An Efficacy and Safety Study of Intravenous Palonosetron... | NCT02557035

Status Module

Name	Class
PSI CRO	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I.V. palonosetron infusion plus dexamethasone	Experimental	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
I.V. palonosetron bolus plus dexamethasone	Active Comparator	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

Name	Type	Description	Arm Group Labels	Other Names
Palonosetron	Drug		I.V. palonosetron bolus plus dexamethasone I.V. palonosetron infusion plus dexamethasone
Dexamethasone

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

Measure	Description	Time Frame
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase		>24-120 hours
Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase		0-120 hours

Eligibility Module

Eligibility Criteria

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.

Facility	Status	City	State	ZIP	Country	Contacts
N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center, Department of Chemotherapy		Lesnoy		223052	Belarus

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00059.9± 8.7 BG00158.9± 8.5 BG00259.4± 8.6

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00074 BG00171 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

ECOG Performance Status

The ECOG Scale is a standard criteria for measuring how the cancer disease impacts a patient's daily living abilities (known to physicians and researchers as a patient's performance status). It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). There 6 grades, where the performance gets worsening from 0 (patient is fully active, able to carry on all pre-disease performance without restriction) to 5 (patient is dead).

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Grade 0	BG00097 BG001

Alcohol consumption

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
None	BG000160 BG001145 BG002

Tobacco consumption

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
non-smoker	BG00081 BG00177 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Acute Phase

Posted

Count of Participants

Participants

0-24 hours

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000225 OG001215

Title

Denominators

Categories

Title	Measurements
	OG000186 OG001186

Secondary

Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Delayed Phase

Posted

Count of Participants

Participants

>24-120 hours

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, in the Overall Phase

Posted

Count of Participants

Participants

0-120 hours

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With no Emetic Episodes in the Acute Phase

Posted

Count of Participants

Participants

0-24 hours

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With no Emetic Episodes in the Delayed Phase

Posted

Count of Participants

Participants

>24-120 hours

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With no Emetic Episodes in the Overall Phase

Posted

Count of Participants

Participants

0-120 hours

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With no Rescue Medication in the Acute Phase

Posted

Count of Participants

Participants

0-24 hours

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With no Rescue Medication in the Delayed Phase

Posted

Count of Participants

Participants

>24-120 hours

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With no Rescue Medication in the Overall Phase

Posted

Count of Participants

Participants

0-120 hours

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	1	225	15	225	14	225
EG001	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	0	215	12	215	22	215

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Leukopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected225 at risk EG0011 affected215 at risk
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0002 affected225 at risk EG0013 affected215 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0002 affected225 at risk EG0010 affected215 at risk
Atrial flutter	Cardiac disorders	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Cardio-respiratory arrest	Cardiac disorders	Systematic Assessment	EG0001 affected225 at risk EG0011 affected215 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0002 affected225 at risk EG0010 affected215 at risk
Mesenteric vein thrombosis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0001 affected225 at risk EG0011 affected215 at risk
Asthenia	General disorders	Systematic Assessment	EG0002 affected225 at risk EG0011 affected215 at risk
Death	General disorders	Systematic Assessment	EG0000 affected225 at risk EG0012 affected215 at risk
Disease progression	General disorders	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Pain	General disorders	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0001 affected225 at risk EG0011 affected215 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0000 affected225 at risk EG0011 affected215 at risk
Brain contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Subdural haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Blood creatinine increased	Investigations	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Blood urea increased	Investigations	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
ECG signs of myocardial infarction	Investigations	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Epilepsy	Nervous system disorders	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Transient ischaemic attack	Nervous system disorders	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected225 at risk EG0011 affected215 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected225 at risk EG0011 affected215 at risk
Angioedema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected225 at risk EG0011 affected215 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0001 affected225 at risk EG0010 affected215 at risk

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D011812	Quinuclidines
D006572	Heterocyclic Compounds, Bridged-Ring
D006571	Heterocyclic Compounds
D007546	Isoquinolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated