Trial Outcomes & Findings for Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer (NCT NCT03040726)
NCT ID: NCT03040726
Last Updated: 2023-10-17
Results Overview
Average intensity of nausea over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10, where 0= none and 10= worse possible nausea. The total score ranged from 0-10. We measured the within-group change in nausea intensity from day 5 to day 15. Wilcoxon rank sum test was used for analysis.
COMPLETED
PHASE2/PHASE3
53 participants
Day 5 and Day 15
2023-10-17
Participant Flow
Cancer patients with age \>=18, chronic nausea over the past 4 weeks, an average nausea numeric rating scale (NRS) \>=4/10 over the past 5 days were recruited from the Supportive Care, Gastrointestinal Medical Oncology, Breast Medical Oncology, and the Gastroenterology, Hepatology and Nutrition clinics at the University of Texas MD Anderson Cancer Center.
A total of 53 participants were enrolled but 46 were randomized. 7 participants were not randomized for various reasons that included "Change in cancer treatment" (n=3), "Developed renal failure" (n=1), "Developed bowel obstruction" (n=1) and "Other" (n=2)
Participant milestones
| Measure |
Blinded Intervention gp.
Took one Netupitant/Palonosetron (NEPA) capsule every 5 days for 2 doses
|
Blinded Placebo gp.
Took one Placebo capsule every 5 days for 2 doses
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
15
|
|
Overall Study
Started Placebo run-in Phase
|
31
|
15
|
|
Overall Study
Started Blinded Phase
|
22
|
11
|
|
Overall Study
COMPLETED
|
21
|
9
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
| Measure |
Blinded Intervention gp.
Took one Netupitant/Palonosetron (NEPA) capsule every 5 days for 2 doses
|
Blinded Placebo gp.
Took one Placebo capsule every 5 days for 2 doses
|
|---|---|---|
|
Overall Study
Reasons for not completing Placebo run in phase phase; Drop Out
|
4
|
0
|
|
Overall Study
Reasons for not completing Placebo run in phase phase; withdrawal
|
1
|
1
|
|
Overall Study
Reasons for not completing Placebo run in phase: Nausea NRS score >4
|
4
|
3
|
|
Overall Study
Reasons for not completing Blinded phase: Hospitalization
|
0
|
2
|
|
Overall Study
Reasons for not completing Blinded phase : Withdrawal
|
1
|
0
|
Baseline Characteristics
Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer
Baseline characteristics by cohort
| Measure |
Blinded Intervention gp.
n=31 Participants
Took one Netupitant/Palonosetron (NEPA) capsule every 5 days for 2 doses
|
Blinded Placebo gp.
n=15 Participants
Took Placebo capsule every 5 days for 2 doses
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.2 years
n=5 Participants
|
52.7 years
n=7 Participants
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
33 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
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Cancer Stage
Metastatic
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Cancer Stage
Locally advanced
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Cancer Stage
Recurrent or persistent
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cancer Type
Breast
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Cancer Type
Gastrointestinal
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Cancer Type
Genitourinary
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cancer Type
Respiratory
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Cancer Type
Hematology
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cancer Type
Gynaecological
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Cancer Type
Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 5 and Day 15Population: Those who completed Day 15
Average intensity of nausea over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10, where 0= none and 10= worse possible nausea. The total score ranged from 0-10. We measured the within-group change in nausea intensity from day 5 to day 15. Wilcoxon rank sum test was used for analysis.
Outcome measures
| Measure |
Blinded Intervention Group
n=21 Participants
Netupitant/Palonosetron (NEPA) capsule every 5 days for 2 doses
|
Blinded Placebo Group
n=10 Participants
Placebo capsule every 5 days for 2 doses
|
|---|---|---|
|
Change in Nausea Numerical Rating Scale (NRS) Between Day 5 and Day 15
|
-2.0 score on a scale
Interval -3.1 to -0.8
|
-2.3 score on a scale
Interval -3.9 to -0.7
|
SECONDARY outcome
Timeframe: Baseline and Day 15Population: Those who completed Day 15
FLIE is a questionnaire validated to assess the impact of chemotherapy induced nausea and vomiting on patient's function and quality of life over the past 5 days. It consists of 18 items, with 9 items on nausea and 9 items on vomiting. Each question was rated using a Numerical Rating Scale (NRS) from 1 to 7. The total Nausea sub-score ranges from 9 to 63, where a higher score indicates higher quality of life. We measured the change of nausea sub-score between baseline 5 to day 15. Wilcoxon rank sum test was used for analysis.
Outcome measures
| Measure |
Blinded Intervention Group
n=21 Participants
Netupitant/Palonosetron (NEPA) capsule every 5 days for 2 doses
|
Blinded Placebo Group
n=9 Participants
Placebo capsule every 5 days for 2 doses
|
|---|---|---|
|
Functional Living Index Emesis (FLIE): Nausea Sub-score
|
-16.6 score on a scale
Interval -22.6 to -10.5
|
-18 score on a scale
Interval -22.0 to -14.0
|
SECONDARY outcome
Timeframe: Baseline and Day 15Population: Those who completed Day 15
FLIE is a questionnaire validated to assess the impact of chemotherapy induced nausea and vomiting on patient's function and quality of life over the past 5 days. It consists of 18 items, with 9 items on nausea and 9 items on vomiting. Each question was rated using a Numerical Rating Scale (NRS) from 1 to 7. The total Vomiting sub-score ranges from 9 to 63, where a higher score indicates higher quality of life. We measured the change of vomiting sub-score from baseline to day 15.Wilcoxon rank sum test was used for analysis.
Outcome measures
| Measure |
Blinded Intervention Group
n=21 Participants
Netupitant/Palonosetron (NEPA) capsule every 5 days for 2 doses
|
Blinded Placebo Group
n=9 Participants
Placebo capsule every 5 days for 2 doses
|
|---|---|---|
|
Functional Living Index Emesis (FLIE): Vomiting Sub-score
|
-12.5 score on a scale
Interval -20.8 to -4.2
|
-9.7 score on a scale
Interval -18.2 to -1.2
|
SECONDARY outcome
Timeframe: Day 5 and Day 15Population: Those who completed Day 15
Index of Nausea, Vomiting, and Retching, which consists of 8 items asking about the patient's experience regarding nausea and vomiting over the past 12 hours. Each item included a 5-point Likert scale (0-4 points) with descriptive words. Total experience score ranged from 0-32 with higher score indicates more nausea/vomiting. We measured the change in score between day 5 and day 15. Wilcoxon rank sum test was used for analysis.
Outcome measures
| Measure |
Blinded Intervention Group
n=21 Participants
Netupitant/Palonosetron (NEPA) capsule every 5 days for 2 doses
|
Blinded Placebo Group
n=10 Participants
Placebo capsule every 5 days for 2 doses
|
|---|---|---|
|
Index of Nausea, Vomiting and Retching: Total Experience Score
|
-2.3 score on a scale
Interval -4.4 to -0.3
|
-2.5 score on a scale
Interval -6.9 to 1.9
|
Adverse Events
Blinded Intervention gp.
Placebo gp.
Serious adverse events
| Measure |
Blinded Intervention gp.
n=30 participants at risk
Took one Netupitant/Palonosetron (NEPA) capsule every 5 days for 2 doses
|
Placebo gp.
n=43 participants at risk
Took one Placebo capsule every 5 days for 2 doses
|
|---|---|---|
|
Gastrointestinal disorders
Dehydration
|
3.3%
1/30 • Study Day 15
Adverse events were assessed within 15 study days
|
0.00%
0/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
Gastrointestinal disorders
Hepatic failure
|
3.3%
1/30 • Study Day 15
Adverse events were assessed within 15 study days
|
0.00%
0/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/30 • Study Day 15
Adverse events were assessed within 15 study days
|
2.3%
1/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
Renal and urinary disorders
Acute Kidney imjury
|
0.00%
0/30 • Study Day 15
Adverse events were assessed within 15 study days
|
2.3%
1/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
General disorders
Death NOS
|
0.00%
0/30 • Study Day 15
Adverse events were assessed within 15 study days
|
4.7%
2/43 • Study Day 15
Adverse events were assessed within 15 study days
|
Other adverse events
| Measure |
Blinded Intervention gp.
n=30 participants at risk
Took one Netupitant/Palonosetron (NEPA) capsule every 5 days for 2 doses
|
Placebo gp.
n=43 participants at risk
Took one Placebo capsule every 5 days for 2 doses
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Study Day 15
Adverse events were assessed within 15 study days
|
0.00%
0/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.3%
1/30 • Study Day 15
Adverse events were assessed within 15 study days
|
0.00%
0/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.3%
1/30 • Study Day 15
Adverse events were assessed within 15 study days
|
2.3%
1/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/30 • Study Day 15
Adverse events were assessed within 15 study days
|
2.3%
1/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
Nervous system disorders
Headache
|
10.0%
3/30 • Study Day 15
Adverse events were assessed within 15 study days
|
7.0%
3/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/30 • Study Day 15
Adverse events were assessed within 15 study days
|
2.3%
1/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
Gastrointestinal disorders
Stomach pain
|
0.00%
0/30 • Study Day 15
Adverse events were assessed within 15 study days
|
2.3%
1/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
Gastrointestinal disorders
Constipation
|
3.3%
1/30 • Study Day 15
Adverse events were assessed within 15 study days
|
2.3%
1/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
General disorders
Edema face
|
0.00%
0/30 • Study Day 15
Adverse events were assessed within 15 study days
|
2.3%
1/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
General disorders
Edema legs
|
6.7%
2/30 • Study Day 15
Adverse events were assessed within 15 study days
|
0.00%
0/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
General disorders
Fatigue
|
6.7%
2/30 • Study Day 15
Adverse events were assessed within 15 study days
|
0.00%
0/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
3.3%
1/30 • Study Day 15
Adverse events were assessed within 15 study days
|
0.00%
0/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
3.3%
1/30 • Study Day 15
Adverse events were assessed within 15 study days
|
0.00%
0/43 • Study Day 15
Adverse events were assessed within 15 study days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
3.3%
1/30 • Study Day 15
Adverse events were assessed within 15 study days
|
0.00%
0/43 • Study Day 15
Adverse events were assessed within 15 study days
|
Additional Information
Dr. David Hui
The University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place