myelodysplastic/myeloproliferative neoplasm with FLT3 or CBL mutations.

Who is the study for?

This trial is for adults with myelodysplastic syndrome or related conditions, who have specific FLT3 or CBL mutations. It's open to those new to treatment and those who didn't respond to previous therapies. Participants should be in decent health otherwise, with acceptable organ function and no severe heart issues.

What is being tested?

The trial is testing the combination of two drugs: Azacitidine, a chemotherapy drug that stops cancer cells from growing, and Quizartinib, which blocks enzymes needed by cancer cells. The study aims to find the best dose and see how well these drugs work together against certain blood disorders.

What are the potential side effects?

Potential side effects may include typical chemotherapy-related reactions like nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems. Heart rhythm disturbances could also occur due to Quizartinib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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I did not respond to or my condition worsened after treatment with specific agents.

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I have been diagnosed with MDS or a related condition.

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My cancer has a specific genetic mutation (FLT3-ITD or CBL).

Exclusion Criteria

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

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I have congenital long QT syndrome.

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I do not have active hepatitis B, hepatitis C, or HIV.

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I have had a heart attack in the last 6 months or have uncontrolled heart problems.

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My heart's pumping ability is significantly reduced.

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I am a woman who can have children and have not had a negative pregnancy test.

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I am not currently on any experimental treatments or undergoing chemotherapy, radiotherapy, or immunotherapy.

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I am currently taking medication that strongly affects liver enzyme activity.

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I have had a heart rhythm problem that needed treatment.

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I am not pregnant or breastfeeding.

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I have an infection that isn't getting better with antibiotics.

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I have a history of serious irregular heartbeats.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Duration of response

Incidence of adverse events (AEs)

Leukemia free survival

+3 more

Side effects data

From 2020 Phase 3 trial • 367 Patients • NCT02039726

47%

Nausea

37%

Pyrexia

36%

Anemia

33%

Vomiting

32%

Hypokalemia

28%

Diarrhea

28%

Fatigue

26%

Thrombocytopenia

26%

Electrocardiogram QT prolonged

23%

Cough

21%

Febrile neutropenia

21%

Edema peripheral

21%

Headache

20%

Decreased appetite

20%

Dyspnea

20%

Neutropenia

20%

Constipation

16%

Stomatitis

15%

Hypomagnesemia

15%

Rash

15%

Dizziness

15%

White blood cell count decreased

14%

Asthenia

14%

Platelet count decreased

13%

Hypotension

13%

Alanine aminotransferase increased

13%

Neutrophil count decreased

12%

Epistaxis

12%

Abdominal pain

11%

Weight decreased

11%

Hypocalcemia

11%

Aspartate aminotransferase increased

11%

Petechiae

11%

Back pain

10%

Hypophosphatemia

10%

Blood bilirubin increased

10%

Oropharyngeal pain

10%

Pain in extremity

Dysgeusia

Hyponatremia

Pneumonia

Insomnia

Musculoskeletal pain

Anxiety

Arthralgia

Muscle spasms

Dyspepsia

Pain

Urinary tract infection

Hypoalbuminemia

Graft versus host disease in skin

Upper respiratory tract infection

Sepsis

Blood alkaline phosphatase increased

Blood creatinine increased

Gingival bleeding

Abdominal pain upper

Hyperglycemia

Dysuria

Skin lesion

Graft versus host disease

Chills

Contusion

Leukocytosis

Pruritis

Myalgia

Pleural effusion

Dry mouth

Dry eye

Leukopenia

Abdominal distension

Device related infection

Hypertension

Nasal congestion

Neutropenic sepsis

Sinus tachycardia

Confusional state

Proctalgia

Cellulitis

Septic shock

Hemorrhage intracranial

Bacteremia

Graft versus host disease in intestine

Syncope

Staphylococcal infection

Escherichia sepsis

Skin infection

Acute febrile neutrophilic dermatosis

Rash generalized

Cerebral hemorrhage

Clostridium difficile infection

Klebsiella sepsis

Lung infection

Pneumonia fungal

Staphylococcal bacteremia

Hematuria

Atrial fibrillation

Pericarditis

Pneumonitis

Respiratory failure

Pancytopenia

Enterobacter infection

Infection

Gastroenteritis

Neutropenic infection

100%

80%

60%

40%

20%

Study treatment Arm

Quizartinib

Salvage Chemotherapy

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: Treatment (azacitidine, quizartinib)Experimental Treatment2 Interventions

Patients receive azacitidine SC or IV over about 30 minutes on days 1-5 and quizartinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Quizartinib

2016

Completed Phase 3

~1130

Azacitidine

2012

Completed Phase 3

~1440