Trial Outcomes & Findings for Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients (NCT NCT01370408)
NCT ID: NCT01370408
Last Updated: 2017-04-17
Results Overview
Proportion of patients achieving a delayed CINV complete response (CR) defined as no emetic episode and no use of rescue medications during the 24-120 hour period post chemotherapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
85 participants
Primary outcome timeframe
120 hours
Results posted on
2017-04-17
Participant Flow
Participant milestones
| Measure |
Palonosetron
All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
|
|---|---|
|
Overall Study
STARTED
|
85
|
|
Overall Study
COMPLETED
|
76
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Palonosetron
All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
|
|---|---|
|
Overall Study
treatment failure
|
9
|
Baseline Characteristics
Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients
Baseline characteristics by cohort
| Measure |
Palonosetron
n=85 Participants
All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 120 hoursProportion of patients achieving a delayed CINV complete response (CR) defined as no emetic episode and no use of rescue medications during the 24-120 hour period post chemotherapy.
Outcome measures
| Measure |
Palonosetron
n=85 Participants
All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
|
|---|---|
|
Complete Response Rate for Delayed Chemotherapy Induced Nausea & Vomiting
|
13 participants
|
SECONDARY outcome
Timeframe: 24 hoursProportion of patients achieving an acute CINV CR during the acute phase post -chemotherapy (0-24 hours)
Outcome measures
| Measure |
Palonosetron
n=85 Participants
All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
|
|---|---|
|
Complete Remission During Acute Phase Post-chemotherapy
|
33 participants
|
SECONDARY outcome
Timeframe: 120 hoursProportion of patients achieving a CR during the cumulative overall 0-120 hour time period
Outcome measures
| Measure |
Palonosetron
n=85 Participants
All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
|
|---|---|
|
Complete Remission During Overall Chemotherapy Time Period
|
10 participants
|
SECONDARY outcome
Timeframe: 120 hoursComplete control rate (CC; defined as no emetic episodes, no rescue medication use, and no more than mild nausea)
Outcome measures
| Measure |
Palonosetron
n=85 Participants
All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
|
|---|---|
|
Complete Control Rate for Nausea & Vomiting
|
8 participants
|
SECONDARY outcome
Timeframe: 120 HoursNumber of emetic episodes
Outcome measures
| Measure |
Palonosetron
n=85 Participants
All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
|
|---|---|
|
Emetic Episodes
|
1.7 episodes
Interval 1.0 to 24.0
|
SECONDARY outcome
Timeframe: 24 hoursNumber of patients with first emetic episode experienced within 24 hours
Outcome measures
| Measure |
Palonosetron
n=85 Participants
All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
|
|---|---|
|
Patients Who Experience First Emetic Episode Within 24 Hours
|
15 participants
|
SECONDARY outcome
Timeframe: 24 hoursNumber of patients who required the use of rescue medication (lorazepam, prochlorperazine, promethazine, metoclopramide, scopolamine, or dronabinol) within the first 24 hours
Outcome measures
| Measure |
Palonosetron
n=85 Participants
All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
|
|---|---|
|
Number of Patients That Required First Administration of Rescue Medication Within 24 Hours
|
46 participants
|
SECONDARY outcome
Timeframe: 24 hoursNumber of patients with first emetic episode or time to administration of rescue therapy, whichever occurred first, within the first 24 hours
Outcome measures
| Measure |
Palonosetron
n=85 Participants
All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
|
|---|---|
|
Number of Patients That Experience Treatment Failure Within the First 24 Hours
|
49 participants
|
Adverse Events
Palonosetron
Serious events: 0 serious events
Other events: 85 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Palonosetron
n=85 participants at risk
All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation
Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV \& Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
|
|---|---|
|
Gastrointestinal disorders
abdominal distension
|
7.1%
6/85
|
|
Gastrointestinal disorders
abdominal cramping
|
22.4%
19/85
|
|
Hepatobiliary disorders
increased alkaline phosphatase
|
12.9%
11/85
|
|
Hepatobiliary disorders
increased ALT
|
9.4%
8/85
|
|
Blood and lymphatic system disorders
neutropenia
|
76.5%
65/85
|
|
Blood and lymphatic system disorders
anemia
|
62.4%
53/85
|
|
Gastrointestinal disorders
anorexia
|
17.6%
15/85
|
|
Psychiatric disorders
anxiety
|
37.6%
32/85
|
|
Hepatobiliary disorders
increased AST
|
22.4%
19/85
|
|
Gastrointestinal disorders
abdominal tenderness
|
8.2%
7/85
|
|
Musculoskeletal and connective tissue disorders
back pain
|
5.9%
5/85
|
|
Gastrointestinal disorders
rectal bleeding
|
7.1%
6/85
|
|
Skin and subcutaneous tissue disorders
bruising
|
5.9%
5/85
|
|
Investigations
chills
|
11.8%
10/85
|
|
Gastrointestinal disorders
constipation
|
21.2%
18/85
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
9.4%
8/85
|
|
Gastrointestinal disorders
decreased appetite
|
43.5%
37/85
|
|
Investigations
deconditioning
|
5.9%
5/85
|
|
Gastrointestinal disorders
diarrhea
|
56.5%
48/85
|
|
Nervous system disorders
dizziness
|
23.5%
20/85
|
|
Skin and subcutaneous tissue disorders
dry skin
|
5.9%
5/85
|
|
Gastrointestinal disorders
dry mouth
|
17.6%
15/85
|
|
Renal and urinary disorders
dysuria
|
12.9%
11/85
|
|
Cardiac disorders
lower extremity edema
|
17.6%
15/85
|
|
Investigations
fatigue
|
65.9%
56/85
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
12.9%
11/85
|
|
Nervous system disorders
headache
|
28.2%
24/85
|
|
Gastrointestinal disorders
hiccups
|
8.2%
7/85
|
|
Hepatobiliary disorders
hyperbilirubinemia
|
16.5%
14/85
|
|
Metabolism and nutrition disorders
hyperglycemia
|
55.3%
47/85
|
|
Metabolism and nutrition disorders
hypermagnesemia
|
9.4%
8/85
|
|
Metabolism and nutrition disorders
hypernatremia
|
12.9%
11/85
|
|
Cardiac disorders
hypertension
|
10.6%
9/85
|
|
Hepatobiliary disorders
hypoalbuminemia
|
38.8%
33/85
|
|
Metabolism and nutrition disorders
hypocalcemia
|
38.8%
33/85
|
|
Metabolism and nutrition disorders
hypoglycemia
|
7.1%
6/85
|
|
Metabolism and nutrition disorders
hypokalemia
|
27.1%
23/85
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
10.6%
9/85
|
|
Metabolism and nutrition disorders
hyponatremia
|
16.5%
14/85
|
|
Cardiac disorders
hypotension
|
14.1%
12/85
|
|
Psychiatric disorders
insomnia
|
27.1%
23/85
|
|
Blood and lymphatic system disorders
lymphopenia
|
28.2%
24/85
|
|
Nervous system disorders
memory changes
|
7.1%
6/85
|
|
Gastrointestinal disorders
mouth pain
|
12.9%
11/85
|
|
Gastrointestinal disorders
mouth sores
|
10.6%
9/85
|
|
Gastrointestinal disorders
mucositis
|
22.4%
19/85
|
|
Gastrointestinal disorders
nausea
|
87.1%
74/85
|
|
Infections and infestations
neutropenic fever
|
16.5%
14/85
|
|
Nervous system disorders
peripheral neuropathy
|
8.2%
7/85
|
|
Skin and subcutaneous tissue disorders
pruritus
|
7.1%
6/85
|
|
Skin and subcutaneous tissue disorders
rash
|
17.6%
15/85
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea
|
5.9%
5/85
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath with exertion
|
14.1%
12/85
|
|
Gastrointestinal disorders
sore throat
|
20.0%
17/85
|
|
Cardiac disorders
tachycardia
|
22.4%
19/85
|
|
Gastrointestinal disorders
taste alteration
|
5.9%
5/85
|
|
Gastrointestinal disorders
throat pain
|
9.4%
8/85
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
62.4%
53/85
|
|
Renal and urinary disorders
urinary frequency
|
8.2%
7/85
|
|
Gastrointestinal disorders
vomiting
|
57.6%
49/85
|
|
Blood and lymphatic system disorders
leukopenia
|
87.1%
74/85
|
|
Investigations
generalized weakness
|
18.8%
16/85
|
Additional Information
Dr. Scott Solomon
Blood and Marrow Transplant Group of Georgia
Phone: 404-255-1930
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place