Trial Outcomes & Findings for An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting (NCT NCT02557035)
NCT ID: NCT02557035
Last Updated: 2018-06-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
441 participants
Primary outcome timeframe
0-24 hours
Results posted on
2018-06-20
Participant Flow
Participant milestones
| Measure |
I.V. Palonosetron Infusion Plus Dexamethasone
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
I.V. Palonosetron Bolus Plus Dexamethasone
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
|---|---|---|
|
Overall Study
STARTED
|
225
|
215
|
|
Overall Study
COMPLETED
|
218
|
206
|
|
Overall Study
NOT COMPLETED
|
7
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting
Baseline characteristics by cohort
| Measure |
I.V. Palonosetron Infusion Plus Dexamethasone
n=225 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
I.V. Palonosetron Bolus Plus Dexamethasone
n=215 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
Total
n=440 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
58.9 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
225 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
440 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
ECOG Performance Status
Grade 0
|
97 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
ECOG Performance Status
Grade 1
|
120 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
ECOG Performance Status
Grade 2
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Alcohol consumption
None
|
160 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
|
Alcohol consumption
Occasional
|
58 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Alcohol consumption
Regular
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Tobacco consumption
non-smoker
|
81 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Tobacco consumption
Ex-smoker
|
81 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Tobacco consumption
Regular
|
60 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Tobacco consumption
Occasional
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-24 hoursOutcome measures
| Measure |
I.V. Palonosetron Infusion Plus Dexamethasone
n=225 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
I.V. Palonosetron Bolus Plus Dexamethasone
n=215 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
|---|---|---|
|
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase
|
186 Participants
|
186 Participants
|
SECONDARY outcome
Timeframe: >24-120 hoursOutcome measures
| Measure |
I.V. Palonosetron Infusion Plus Dexamethasone
n=225 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
I.V. Palonosetron Bolus Plus Dexamethasone
n=215 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
|---|---|---|
|
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase
|
170 Participants
|
165 Participants
|
SECONDARY outcome
Timeframe: 0-120 hoursOutcome measures
| Measure |
I.V. Palonosetron Infusion Plus Dexamethasone
n=225 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
I.V. Palonosetron Bolus Plus Dexamethasone
n=215 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
|---|---|---|
|
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase
|
150 Participants
|
156 Participants
|
SECONDARY outcome
Timeframe: 0-24 hoursOutcome measures
| Measure |
I.V. Palonosetron Infusion Plus Dexamethasone
n=225 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
I.V. Palonosetron Bolus Plus Dexamethasone
n=215 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
|---|---|---|
|
Percentage of Patients With no Emetic Episodes in the Acute Phase
|
186 Participants
|
190 Participants
|
SECONDARY outcome
Timeframe: >24-120 hoursOutcome measures
| Measure |
I.V. Palonosetron Infusion Plus Dexamethasone
n=225 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
I.V. Palonosetron Bolus Plus Dexamethasone
n=215 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
|---|---|---|
|
Percentage of Patients With no Emetic Episodes in the Delayed Phase
|
176 Participants
|
168 Participants
|
SECONDARY outcome
Timeframe: 0-120 hoursOutcome measures
| Measure |
I.V. Palonosetron Infusion Plus Dexamethasone
n=225 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
I.V. Palonosetron Bolus Plus Dexamethasone
n=215 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
|---|---|---|
|
Percentage of Patients With no Emetic Episodes in the Overall Phase
|
155 Participants
|
160 Participants
|
SECONDARY outcome
Timeframe: 0-24 hoursOutcome measures
| Measure |
I.V. Palonosetron Infusion Plus Dexamethasone
n=225 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
I.V. Palonosetron Bolus Plus Dexamethasone
n=215 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
|---|---|---|
|
Percentage of Patients With no Rescue Medication in the Acute Phase
|
200 Participants
|
195 Participants
|
SECONDARY outcome
Timeframe: >24-120 hoursOutcome measures
| Measure |
I.V. Palonosetron Infusion Plus Dexamethasone
n=225 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
I.V. Palonosetron Bolus Plus Dexamethasone
n=215 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
|---|---|---|
|
Percentage of Patients With no Rescue Medication in the Delayed Phase
|
183 Participants
|
176 Participants
|
SECONDARY outcome
Timeframe: 0-120 hoursOutcome measures
| Measure |
I.V. Palonosetron Infusion Plus Dexamethasone
n=225 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
I.V. Palonosetron Bolus Plus Dexamethasone
n=215 Participants
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
|---|---|---|
|
Percentage of Patients With no Rescue Medication in the Overall Phase
|
173 Participants
|
169 Participants
|
Adverse Events
I.V. Palonosetron Infusion Plus Dexamethasone
Serious events: 15 serious events
Other events: 14 other events
Deaths: 1 deaths
I.V. Palonosetron Bolus Plus Dexamethasone
Serious events: 12 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
I.V. Palonosetron Infusion Plus Dexamethasone
n=225 participants at risk
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
I.V. Palonosetron Bolus Plus Dexamethasone
n=215 participants at risk
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.44%
1/225 • 7 months
|
0.47%
1/215 • 7 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.89%
2/225 • 7 months
|
1.4%
3/215 • 7 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.89%
2/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Cardiac disorders
Atrial flutter
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Cardiac disorders
Cardiac arrest
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.44%
1/225 • 7 months
|
0.47%
1/215 • 7 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Gastrointestinal disorders
Constipation
|
0.89%
2/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Gastrointestinal disorders
Vomiting
|
0.44%
1/225 • 7 months
|
0.47%
1/215 • 7 months
|
|
General disorders
Asthenia
|
0.89%
2/225 • 7 months
|
0.47%
1/215 • 7 months
|
|
General disorders
Death
|
0.00%
0/225 • 7 months
|
0.93%
2/215 • 7 months
|
|
General disorders
Disease progression
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
General disorders
Pain
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Infections and infestations
Pneumonia
|
0.44%
1/225 • 7 months
|
0.47%
1/215 • 7 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/225 • 7 months
|
0.47%
1/215 • 7 months
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Investigations
Blood creatinine increased
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Investigations
Blood urea increased
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Investigations
ECG signs of myocardial infarction
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Nervous system disorders
Epilepsy
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Nervous system disorders
Transient ischaemic attack
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/225 • 7 months
|
0.47%
1/215 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.44%
1/225 • 7 months
|
0.47%
1/215 • 7 months
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/225 • 7 months
|
0.47%
1/215 • 7 months
|
|
Vascular disorders
Hypotension
|
0.44%
1/225 • 7 months
|
0.00%
0/215 • 7 months
|
Other adverse events
| Measure |
I.V. Palonosetron Infusion Plus Dexamethasone
n=225 participants at risk
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as an infusion with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
I.V. Palonosetron Bolus Plus Dexamethasone
n=215 participants at risk
Intravenous palonosetron (Aloxi 0.25 mg solution for injection) as a bolus with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.
Palonosetron
Dexamethasone
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
3.6%
8/225 • 7 months
|
5.1%
11/215 • 7 months
|
|
General disorders
Asthenia
|
2.7%
6/225 • 7 months
|
5.1%
11/215 • 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60