Trial Outcomes & Findings for Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas (NCT NCT00474994)

Last Updated: 2016-01-20

Results Overview

as assessed by RECIST criteria

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

53 participants

Primary outcome timeframe

2 years

Results posted on

2016-01-20

Participant milestones
Measure	Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Overall Study STARTED	53
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	5

Reasons for withdrawal
Measure	Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Overall Study Patient Not treated	1
Overall Study Patient evaluable for toxicity only	3
Overall Study Patient found to be ineligible	1

Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent Sarcomas

Baseline characteristics by cohort
Measure	Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas n=53 Participants Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants

Timeframe: 2 years

as assessed by RECIST criteria

Outcome measures
Measure	Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas n=48 Participants Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Overall Objective Response Partial Response (PR)	1 participants
Overall Objective Response Stable Disease (SD)	21 participants
Overall Objective Response Progression of Disease (POD)	26 participants

Serious events: 9 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events
Measure	Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas n=53 participants at risk Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
General disorders Death not associated with CTCAE term- Death NOS	1.9% 1/53 • Number of events 1
General disorders Death not associated with CTCAE term-Disease progression NOS	3.8% 2/53 • Number of events 2
Nervous system disorders Dizziness	1.9% 1/53 • Number of events 1
Blood and lymphatic system disorders Hemoglobin	1.9% 1/53 • Number of events 2
General disorders Pain - Abdomen NOS	1.9% 1/53 • Number of events 1
Blood and lymphatic system disorders Platelets	1.9% 1/53 • Number of events 1
Gastrointestinal disorders Pneumothorax	1.9% 1/53 • Number of events 1
Nervous system disorders Seizure	1.9% 1/53 • Number of events 2
Respiratory, thoracic and mediastinal disorders Thrombosis/thrombus/embolism	1.9% 1/53 • Number of events 1
Gastrointestinal disorders Ulcer, Duodenum	3.8% 2/53 • Number of events 3

Other adverse events
Measure	Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas n=53 participants at risk Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
Blood and lymphatic system disorders AST, SGOT	5.7% 3/53 • Number of events 3
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	7.5% 4/53 • Number of events 4
Gastrointestinal disorders Diarrhea	13.2% 7/53 • Number of events 7
General disorders Fatigue (asthenia, lethargy, malaise)	11.3% 6/53 • Number of events 6
Gastrointestinal disorders Gastrointestinal, other	5.7% 3/53 • Number of events 3
Blood and lymphatic system disorders Hemoglobin	9.4% 5/53 • Number of events 5
Cardiac disorders Hypertension	17.0% 9/53 • Number of events 9
Blood and lymphatic system disorders Leukocytes (total WBC)	26.4% 14/53 • Number of events 14
Blood and lymphatic system disorders Lymphopenia	5.7% 3/53 • Number of events 3
General disorders Mucositis (Clincal exam)- Oral cavity	13.2% 7/53 • Number of events 7
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	28.3% 15/53 • Number of events 15
Blood and lymphatic system disorders Platelets	13.2% 7/53 • Number of events 7
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	13.2% 7/53 • Number of events 7

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