An Efficacy and Safety Study of Intravenous Palonosetron Administered as an Infusion and as a Bolus for the Prevention of Nausea and Vomiting

• Sponsor: Helsinn Healthcare SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02557035
• Collaborator: PSI CRO (Industry)
• Enrollment: 441
• Locations: 76
• Arms: 2
• Duration (Months): 5
• Patients Per Site: 5.8
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

PALO-15-17 is a clinical study assessing efficacy and safety of a single dose of palonosetron 0.25 mg administered as a 30-minute IV infusion compared to palonosetron 0.25 mg administered as a 30-second IV bolus (Aloxi, an antiemetic drug), both given with oral dexamethasone. The objective of the study is to demonstrate that infused IV palonosetron 0.25 mg is as effective as (non-inferior to) injected palonosetron IV 0.25 mg to prevent nausea and vomiting induced by highly emetogenic cancer chemotherapy in the 0-24 hours after administration of a single cycle of highly emetogenic chemotherapy

Condition or Disease	Intervention/Treatment	Phase
Chemotherapy-Induced Nausea and Vomiting	Drug: Palonosetron; Drug: Dexamethasone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 441 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Phase 3, Single-dose, Multicenter, Randomized, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of Palonosetron 0.25 mg Administered as a 30-minute IV Infusion Compared to Palonosetron 0.25 mg Administered as a 30-second IV Bolus for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Chemotherapy.
• Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Palonosetron; Drug: Dexamethasone
Active Comparator: 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.	Drug: Palonosetron; Drug: Dexamethasone

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase [0-24 hours]

Secondary Outcome Measures

1. Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase [>24-120 hours]

2. Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase [0-120 hours]

3. Percentage of Patients With no Emetic Episodes in the Acute Phase [0-24 hours]

4. Percentage of Patients With no Emetic Episodes in the Delayed Phase [>24-120 hours]

5. Percentage of Patients With no Emetic Episodes in the Overall Phase [0-120 hours]

6. Percentage of Patients With no Rescue Medication in the Acute Phase [0-24 hours]

7. Percentage of Patients With no Rescue Medication in the Delayed Phase [>24-120 hours]

8. Percentage of Patients With no Rescue Medication in the Overall Phase [0-120 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Signed written informed consent

• Histologically or cytologically confirmed solid tumor malignancy.

• Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy will be permitted.

• Scheduled to receive first course of one of the following reference HEC, alone or in combination with other chemotherapeutic agents on Day 1:

• cisplatin administered as a single IV dose of ≥ 70 mg/m2

• cyclophosphamide ≥1500 mg/m2

• carmustine (BCNU) >250 mg/m2

• dacarbazine (DTIC)

• mechloretamine (nitrogen mustard)

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 .

• If a patient is female, she shall be of non-childbearing potential or of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test.

• Hematologic and metabolic status adequate for receiving an highly emetogenic regimen based on laboratory criteria (Total Neutrophils,Platelets, Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance)

• Able to read, understand, follow the study procedure and complete patient diary.

Exclusion Criteria:

• Lactating woman.

• Current use of illicit drugs or current evidence of alcohol abuse.

• Scheduled to receive moderately emetogenic chemotherapy or highly emetogenic chemotherapy from Day 2 to Day 5.

• Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to the start of the reference HEC administration on Day 1 or between Days 1 to 5.

• Any vomiting, retching, or nausea (grade ≥ 1 as defined by National Cancer Institute) within 24 hours prior to the start of the reference HEC administration on Day 1.

• Symptomatic primary or metastatic CNS malignancy.

• Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any illness or medical conditions (other than malignancy) that, in the opinion of the Investigator, may confound the results of the study, represent another potential etiology for emesis and nausea (other than chemotherapy-induced nausea and vomiting) or pose unwarranted risks in administering the study drugs to the patient.

• Known hypersensitivity or contraindication to 5-HT3 receptor antagonists

• Known contraindication to the IV administration of 50 mL 5% glucose solution.

• Participation in a previous clinical trial involving palonosetron.

• Any investigational drugs (other than those given in this study) taken within 4 weeks prior to Day 1, and/or is scheduled to receive any investigational drug during the present study.

• Systemic corticosteroid therapy at any dose within 72 hours prior to the start of the reference HEC administration on Day 1. However, topical and inhaled corticosteroids are permitted.

• Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.

• Any medication with known or potential antiemetic activity within 24 hours prior to the start of the reference HEC administration on Day 1, including but not limited to 5-HT3 receptor antagonists and NK-1 receptor antagonists

• Concurrent medical condition that would preclude administration of dexamethasone for 4 days such as systemic fungal infection or uncontrolled diabetes.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center, Department of Chemotherapy	Lesnoy		Belarus	223052
2	Minsk City Clinical Oncology Center	Minsk		Belarus	220013
3	University Clinical Centre of the Republic of Srpska	Banja Luka		Bosnia and Herzegovina
4	Multiprofile Hospital for Active Treatment, Dobrich, Department of Medical Oncology	Dobrich		Bulgaria	9300
5	Specialized Hospital for Active Treatment in Oncology, Haskovo, Department of Medical Oncology	Haskovo		Bulgaria	6300
6	Multiprofile Hospital for Active Treatment "Central Onco Hospital", Plovdiv, Department of Medical Oncology	Plovdiv		Bulgaria	4002
7	Complex Oncology Center, Ruse, Department of Medical Oncology	Rousse		Bulgaria	7002
8	Multiprofile Hospital for Active Treatment "Serdika", Sofia, Department of Medical Oncology	Sofia		Bulgaria	1303
9	University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Department of Medical Oncology	Sofia		Bulgaria	1431
10	Multiprofile Hospital for Active Treatment for Wonen's Health "Nadezhda"	Sofia		Bulgaria
11	Hospital for Active Treatment of Oncological Diseases "Dr. Marko Antonov Markov", Varna, Department of Medicinal Oncology and Palliative Care	Varna		Bulgaria	9010
12	Multiprofile Hospital for Active Treatment "Sveta Marina", Varna, Clinic of Medical Oncology	Varna		Bulgaria	9010
13	JSC NeoMedi	Tbilisi		Georgia	0131
14	LTD Institute of Clinical Oncology	Tbilisi		Georgia	0159
15	LTD Aversi Clinic	Tbilisi		Georgia	0160
16	LDT High Technology Medical Center University Clinic	Tbilisi		Georgia
17	"Sotiria" Chest Diseases Hospital of Athens	Athens		Greece
18	Thermi Clinic S.A.	Thessaloniki		Greece	570 01
19	General Hospital of Thessaloniki "G. Papanikolaou", University Department of Pulmonology	Thessaloniki		Greece	570 10
20	Bioclinic Thessalonikis S.A.	Thessaloniki		Greece
21	Koranyi National Institute of TBC and Pulmonology	Budapest		Hungary	1121
22	Uzsoki Hospital, Department of Radiation Oncology	Budapest		Hungary	1145
23	University of Debrecen, Medical and Health Science Center	Debrecen		Hungary
24	Petz Aladar County Teaching Hospital, Center for Oncoradiology	Gyor		Hungary	9024
25	Kaposi Mor Teaching Hospital, Centre for Clinical Oncology	Kaposvár		Hungary	7400
26	Borsod-Abauj-Zemplen County Hospital and University Educational Hospital	Miskolc		Hungary	3526
27	Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital	Nyíregyháza		Hungary
28	Medical Center of the University of Pecs	Pecs		Hungary
29	Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Oncology Hospital, Department of Conservative Oncology	Kaunas		Lithuania	45434
30	Hospital of Lithuanian University of Health Sciences Kaunas Clinics, Clinic of Oncology and Hematology	Kaunas		Lithuania	50009
31	Oncopremium Team SRL, Department of Oncology	Baia Mare		Romania
32	Prof. Dr. Alexandru Trestioreanu Institute of Oncology, Medical Oncology Department II	Bucharest		Romania	022328
33	Coltea Clinical Hospital, Department of Medical Oncology	Bucharest		Romania	030171
34	Hifu Terramed Conformal SRL, Department of Medical Oncology	Bucharest		Romania	031864
35	Ianuli Med Consult SRL, Oncology Department	Bucharest		Romania
36	"Prof. Dr. Ion Chiricuta" Institute of Oncology, Radiotherapy Department I	Cluj-Napoca		Romania	400015
37	Radiotherapy Center Cluj SRL, Department of Oncology	Cluj-Napoca		Romania
38	Constanta Emergency Clinical County Hospital, Department of Medical Oncology	Constanta		Romania	900591
39	Oncology Center "Sf. Nectarie", Department of Medical Oncology	Craiova		Romania
40	Suceava Sf. Ioan cel Nou Emergency County Hospital, Department of Medical Oncology	Suceava		Romania	720237
41	Oncomed SRL, Department of Medical Oncology	Timisoara		Romania	300239
42	Oncocenter Clinical Oncology SRL, Department of Medical Oncology	Timisoara		Romania
43	Arkhangelsk Clinical Oncology Center	Arkhangelsk		Russian Federation
44	Altay Territorial Oncology Center	Barnaul		Russian Federation
45	Bryansk Regional Oncology Center	Bryansk		Russian Federation
46	Chelyabinsk Regional Clinical Oncology Center	Chelyabinsk		Russian Federation
47	Evimed, LLC	Chelyabinsk		Russian Federation
48	Sverdlovsk Regional Oncology Center	Ekaterinburg		Russian Federation
49	Ivanovo Regional Oncology Center	Ivanovo		Russian Federation
50	Kaluga Regional Oncology Center	Kaluga		Russian Federation
51	Republican Clinical Oncology Center	Kazan		Russian Federation
52	Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center	Krasnoyarsk		Russian Federation
53	Moscow City Oncology Hospital #62	Moscow		Russian Federation
54	Moscow Clinical Scientific and Practical Center	Moscow		Russian Federation
55	N.N. Blokhin Russian Oncology Research Center, Surgery Dept. 2	Moscow		Russian Federation
56	N.N. Blokhin Russian Oncology Research Center, Surgery Dept. of Female Reproductive System Tumors	Moscow		Russian Federation
57	N.N. Blokhin Russian Oncology Research Center	Moscow		Russian Federation
58	Branch #1 of Nizhny Novgorod Regional Oncology Center	Nizhny Novgorod		Russian Federation
59	City Clinical Hospital #1	Novosibirsk		Russian Federation
60	Novosibirsk Regional Oncology Center	Novosibirsk		Russian Federation
61	Clinical Oncology Center, Dept. of Chemotherapy	Omsk		Russian Federation
62	Clinical Oncology Center	Omsk		Russian Federation
63	Orenburg Regional Clinical Oncology Center	Orenburg		Russian Federation
64	Pyatigorsk Oncology Center	Pyatigorsk		Russian Federation
65	Regional Clinical Oncology Center	Ryazan		Russian Federation
66	Samara Regional Clinical Oncology Center	Samara		Russian Federation
67	City Clinical Oncology Center, Thoracic Oncology Dept.	St. Petersburg		Russian Federation
68	City Clinical Oncology Center, Urology Oncology Dept.	St. Petersburg		Russian Federation
69	City Clinical Oncology Center	St. Petersburg		Russian Federation
70	First I.P. Pavlov State Medical University of St. Petersburg	St. Petersburg		Russian Federation
71	St.Petersburg Municipal Clinical Oncology Center	St. Petersburg		Russian Federation
72	Tambov Regional Oncology Center	Tambov		Russian Federation
73	Tomsk Research Institute of Oncology, General Oncology Dept.	Tomsk		Russian Federation
74	Tomsk Research Institute of Oncology	Tomsk		Russian Federation
75	Republican Clinical Oncology Center	Ufa		Russian Federation
76	Regional Clinical Oncology Center	Veliky Novgorod		Russian Federation

Sponsors and Collaborators

• Helsinn Healthcare SA
• PSI CRO

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Helsinn Healthcare SA
• ClinicalTrials.gov Identifier: NCT02557035
• Other Study ID Numbers: PALO-15-17
• First Posted: Sep 22, 2015
• Last Update Posted: Jun 20, 2018
• Last Verified: Jun 1, 2018

• Additional relevant MeSH terms: Nausea; Vomiting; Dexamethasone; Palonosetron

Study Results

Participant Flow

Arm/Group Title	I.V. Palonosetron Infusion Plus Dexamethasone	I.V. Palonosetron Bolus Plus Dexamethasone
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	225	215
COMPLETED	218	206
NOT COMPLETED	7	9

Baseline Characteristics

Arm/Group Title	I.V. Palonosetron Infusion Plus Dexamethasone	I.V. Palonosetron Bolus Plus Dexamethasone	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	225	215	440
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.9 (8.7)	58.9 (8.5)	59.4 (8.6)
Sex: Female, Male (Count of Participants)
Female	74 32.9%	71 33%	145 33%
Male	151 67.1%	144 67%	295 67%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	225 100%	215 100%	440 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
ECOG Performance Status (Count of Participants)
Grade 0	97 43.1%	109 50.7%	206 46.8%
Grade 1	120 53.3%	100 46.5%	220 50%
Grade 2	8 3.6%	6 2.8%	14 3.2%
Alcohol consumption (Count of Participants)
None	160 71.1%	145 67.4%	305 69.3%
Occasional	58 25.8%	67 31.2%	125 28.4%
Regular	7 3.1%	3 1.4%	10 2.3%
Tobacco consumption (Count of Participants)
non-smoker	81 36%	77 35.8%	158 35.9%
Ex-smoker	81 36%	70 32.6%	151 34.3%
Regular	60 26.7%	66 30.7%	126 28.6%
Occasional	3 1.3%	2 0.9%	5 1.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase
Time Frame	0-24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I.V. Palonosetron Infusion Plus Dexamethasone	I.V. Palonosetron Bolus Plus Dexamethasone
Arm/Group Description	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	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
Measure Participants	225	215
Count of Participants [Participants]	186 82.7%	186 86.5%

2. Secondary Outcome

Title	Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase
Time Frame	>24-120 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I.V. Palonosetron Infusion Plus Dexamethasone	I.V. Palonosetron Bolus Plus Dexamethasone
Arm/Group Description	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	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
Measure Participants	225	215
Count of Participants [Participants]	170 75.6%	165 76.7%

3. Secondary Outcome

Title	Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase
Time Frame	0-120 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I.V. Palonosetron Infusion Plus Dexamethasone	I.V. Palonosetron Bolus Plus Dexamethasone
Arm/Group Description	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	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
Measure Participants	225	215
Count of Participants [Participants]	150 66.7%	156 72.6%

4. Secondary Outcome

Title	Percentage of Patients With no Emetic Episodes in the Acute Phase
Time Frame	0-24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I.V. Palonosetron Infusion Plus Dexamethasone	I.V. Palonosetron Bolus Plus Dexamethasone
Arm/Group Description	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	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
Measure Participants	225	215
Count of Participants [Participants]	186 82.7%	190 88.4%

5. Secondary Outcome

Title	Percentage of Patients With no Emetic Episodes in the Delayed Phase
Time Frame	>24-120 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I.V. Palonosetron Infusion Plus Dexamethasone	I.V. Palonosetron Bolus Plus Dexamethasone
Arm/Group Description	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	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
Measure Participants	225	215
Count of Participants [Participants]	176 78.2%	168 78.1%

6. Secondary Outcome

Title	Percentage of Patients With no Emetic Episodes in the Overall Phase
Time Frame	0-120 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I.V. Palonosetron Infusion Plus Dexamethasone	I.V. Palonosetron Bolus Plus Dexamethasone
Arm/Group Description	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	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
Measure Participants	225	215
Count of Participants [Participants]	155 68.9%	160 74.4%

7. Secondary Outcome

Title	Percentage of Patients With no Rescue Medication in the Acute Phase
Time Frame	0-24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I.V. Palonosetron Infusion Plus Dexamethasone	I.V. Palonosetron Bolus Plus Dexamethasone
Arm/Group Description	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	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
Measure Participants	225	215
Count of Participants [Participants]	200 88.9%	195 90.7%

8. Secondary Outcome

Title	Percentage of Patients With no Rescue Medication in the Delayed Phase
Time Frame	>24-120 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I.V. Palonosetron Infusion Plus Dexamethasone	I.V. Palonosetron Bolus Plus Dexamethasone
Arm/Group Description	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	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
Measure Participants	225	215
Count of Participants [Participants]	183 81.3%	176 81.9%

9. Secondary Outcome

Title	Percentage of Patients With no Rescue Medication in the Overall Phase
Time Frame	0-120 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	I.V. Palonosetron Infusion Plus Dexamethasone	I.V. Palonosetron Bolus Plus Dexamethasone
Arm/Group Description	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	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
Measure Participants	225	215
Count of Participants [Participants]	173 76.9%	169 78.6%

Adverse Events

Time Frame	7 months
Arm/Group Title	I.V. Palonosetron Infusion Plus Dexamethasone		I.V. Palonosetron Bolus Plus Dexamethasone
Arm/Group Description	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		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
All Cause Mortality
	I.V. Palonosetron Infusion Plus Dexamethasone		I.V. Palonosetron Bolus Plus Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/225 (0.4%)		0/215 (0%)
Serious Adverse Events
	I.V. Palonosetron Infusion Plus Dexamethasone		I.V. Palonosetron Bolus Plus Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/225 (6.7%)		12/215 (5.6%)
Blood and lymphatic system disorders
Leukopenia	1/225 (0.4%)		1/215 (0.5%)
Neutropenia	2/225 (0.9%)		3/215 (1.4%)
Thrombocytopenia	1/225 (0.4%)		0/215 (0%)
Cardiac disorders
Atrial fibrillation	2/225 (0.9%)		0/215 (0%)
Atrial flutter	1/225 (0.4%)		0/215 (0%)
Cardiac arrest	1/225 (0.4%)		0/215 (0%)
Cardio-respiratory arrest	1/225 (0.4%)		1/215 (0.5%)
Gastrointestinal disorders
Abdominal pain	1/225 (0.4%)		0/215 (0%)
Constipation	2/225 (0.9%)		0/215 (0%)
Mesenteric vein thrombosis	1/225 (0.4%)		0/215 (0%)
Vomiting	1/225 (0.4%)		1/215 (0.5%)
General disorders
Asthenia	2/225 (0.9%)		1/215 (0.5%)
Death	0/225 (0%)		2/215 (0.9%)
Disease progression	1/225 (0.4%)		0/215 (0%)
Pain	1/225 (0.4%)		0/215 (0%)
Infections and infestations
Pneumonia	1/225 (0.4%)		1/215 (0.5%)
Sepsis	0/225 (0%)		1/215 (0.5%)
Injury, poisoning and procedural complications
Brain contusion	1/225 (0.4%)		0/215 (0%)
Subdural haematoma	1/225 (0.4%)		0/215 (0%)
Investigations
Blood creatinine increased	1/225 (0.4%)		0/215 (0%)
Blood urea increased	1/225 (0.4%)		0/215 (0%)
ECG signs of myocardial infarction	1/225 (0.4%)		0/215 (0%)
Metabolism and nutrition disorders
Dehydration	1/225 (0.4%)		0/215 (0%)
Hypokalaemia	1/225 (0.4%)		0/215 (0%)
Hyponatraemia	1/225 (0.4%)		0/215 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression	1/225 (0.4%)		0/215 (0%)
Nervous system disorders
Epilepsy	1/225 (0.4%)		0/215 (0%)
Transient ischaemic attack	1/225 (0.4%)		0/215 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/225 (0.4%)		0/215 (0%)
Pulmonary embolism	0/225 (0%)		1/215 (0.5%)
Respiratory failure	1/225 (0.4%)		1/215 (0.5%)
Skin and subcutaneous tissue disorders
Angioedema	1/225 (0.4%)		0/215 (0%)
Dermatitis allergic	0/225 (0%)		1/215 (0.5%)
Vascular disorders
Hypotension	1/225 (0.4%)		0/215 (0%)
Other (Not Including Serious) Adverse Events
	I.V. Palonosetron Infusion Plus Dexamethasone		I.V. Palonosetron Bolus Plus Dexamethasone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/225 (6.2%)		22/215 (10.2%)
Blood and lymphatic system disorders
Neutropenia	8/225 (3.6%)		11/215 (5.1%)
General disorders
Asthenia	6/225 (2.7%)		11/215 (5.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.