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Sunitinib in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00451048
Recruitment Status : Completed
First Posted : March 22, 2007
Results First Posted : September 1, 2014
Last Update Posted : September 4, 2018
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase II trial is studying how well sunitinib works in treating patients with myelodysplastic syndromes or chronic myelomonocytic leukemia. Sunitinib may stop the growth of abnormal cells by blocking some of the enzymes needed for cell growth.

Condition or disease Intervention/treatment Phase
Chronic Myelomonocytic Leukemia de Novo Myelodysplastic Syndromes Myelodysplastic Syndromes Secondary Myelodysplastic Syndromes Drug: sunitinib malate Phase 2

Detailed Description:


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 thereafter.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Sunitinib Malate (Sutent®; SU11248) in Patients With Intermediate-2 or High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Study Start Date : February 2007
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2012

Arm Intervention/treatment
Experimental: Arm I
Patients will receive sunitinib malate (SU11248) by mouth once a day. Treatment may continue for as long as benefit is shown.
Drug: sunitinib malate
Given orally
Other Names:
  • SU11248
  • sunitinib
  • Sutent

Primary Outcome Measures :
  1. Overall Response Rate (Complete Response, Partial Response, or Hematologic Improvement) Defined by the International Working Group Criteria [ Time Frame: Up to 6 years ]

Secondary Outcome Measures :
  1. Number Participants With Complete, Partial or Hematologic Improvement Response [ Time Frame: Up to 6 years ]
    Assessed by achievement of Complete Response (CR), Partial Response (PR) or Hematologic Improvement (HI)

  2. Overall Survival [ Time Frame: At 6 months and 1 year ]
  3. Progression-free Survival [ Time Frame: At 6 months and 1 year ]
  4. Time to Progression [ Time Frame: At 6 months and 1 year ]
  5. Highest Severity of Observed Adverse Events Assessed by Common Terminology Criteria or Adverse Events Version 3.0 (CTCAE v3.0) [ Time Frame: Up to 6 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • MDS syndromes meeting 1 of the following: Intermediate-2 disease, high-risk disease (IPSS score>=1.5)
  • CMML: WBC>12,000/mm^3, Intermediate-2 disease with WBC=<12,000/mm^3, high-risk disease (IPSS score>=1.5) with WBC=<12,000/mm^3
  • Patients with insufficient/inadequate metaphases for cytogenetic analysis are eligible if bone marrow blasts are >10% and/or 2-3 cytopenias are present
  • No known brain metastases
  • Life expectancy>12 weeks
  • ECOG PS 0-2/Karnofsky PS 60-100%
  • Calcium=<3.0 mmol/L
  • Bilirubin normal
  • AST and ALT=<2.5 times upper limit of normal
  • Creatinine normal/creatinine clearance>=60 mL/min

Exclusion Criteria:

  • No history of significant ECG abnormalities including but not limited to: ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation>=3 beats in a row); QTc prolongation (i.e.QTc interval>=500msec)
  • No history of allergic reaction to compounds of similar chemical/biological composition to sunitinib malate
  • No NYHA class III-IV congestive heart failure
  • Patients with history of NYHA class II congestive heart failure who are asymptomatic on treatment are eligible
  • No abdominal fistula/G perforation/intraabdominal abscess within past 28 days
  • No serious cardiovascular disease within past 12 months including: 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 past 12 months
  • No uncontrolled hypertension (systolic BP>=140 mmHg/diastolic BP>=90 mmHg)
  • No condition impairing ability to swallow/retain sunitinib malate tablets including: GI tract disease resulting in inability to take oral medication, requirement for IV alimentation, prior surgical procedures affecting absorption, active peptic ulcer disease
  • No serious/nonhealing wound, ulcer, or bone fracture
  • No uncontrolled pre-existing thyroid abnormality
  • No concurrent uncontrolled illness including ongoing/active infection
  • No psychiatric illness/social situation that would preclude study participation
  • Not pregnant/nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • 4 weeks since prior major surgery
  • Prior central thoracic radiotherapy that included heart in radiotherapy port allowed provided NYHA congestive heart failure=<class II
  • Prior anthracycline exposure allowed provided NYHA congestive heart failure=<class II
  • No other prior therapy for MDS/CMML except epoetin alfa, darbepoetin alfa, filgrastim or sargramostim
  • 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: bevacizumab, sorafenib tosylate, pazopanib hydrochloride, AZD2171, vatalanib, VEGF Trap
  • More than 7 days since prior and no concurrent potent CYP3A4 inhibitors
  • More than 12 days since prior and no concurrent potent CYP3A4 inducers including: Rifampin, Rifabutin, Carbamazepine, Phenobarbital, Phenytoin, Hypericum perforatum, Efavirenz, Tipranavir
  • No concurrent birth control patch/oral birth control pills/depot/injectable birth control methods
  • No concurrent therapeutic coumarin-derivative anticoagulants
  • Low dose(=<2mg) warfarin for prophylaxis of thrombosis allowed
  • Low molecular weight heparin allowed if INR=<1.5
  • No concurrent agents with proarrhythmic potential including: 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00451048

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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Canada, Ontario
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Karen Yee University Health Network-Princess Margaret Hospital
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00451048    
Other Study ID Numbers: NCI-2009-00211
PHL-063 ( Other Grant/Funding Number: N01CM62203 )
CDR0000535656 ( Other Grant/Funding Number: N01CM62203 )
N01CM62203 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2007    Key Record Dates
Results First Posted: September 1, 2014
Last Update Posted: September 4, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action