Trial Outcomes & Findings for Evaluation of Patients With Bulky GIST Using Sunitinib (NCT NCT01054911)
NCT ID: NCT01054911
Last Updated: 2016-09-22
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
6 months
Results posted on
2016-09-22
Participant Flow
Participant milestones
| Measure |
Sunitinib Pill
Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.
Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.
Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Patients With Bulky GIST Using Sunitinib
Baseline characteristics by cohort
| Measure |
Sunitinib Pill
n=5 Participants
Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.
Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.
Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Neoadjuvant Therapy Plus Surgery
n=4 Participants
Patients received oral therapy for up to 12 weeks and re-evaluated for response. Favorable tumor reduction resulted surgical extirpation typically with less morbid operative intervention.
|
Neoadjuvant Therapy no Surgery
n=1 Participants
Patients received oral therapy for up to 12 weeks. Reassessment demonstrated response, but no surgical intervention
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|---|---|---|
|
Number of Participants With Adverse Events
|
4 participants
|
1 participants
|
SECONDARY outcome
Timeframe: FDG PET scan at baseline and Week 2, CT scan at baseline and Week 12Population: Data were not collected.
Positron electron emission tomography (PET) using 18F-fluorodeoxyglucose (FDG) and computed tomography (CT) will be used. None of the participants were analyzed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: MRI at baseline, Week 2 and Week 6Population: Data were not collected
The Response Evaluation Criteria in Solid Tumors (RECIST) criteria may be insensitive in assessing GIST so the Choi criteria will be used. The Choi criteria accounts for morphologic tumor changes and biologic alterations. Diffusion-weighted magnetic resonance imaging (MRI) and dynamic contrast magnetic resonance will be used to find the vascular permeability and apparent diffusion coefficient 9ACD) at baseline, Week 2 and Week 6. Weeks 2 and 6 values will be compared to the baseline values using paired t tests.
Outcome measures
Outcome data not reported
Adverse Events
Sunitinib Pill
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sunitinib Pill
n=5 participants at risk
Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.
Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.
Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16.
|
|---|---|
|
Blood and lymphatic system disorders
neutropenia
|
40.0%
2/5 • Number of events 2 • February 2010 to March 2012
|
|
General disorders
fatigue
|
60.0%
3/5 • Number of events 3 • February 2010 to March 2012
|
|
Gastrointestinal disorders
diarrhea
|
60.0%
3/5 • Number of events 4 • February 2010 to March 2012
|
|
Gastrointestinal disorders
altered taste
|
40.0%
2/5 • Number of events 2 • February 2010 to March 2012
|
|
Gastrointestinal disorders
mucositis
|
40.0%
2/5 • Number of events 2 • February 2010 to March 2012
|
|
Nervous system disorders
hand and foot syndrome
|
40.0%
2/5 • Number of events 2 • February 2010 to March 2012
|
|
Skin and subcutaneous tissue disorders
hyperpigmentation
|
40.0%
2/5 • Number of events 2 • February 2010 to March 2012
|
|
Gastrointestinal disorders
dysphagia
|
20.0%
1/5 • Number of events 1 • February 2010 to March 2012
|
|
Gastrointestinal disorders
constipation
|
20.0%
1/5 • Number of events 1 • February 2010 to March 2012
|
|
Blood and lymphatic system disorders
hyponatremia
|
20.0%
1/5 • Number of events 1 • February 2010 to March 2012
|
|
Gastrointestinal disorders
gastrointestinal reflux disease
|
40.0%
2/5 • Number of events 2 • February 2010 to March 2012
|
|
Cardiac disorders
hypertension
|
20.0%
1/5 • Number of events 1 • February 2010 to March 2012
|
|
Gastrointestinal disorders
vomiting
|
20.0%
1/5 • Number of events 1 • February 2010 to March 2012
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
20.0%
1/5 • Number of events 1 • February 2010 to March 2012
|
|
Musculoskeletal and connective tissue disorders
swelling
|
20.0%
1/5 • Number of events 1 • February 2010 to March 2012
|
|
Gastrointestinal disorders
nausea
|
20.0%
1/5 • Number of events 1 • February 2010 to March 2012
|
Additional Information
Dr. James Posey, MD
University of Alabama in Birmingham, Comprehensive Cancer Center
Phone: 205-934-0916
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place