Trial Outcomes & Findings for Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma (NCT NCT00589784)
NCT ID: NCT00589784
Last Updated: 2016-01-25
Results Overview
Determine the overall objective response
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
1.5 years
Results posted on
2016-01-25
Participant Flow
Participant milestones
| Measure |
Aggressive Memingioma
Patients with Aggressive Memingioma
|
Exploratory Cohort
Patients with WHO grade I meningioma, HPC and hemangioblastoma
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
14
|
|
Overall Study
COMPLETED
|
35
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
10
|
Reasons for withdrawal
| Measure |
Aggressive Memingioma
Patients with Aggressive Memingioma
|
Exploratory Cohort
Patients with WHO grade I meningioma, HPC and hemangioblastoma
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
|
Overall Study
Patient inevaluable
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
4
|
Baseline Characteristics
Phase II Trial of Sunitinib (SU011248) in Patients With Recurrent or Inoperable Meningioma
Baseline characteristics by cohort
| Measure |
Aggressive Memingioma
n=36 Participants
Patients with Aggressive Memingioma
|
Exploratory Cohort
n=13 Participants
Patients with WHO grade I meningioma, HPC and hemangioblastoma
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Median Age
|
61 years
n=5 Participants
|
48 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1.5 yearsDetermine the overall objective response
Outcome measures
| Measure |
Aggressive Memingioma
n=35 Participants
Patients with Aggressive Memingioma
|
Exploratory Cohort
n=4 Participants
Patients with WHO grade I meningioma, HPC and hemangioblastoma
|
|---|---|---|
|
Overall Objective Response
Complete Response
|
1 participants
|
0 participants
|
|
Overall Objective Response
Partial Response
|
1 participants
|
0 participants
|
|
Overall Objective Response
Progression of Disease
|
8 participants
|
4 participants
|
|
Overall Objective Response
Stable Disease
|
25 participants
|
0 participants
|
Adverse Events
All Patients
Serious events: 27 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=50 participants at risk
All patients treated with Sunitinib (SU011248)
|
|---|---|
|
Nervous system disorders
CNS Hemorrhage
|
8.0%
4/50 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Thrombic Microangiopathy
|
4.0%
2/50 • Number of events 2
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.0%
4/50 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.0%
2/50 • Number of events 2
|
|
General disorders
Fatigue
|
18.0%
9/50 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Thrombocytopenia
|
12.0%
6/50 • Number of events 6
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.0%
5/50 • Number of events 5
|
|
Blood and lymphatic system disorders
Lueukopenia
|
6.0%
3/50 • Number of events 3
|
|
Cardiac disorders
Hypertension
|
8.0%
4/50 • Number of events 4
|
|
General disorders
Headache
|
8.0%
4/50 • Number of events 4
|
|
Blood and lymphatic system disorders
ALT
|
4.0%
2/50 • Number of events 2
|
|
Blood and lymphatic system disorders
AST
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Dehydration
|
4.0%
2/50 • Number of events 2
|
|
General disorders
Pain
|
4.0%
2/50 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.0%
2/50 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash, Hand-Foot Reaction
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • Number of events 2
|
|
Gastrointestinal disorders
Pancreatitis
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Confusion
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Creatinine
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Prolonged QTc Interval
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Right Ventricular Enlargement
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Thrombosis/ Embolism
|
2.0%
1/50 • Number of events 1
|
|
Renal and urinary disorders
Hyperuricemia
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
2.0%
1/50 • Number of events 1
|
Other adverse events
| Measure |
All Patients
n=50 participants at risk
All patients treated with Sunitinib (SU011248)
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
62.0%
31/50 • Number of events 31
|
|
General disorders
Fatigue
|
58.0%
29/50 • Number of events 29
|
|
Respiratory, thoracic and mediastinal disorders
Thrombocytopenia
|
46.0%
23/50 • Number of events 23
|
|
Gastrointestinal disorders
Diarrhea
|
44.0%
22/50 • Number of events 22
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
38.0%
19/50 • Number of events 19
|
|
Blood and lymphatic system disorders
AST
|
38.0%
19/50 • Number of events 19
|
|
Blood and lymphatic system disorders
ALT
|
34.0%
17/50 • Number of events 17
|
|
Gastrointestinal disorders
Nausea
|
34.0%
17/50 • Number of events 17
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
32.0%
16/50 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Rash, Hand-Foot Reaction
|
32.0%
16/50 • Number of events 16
|
|
General disorders
Mucositis
|
26.0%
13/50 • Number of events 13
|
|
Blood and lymphatic system disorders
Neutropenia
|
26.0%
13/50 • Number of events 13
|
|
General disorders
Dysgeusia
|
26.0%
13/50 • Number of events 13
|
|
General disorders
Headache
|
24.0%
12/50 • Number of events 12
|
|
Gastrointestinal disorders
Vomiting
|
24.0%
12/50 • Number of events 12
|
|
Cardiac disorders
Hypertension
|
22.0%
11/50 • Number of events 11
|
Additional Information
Dr. Thomas Kaley
Memorial Sloan Kettering Cancer Center
Phone: 212-639-5122
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place