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A Phase II Study of Sunitinib Malate (Sutent®; SU11248) in Patients With Intermediate-2 or High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Phase 2
18 Years
Not Enrolling
Chronic Myelomonocytic Leukemia, de Novo Myelodysplastic Syndromes, Myelodysplastic Syndromes, Secondary Myelodysplastic Syndromes

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Trial Information

A Phase II Study of Sunitinib Malate (Sutent®; SU11248) in Patients With Intermediate-2 or High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia


I. Determine the overall response rate (complete response, partial response, or
hematological improvement) in patients with intermediate-2 or high-risk myelodysplastic
syndromes or chronic myelomonocytic leukemia treated with sunitinib malate.

II. Determine the duration of response in patients treated with this drug. III. Determine
the overall survival of patients treated with this drug. IV. Determine the progression-free
survival of patients treated with this drug. V. Determine the time to disease progression in
patients treated with this drug.

VI. Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 4 weeks
in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 3-4 weeks and then monthly

Inclusion Criteria


- Myelodysplastic syndromes (MDS) meeting 1 of the following criteria: Intermediate-2
disease, high-risk disease (International Prognostic Scoring System [IPSS] score >=

- Chronic myelomonocytic leukemia (CMML): WBC > 12,000/mm^3, Intermediate-2 disease
with WBC =< 12,000/mm^3, high-risk disease (IPSS score >= 1.5) with WBC =<

- Patients with insufficient or inadequate metaphases for cytogenetic analysis are
eligible provided bone marrow blasts are > 10% and/or 2-3 cytopenias are present

- No known brain metastases

- Life expectancy > 12 weeks

- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%

- Calcium =< 3.0 mmol/L

- Bilirubin normal

- AST and ALT =< 2.5 times upper limit of normal (ULN)

- Creatinine normal OR creatinine clearance >= 60 mL/min

- No history of significant electrocardiogram abnormalities including, but not limited
to, the following: ventricular arrhythmias (ventricular tachycardia, ventricular
fibrillation >= 3 beats in a row); QTc prolongation (i.e., QTc interval >= 500 msec)

- No history of allergic reaction to compounds of similar chemical or biological
composition to sunitinib malate

- No NYHA class III-IV congestive heart failure

- Patients with a history of NYHA class II congestive heart failure who are
asymptomatic on treatment are eligible

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within
the past 28 days

- No serious cardiovascular disease within the past 12 months, including the following:
cerebrovascular accident or transient ischemic attack, myocardial infarction, cardiac
arrhythmia, stable or unstable angina, symptomatic congestive heart failure, coronary
or peripheral artery bypass graft or stenting

- No pulmonary embolism within the past 12 months

- No uncontrolled hypertension, defined as systolic blood pressure (BP) >= 140 mm Hg or
diastolic BP >= 90 mm Hg

- No condition that impairs the ability to swallow and retain sunitinib malate tablets,
including the following: gastrointestinal tract disease resulting in an inability to
take oral medication, requirement for IV alimentation, prior surgical procedures
affecting absorption, active peptic ulcer disease

- No serious or nonhealing wound, ulcer, or bone fracture

- No uncontrolled pre-existing thyroid abnormality

- No concurrent uncontrolled illness, including ongoing or active infection

- No psychiatric illness or social situation that would preclude study participation

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception

- At least 4 weeks since prior major surgery

- Prior central thoracic radiotherapy that included the heart in the radiotherapy port
allowed provided New York Heart Association (NYHA) congestive heart failure =< class

- Prior anthracycline exposure allowed provided NYHA congestive heart failure =< class

- No other prior therapy for MDS or CMML except for epoetin alfa, darbepoetin alfa,
filgrastim (G-CSF), or sargramostim (GM-CSF)

- At least 2 weeks since prior epoetin alfa

- At least 4 weeks since prior darbepoetin alfa

- No other prior antiangiogenic agents including, but not limited to, the following:
bevacizumab, sorafenib tosylate, pazopanib hydrochloride, AZD2171, vatalanib, VEGF

- More than 7 days since prior and no concurrent potent CYP3A4 inhibitors, including
the following: azole antifungals (e.g., ketoconazole or itraconazole), HIV protease
inhibitors (e.g., indinavir sulfate, saquinavir mesylate, ritonavir, atazanavir, or
nelfinavir mesylate), verapamil, clarithromycin, erythromycin, diltiazem
hydrochloride, delavirdine

- More than 12 days since prior and no concurrent potent CYP3A4 inducers, including the
following: Rifampin, Rifabutin, Carbamazepine, Phenobarbital, Phenytoin, Hypericum
perforatum (St. John's wort), Efavirenz, Tipranavir

- No concurrent birth control patch, oral birth control pills, depot, or injectable
birth control methods

- No concurrent therapeutic coumarin-derivative anticoagulants (e.g., warfarin)

- Low dose (=< 2 mg) warfarin for prophylaxis of thrombosis allowed

- Low molecular weight heparin allowed provided INR =< 1.5

- No concurrent agents with proarrhythmic potential, including the following:
Terfenadine, Quinidine, Procainamide, Disopyramide, Sotalol, Probucol, Bepridil,
Haloperidol, Risperidone, Indapamide, Flecainide acetate

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent investigational agents

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (complete response, partial response, or hematologic improvement) defined by the International Working Group Criteria

Outcome Time Frame:

Up to 6 years

Safety Issue:


Principal Investigator

Karen Yee

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network-Princess Margaret Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

February 2007

Completion Date:

Related Keywords:

  • Chronic Myelomonocytic Leukemia
  • de Novo Myelodysplastic Syndromes
  • Myelodysplastic Syndromes
  • Secondary Myelodysplastic Syndromes
  • Leukemia
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute



Roswell Park Cancer InstituteBuffalo, New York  14263