Trial Outcomes & Findings for Sunitinib in Treating Patients With Idiopathic Myelofibrosis (NCT NCT00387426)
NCT ID: NCT00387426
Last Updated: 2014-05-28
Results Overview
Participant response assessed after two cycles of therapy according to categories: 1) complete response, 2) partial response, 3) clinical improvement, 4) stable disease 5) progressive disease, 6) early death from malignant disease, 7) early death from toxicity, 8) early death because of other cause, or 9) unknown (not assessable, insufficient data).
TERMINATED
PHASE2
14 participants
After two 6-week treatment courses (12 weeks)
2014-05-28
Participant Flow
Recruitment Period: September 14, 2006 to December 17, 2007. All recruitment done at UT MD Anderson Cancer Center.
Participant milestones
| Measure |
Sunitinib
37.5 mg orally daily for 6-week cycle
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Sunitinib
37.5 mg orally daily for 6-week cycle
|
|---|---|
|
Overall Study
Lack of Response
|
7
|
|
Overall Study
Toxicities
|
4
|
|
Overall Study
Disease Progression
|
3
|
Baseline Characteristics
Sunitinib in Treating Patients With Idiopathic Myelofibrosis
Baseline characteristics by cohort
| Measure |
Sunitinib
n=14 Participants
37.5 mg orally daily for 6-week cycle
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After two 6-week treatment courses (12 weeks)Population: All participants assessed for response.
Participant response assessed after two cycles of therapy according to categories: 1) complete response, 2) partial response, 3) clinical improvement, 4) stable disease 5) progressive disease, 6) early death from malignant disease, 7) early death from toxicity, 8) early death because of other cause, or 9) unknown (not assessable, insufficient data).
Outcome measures
| Measure |
Sunitinib
n=14 Participants
37.5 mg orally daily for 6-week cycle
|
|---|---|
|
Number of Participants With Objective Clinical Response to Sunitinib Therapy
|
1 participants
|
Adverse Events
Sunitinib
Serious adverse events
| Measure |
Sunitinib
n=14 participants at risk
37.5 mg orally daily for 6-week cycle
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
7.1%
1/14 • Number of events 2 • 2 years
|
|
Blood and lymphatic system disorders
Optic Disc Edema
|
7.1%
1/14 • Number of events 1 • 2 years
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14 • Number of events 1 • 2 years
|
|
General disorders
Pain
|
7.1%
1/14 • Number of events 4 • 2 years
|
|
Blood and lymphatic system disorders
Thrombosis Embolism
|
7.1%
1/14 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Hemorrhage
|
14.3%
2/14 • Number of events 2 • 2 years
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
7.1%
1/14 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Sunitinib
n=14 participants at risk
37.5 mg orally daily for 6-week cycle
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
35.7%
5/14 • Number of events 5 • 2 years
|
|
General disorders
Fatigue
|
21.4%
3/14 • Number of events 3 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
4/14 • Number of events 4 • 2 years
|
|
Cardiac disorders
High Blood Pressure
|
57.1%
8/14 • Number of events 8 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
42.9%
6/14 • Number of events 6 • 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
28.6%
4/14 • Number of events 4 • 2 years
|
|
Gastrointestinal disorders
Mucositis
|
7.1%
1/14 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Elevated Liver Function Tests
|
14.3%
2/14 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
64.3%
9/14 • Number of events 9 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
7.1%
1/14 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
85.7%
12/14 • Number of events 12 • 2 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
2/14 • Number of events 2 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
7.1%
1/14 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Number of events 1 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60