Trial Outcomes & Findings for Sunitinib in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia (NCT NCT00451048)

NCT ID: NCT00451048

Last Updated: 2018-09-04

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: Up to 6 years
• Results posted on: 2018-09-04

Participant Flow

Participant milestones

Measure	Arm I Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown. sunitinib malate: Given orally
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sunitinib in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia

Baseline characteristics by cohort

Measure	Arm I n=10 Participants Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown. sunitinib malate: Given orally
Age, Continuous	69 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants
Region of Enrollment Canada	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 years

Outcome measures

Measure	Arm I n=10 Participants Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown. sunitinib malate: Given orally
Overall Response Rate (Complete Response, Partial Response, or Hematologic Improvement) Defined by the International Working Group Criteria	10 percentage of participants

SECONDARY outcome

Timeframe: Up to 6 years

Population: No patient achieved CR, PR or HI as response.

Assessed by achievement of Complete Response (CR), Partial Response (PR) or Hematologic Improvement (HI)

Outcome measures

Measure	Arm I n=10 Participants Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown. sunitinib malate: Given orally
Number Participants With Complete, Partial or Hematologic Improvement Response	0 participants

SECONDARY outcome

Timeframe: At 6 months and 1 year

Outcome measures

Measure	Arm I n=5 Participants Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown. sunitinib malate: Given orally
Overall Survival	13.9 months Interval 9.7 to 95% confidence - 9.7 months to not reached

SECONDARY outcome

Timeframe: At 6 months and 1 year

Population: Data were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 6 months and 1 year

Population: Date were not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 years

Outcome measures

Measure	Arm I n=10 Participants Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown. sunitinib malate: Given orally
Highest Severity of Observed Adverse Events Assessed by Common Terminology Criteria or Adverse Events Version 3.0 (CTCAE v3.0)	4 highest grade of adverse event reported

Adverse Events

Arm I

Serious events: 4 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I n=10 participants at risk Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown. sunitinib malate: Given orally
Blood and lymphatic system disorders Febrile neutropenia	30.0% 3/10
Gastrointestinal disorders Small intestinal obstruction	10.0% 1/10
General disorders Fever	10.0% 1/10
General disorders Pain	10.0% 1/10
Gastrointestinal disorders Anal pain	10.0% 1/10
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	10.0% 1/10
Infections and infestations Encephalitis infection	10.0% 1/10

Other adverse events

Measure	Arm I n=10 participants at risk Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown. sunitinib malate: Given orally
Blood and lymphatic system disorders Anemia	100.0% 10/10
General disorders Fatigue	100.0% 10/10
Respiratory, thoracic and mediastinal disorders Dyspnea	90.0% 9/10
Investigations Neutrophil count decreased	90.0% 9/10
Investigations Platelet count decreased	90.0% 9/10
Investigations Lymphocyte count decreased	80.0% 8/10
Investigations White blood cell decreased	80.0% 8/10

Additional Information

Dr. Karen Yee

Princess Margaret Hospital

Phone: 416-946-4495

Email: karen.yee2@uhn.on.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60