Trial Outcomes & Findings for Trial of Sunitinib for Refractory Malignant Ascites (NCT NCT00796861)
NCT ID: NCT00796861
Last Updated: 2017-12-20
Results Overview
A response will be considered to be 3 cm or more decrease in abdominal girth, or decreased frequency of paracentesis (compared to pre-enrollment). Toxicity monitoring would be the same as that is the expanded access Sutent trial.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
An average of every 6 weeks
Results posted on
2017-12-20
Participant Flow
Participant milestones
| Measure |
Single Arm
Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx
Sunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Single Arm
Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx
Sunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Trial of Sunitinib for Refractory Malignant Ascites
Baseline characteristics by cohort
| Measure |
Single Arm
n=4 Participants
Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx
Sunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: An average of every 6 weeksPopulation: No analyses were performed as none of the subjects made it through a full cycle.
A response will be considered to be 3 cm or more decrease in abdominal girth, or decreased frequency of paracentesis (compared to pre-enrollment). Toxicity monitoring would be the same as that is the expanded access Sutent trial.
Outcome measures
Outcome data not reported
Adverse Events
Single Arm
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Arm
n=3 participants at risk
Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx
Sunitinib: Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).
|
|---|---|
|
General disorders
Weakness
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Nausea
|
66.7%
2/3 • Number of events 4
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Vomiting
|
66.7%
2/3 • Number of events 3
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
Skin and subcutaneous tissue disorders
Erythematous macular erruption
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Insomnia
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Tremors
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Feeling cold
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
Skin and subcutaneous tissue disorders
Stenotrophomas (3+) lesion right thigh
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcers
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
Renal and urinary disorders
Increased creatinine level
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
Hepatobiliary disorders
Increased aspartate aminotransferase (AST) level
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
UTI
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
Skin and subcutaneous tissue disorders
Labial exoriation
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Anorexia
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Hyponatremia
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Hyperkalemia
|
66.7%
2/3 • Number of events 2
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Hypocalcemia
|
66.7%
2/3 • Number of events 2
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Decreased Albumin level
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Hypoglycemia
|
66.7%
2/3 • Number of events 2
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Increased Hemoglobin count
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Decreased white blood cell count
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
General disorders
Decreased platelet count
|
33.3%
1/3 • Number of events 1
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
Skin and subcutaneous tissue disorders
Ulcer
|
33.3%
1/3 • Number of events 4
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
|
Skin and subcutaneous tissue disorders
Fissures
|
33.3%
1/3 • Number of events 2
1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60