Trial Outcomes & Findings for Fosaprepitant for N/V With High-dose Interleukin-2 for Metastatic Melanoma and Renal Cell Carcinoma (NCT NCT01874119)
NCT ID: NCT01874119
Last Updated: 2018-06-07
Results Overview
No vomiting from the initiation of through 48 hours following the final dose of HD IL-2
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
From the initiation of through 48 hours following the final dose of Interleukin-2
Results posted on
2018-06-07
Participant Flow
Participant milestones
| Measure |
Fosaprepitant First, Then Placebo
Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission
Placebo: During placebo admission, intravenous 0.9% saline every 48 hours during 6-day hospital admission
|
Placebo First, Then Fosaprepitant
Placebo: During placebo admission, intravenous 0.9% saline every 48 hours during 6-day hospital admission
Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission
|
|---|---|---|
|
First Intervention (6 Days)
STARTED
|
8
|
5
|
|
First Intervention (6 Days)
COMPLETED
|
7
|
5
|
|
First Intervention (6 Days)
NOT COMPLETED
|
1
|
0
|
|
Washout (7 Days)
STARTED
|
7
|
5
|
|
Washout (7 Days)
COMPLETED
|
4
|
3
|
|
Washout (7 Days)
NOT COMPLETED
|
3
|
2
|
|
Second Intervention (6 Days)
STARTED
|
4
|
3
|
|
Second Intervention (6 Days)
COMPLETED
|
4
|
3
|
|
Second Intervention (6 Days)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fosaprepitant for N/V With High-dose Interleukin-2 for Metastatic Melanoma and Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Study Participants Completing All Cycles
n=7 Participants
Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission
Placebo: intravenous 0.9% saline every 48 hours during 6-day hospital admission
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the initiation of through 48 hours following the final dose of Interleukin-2No vomiting from the initiation of through 48 hours following the final dose of HD IL-2
Outcome measures
| Measure |
Fosaprepitant
n=7 Participants
During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission
Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission
|
Placebo
n=7 Participants
During placebo admission, intravenous 0.9% saline every 48 hours during 6-day hospital admission
Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission
|
|---|---|---|
|
Number of Patients With Complete Response During Inpatient Admission
|
1 Participants
|
0 Participants
|
Adverse Events
Fosaprepitant
Serious events: 3 serious events
Other events: 11 other events
Deaths: 2 deaths
Placebo
Serious events: 4 serious events
Other events: 9 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Fosaprepitant
n=11 participants at risk
During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission
Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission
|
Placebo
n=9 participants at risk
During placebo admission, intravenous 0.9% saline every 48 hours during 6-day hospital admission
Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission
|
|---|---|---|
|
Gastrointestinal disorders
Upper GI hemorrhage
|
9.1%
1/11 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
0.00%
0/9 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Nervous system disorders
Other - Uncal herniation
|
9.1%
1/11 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
0.00%
0/9 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Infections and infestations
Sepsis
|
0.00%
0/11 • From the initiation of through 48 hours following the final dose of HD IL-2
|
11.1%
1/9 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Immune system disorders
Autoimmune disorder - Myocarditis
|
0.00%
0/11 • From the initiation of through 48 hours following the final dose of HD IL-2
|
11.1%
1/9 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • From the initiation of through 48 hours following the final dose of HD IL-2
|
11.1%
1/9 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Cardiac disorders
Bradycardia
|
9.1%
1/11 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
0.00%
0/9 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Cardiac disorders
Cardiac arrest
|
9.1%
1/11 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
33.3%
3/9 • Number of events 3 • From the initiation of through 48 hours following the final dose of HD IL-2
|
Other adverse events
| Measure |
Fosaprepitant
n=11 participants at risk
During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission
Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission
|
Placebo
n=9 participants at risk
During placebo admission, intravenous 0.9% saline every 48 hours during 6-day hospital admission
Fosaprepitant: During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
18.2%
2/11 • Number of events 2 • From the initiation of through 48 hours following the final dose of HD IL-2
|
22.2%
2/9 • Number of events 2 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • From the initiation of through 48 hours following the final dose of HD IL-2
|
11.1%
1/9 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Investigations
Aspartate aminotransferase increased
|
9.1%
1/11 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
11.1%
1/9 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Investigations
Blood bilirubin increased
|
18.2%
2/11 • Number of events 2 • From the initiation of through 48 hours following the final dose of HD IL-2
|
22.2%
2/9 • Number of events 2 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Investigations
Lymphocyte count decreased
|
18.2%
2/11 • Number of events 2 • From the initiation of through 48 hours following the final dose of HD IL-2
|
33.3%
3/9 • Number of events 3 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Investigations
Platelet count decreased
|
18.2%
2/11 • Number of events 2 • From the initiation of through 48 hours following the final dose of HD IL-2
|
11.1%
1/9 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Investigations
Urine output decreased
|
27.3%
3/11 • Number of events 3 • From the initiation of through 48 hours following the final dose of HD IL-2
|
44.4%
4/9 • Number of events 4 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Investigations
Weight gain
|
27.3%
3/11 • Number of events 3 • From the initiation of through 48 hours following the final dose of HD IL-2
|
33.3%
3/9 • Number of events 3 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Investigations
White blood cell count decreased
|
0.00%
0/11 • From the initiation of through 48 hours following the final dose of HD IL-2
|
11.1%
1/9 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/11 • From the initiation of through 48 hours following the final dose of HD IL-2
|
11.1%
1/9 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Metabolism and nutrition disorders
Hypernatremia
|
9.1%
1/11 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
0.00%
0/9 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Metabolism and nutrition disorders
Hypoalbunemia
|
72.7%
8/11 • Number of events 8 • From the initiation of through 48 hours following the final dose of HD IL-2
|
66.7%
6/9 • Number of events 6 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.1%
1/11 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
22.2%
2/9 • Number of events 2 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
63.6%
7/11 • Number of events 7 • From the initiation of through 48 hours following the final dose of HD IL-2
|
66.7%
6/9 • Number of events 6 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Nervous system disorders
Cerebral edema
|
9.1%
1/11 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
0.00%
0/9 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Nervous system disorders
Somnolence
|
9.1%
1/11 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
0.00%
0/9 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
18.2%
2/11 • Number of events 2 • From the initiation of through 48 hours following the final dose of HD IL-2
|
11.1%
1/9 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • Number of events 1 • From the initiation of through 48 hours following the final dose of HD IL-2
|
0.00%
0/9 • From the initiation of through 48 hours following the final dose of HD IL-2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place