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Sunitinib in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

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ClinicalTrials.gov Identifier: NCT00451048
Recruitment Status : Completed
First Posted : March 22, 2007
Results First Posted : September 1, 2014
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndromes
Myelodysplastic Syndromes
Secondary Myelodysplastic Syndromes
Intervention Drug: sunitinib malate
Enrollment 10

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I
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Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.

sunitinib malate: Given orally

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Arm I
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Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.

sunitinib malate: Given orally

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
69
(62 to 87)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  20.0%
>=65 years
8
  80.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
3
  30.0%
Male
7
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
United States 1
Canada 9
1.Primary Outcome
Title Overall Response Rate (Complete Response, Partial Response, or Hematologic Improvement) Defined by the International Working Group Criteria
Hide Description [Not Specified]
Time Frame Up to 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
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Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.

sunitinib malate: Given orally

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: percentage of participants
10
2.Secondary Outcome
Title Number Participants With Complete, Partial or Hematologic Improvement Response
Hide Description Assessed by achievement of Complete Response (CR), Partial Response (PR) or Hematologic Improvement (HI)
Time Frame Up to 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
No patient achieved CR, PR or HI as response.
Arm/Group Title Arm I
Hide Arm/Group Description:

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

sunitinib malate: Given orally

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
0
3.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame At 6 months and 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
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Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.

sunitinib malate: Given orally

Overall Number of Participants Analyzed 5
Median (95% Confidence Interval)
Unit of Measure: months
13.9 [1] 
(9.7 to NA)
[1]
95% confidence - 9.7 months to not reached
4.Secondary Outcome
Title Progression-free Survival
Hide Description [Not Specified]
Time Frame At 6 months and 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Arm I
Hide Arm/Group Description:

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

sunitinib malate: Given orally

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Time to Progression
Hide Description [Not Specified]
Time Frame At 6 months and 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Date were not collected
Arm/Group Title Arm I
Hide Arm/Group Description:

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

sunitinib malate: Given orally

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Highest Severity of Observed Adverse Events Assessed by Common Terminology Criteria or Adverse Events Version 3.0 (CTCAE v3.0)
Hide Description [Not Specified]
Time Frame Up to 6 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

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

sunitinib malate: Given orally

Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: highest grade of adverse event reported
4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I
Hide Arm/Group Description

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

sunitinib malate: Given orally

All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%)
Total   4/10 (40.00%) 
Blood and lymphatic system disorders   
Febrile neutropenia   3/10 (30.00%) 
Gastrointestinal disorders   
Small intestinal obstruction   1/10 (10.00%) 
Anal pain   1/10 (10.00%) 
Gastrointestinal disorders - Other, specify   1/10 (10.00%) 
General disorders   
Fever   1/10 (10.00%) 
Pain   1/10 (10.00%) 
Infections and infestations   
Encephalitis infection   1/10 (10.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I
Affected / at Risk (%)
Total   10/10 (100.00%) 
Blood and lymphatic system disorders   
Anemia   10/10 (100.00%) 
General disorders   
Fatigue   10/10 (100.00%) 
Investigations   
Neutrophil count decreased   9/10 (90.00%) 
Platelet count decreased   9/10 (90.00%) 
Lymphocyte count decreased   8/10 (80.00%) 
White blood cell decreased   8/10 (80.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea   9/10 (90.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Karen Yee
Organization: Princess Margaret Hospital
Phone: 416-946-4495
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00451048     History of Changes
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 Submitted: March 20, 2007
First Posted: March 22, 2007
Results First Submitted: August 20, 2014
Results First Posted: September 1, 2014
Last Update Posted: September 3, 2018