Sunitinib in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

NCT00451048 | Completed Phase 2 Results DMC

• 4 other identifiers: NCI-2009-00211PHL-063CDR0000535656N01CM62203
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 4

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.

Conditions

Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Myelodysplastic Syndromes; Secondary Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (Complete Response, Partial Response, or Hematologic Improvement) Defined by the International Working Group Criteria

  Up to 6 years

Secondary Outcomes (5)

• Number Participants With Complete, Partial or Hematologic Improvement Response

  Up to 6 years

• Overall Survival

  At 6 months and 1 year

• Progression-free Survival

  At 6 months and 1 year

• Time to Progression

  At 6 months and 1 year

• Highest Severity of Observed Adverse Events Assessed by Common Terminology Criteria or Adverse Events Version 3.0 (CTCAE v3.0)

  Up to 6 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients will receive sunitinib malate (SU11248) by mouth once a day. Treatment may continue for as long as benefit is shown.

Drug: sunitinib malate

Interventions

sunitinib malate DRUG

Given orally

Also known as: SU11248, sunitinib, Sutent

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Odette Cancer Centre- Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Leukemia, Myelomonocytic, Chronic; Myelodysplastic Syndromes

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Karen Yee
• Organization: Princess Margaret Hospital

karen.yee2@uhn.on.ca

416-946-4495

Study Officials

• Karen Yee

  University Health Network-Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2007
• First Posted: March 22, 2007
• Study Start: February 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2012
• Last Updated: September 4, 2018
• Results First Posted: September 1, 2014

Record last verified: 2018-07

Locations

CA (3); US (1)