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An Efficacy and Safety Study of Oral and Intravenous Palonosetron for the Prevention of Nausea and Vomiting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01363479
Recruitment Status : Completed
First Posted : June 1, 2011
Results First Posted : November 17, 2014
Last Update Posted : November 17, 2014
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Helsinn Healthcare SA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Chemotherapy-Induced Nausea and Vomiting
Interventions Drug: Oral palonosetron
Drug: I.V. palonosetron
Drug: Dexamethasone
Enrollment 743
Recruitment Details  
Pre-assignment Details A total of 743 patients were randomized (ITT population), 739 received study medications (oral or I.V. palonosetron plus dexamethasone, safety population), 738 received study medications (oral or I.V. palonosetron plus dexamethasone, safety population) and chemotherapy (FAS population)
Arm/Group Title Oral Palonosteron Plus Dexamethasone I.V. Palonosetron Plus Dexamethasone
Hide Arm/Group Description

Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.

Oral palonosetron

Dexamethasone

Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.

I.V. palonosetron

Dexamethasone

Period Title: Overall Study
Started 371 [1] 372 [1]
Completed 359 351
Not Completed 12 21
[1]
number of randomised patients
Arm/Group Title Oral Palonosteron Plus Dexamethasone I.V. Palonosetron Plus Dexamethasone Total
Hide Arm/Group Description

Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.

Oral palonosetron

Dexamethasone

Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.

I.V. palonosetron

Dexamethasone

Total of all reporting groups
Overall Number of Baseline Participants 370 369 739
Hide Baseline Analysis Population Description
Safety population ie patients receiving either oral or IV palonosetron plus dexamethasone
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 370 participants 369 participants 739 participants
58.0  (9.41) 57.7  (9.92) 57.9  (9.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 370 participants 369 participants 739 participants
Female
151
  40.8%
152
  41.2%
303
  41.0%
Male
219
  59.2%
217
  58.8%
436
  59.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 370 participants 369 participants 739 participants
White 321 320 641
Asian 49 47 96
Hispanic 0 1 1
Other 0 1 1
1.Primary Outcome
Title Proportion of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication
Hide Description [Not Specified]
Time Frame 0-24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set i.e. patients receiving study drugs and chemotherapy
Arm/Group Title Oral Palonosteron Plus Dexamethasone I.V. Palonosetron Plus Dexamethasone
Hide Arm/Group Description:

Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.

Oral palonosetron

Dexamethasone

Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.

I.V. palonosetron

Dexamethasone

Overall Number of Participants Analyzed 369 369
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of responders
89.4
(85.9 to 92.2)
86.2
(82.3 to 89.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Oral Palonosteron Plus Dexamethasone, I.V. Palonosetron Plus Dexamethasone
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The null hypothesis was rejected (and non inferiority of oral palonosetron 0.50 mg versus I.V. palonosetron 0.25 mg demonstrated), if the lower limit of the 2 sided 99% CI for the difference in proportion of patients with CR (risk difference) was greater (i.e., closer to zero) than 15%.Study had 90% power.
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 3.21
Confidence Interval (2-Sided) 99%
-2.74 to 9.17
Estimation Comments The risk difference and the 99% CI calculation were performed using a 2 sided stratum adjusted Cochran Mantel Haenszel (CMH) test including gender and region as strata.
2.Secondary Outcome
Title Proportion of Patients With no Emesis
Hide Description [Not Specified]
Time Frame 0-24 hours
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Proportion of Patients With no Rescue Medication
Hide Description [Not Specified]
Time Frame 0-24 hours
Outcome Measure Data Not Reported
Time Frame Period starting from the time of informed consent signature until 21 days post study drugs administration on Day 1.
Adverse Event Reporting Description Based on the medical judgment of the investigator, all non resolved, non serious AEs beyond this date could have been followed for an additional 14 days. At the end of this additional follow up period, all unresolved AEs were documented on the eCRF as “ongoing.”
 
Arm/Group Title Oral Palonosteron Plus Dexamethasone I.V. Palonosetron Plus Dexamethasone
Hide Arm/Group Description

Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.

Oral palonosetron

Dexamethasone

Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.

I.V. palonosetron

Dexamethasone

All-Cause Mortality
Oral Palonosteron Plus Dexamethasone I.V. Palonosetron Plus Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Oral Palonosteron Plus Dexamethasone I.V. Palonosetron Plus Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   36/370 (9.73%)   36/369 (9.76%) 
Blood and lymphatic system disorders     
Anemia * 1  1/370 (0.27%)  6/369 (1.63%) 
Febrile Neutropenia * 1  3/370 (0.81%)  4/369 (1.08%) 
Leucopenia * 1  1/370 (0.27%)  1/369 (0.27%) 
Neutropenia * 1  5/370 (1.35%)  9/369 (2.44%) 
Pancytopenia * 1  1/370 (0.27%)  0/369 (0.00%) 
Thrombocytopenia * 1  2/370 (0.54%)  5/369 (1.36%) 
Cardiac disorders     
Acute Myocardial Infarction * 1  0/370 (0.00%)  1/369 (0.27%) 
Angina unstable * 1  0/370 (0.00%)  1/369 (0.27%) 
Arteriosclerosis coronary artery * 1  1/370 (0.27%)  0/369 (0.00%) 
Arteriospasm coronary * 1  0/370 (0.00%)  1/369 (0.27%) 
Cardiac failure acute * 1  0/370 (0.00%)  2/369 (0.54%) 
Cardiopulmonary failure * 1  0/370 (0.00%)  1/369 (0.27%) 
Myocardial infarction * 1  1/370 (0.27%)  0/369 (0.00%) 
Myocardial ischaemia * 1  1/370 (0.27%)  0/369 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/370 (0.27%)  0/369 (0.00%) 
Aphagia * 1  1/370 (0.27%)  0/369 (0.00%) 
Constipation * 1  1/370 (0.27%)  0/369 (0.00%) 
Diarrhoea * 1  3/370 (0.81%)  0/369 (0.00%) 
Gastric haemorrhage * 1  0/370 (0.00%)  1/369 (0.27%) 
Gastric ulcer haemorrhage * 1  0/370 (0.00%)  1/369 (0.27%) 
Haematochezia * 1  0/370 (0.00%)  1/369 (0.27%) 
Inflammatory bowel disease * 1  1/370 (0.27%)  0/369 (0.00%) 
Intestinal obstruction * 1  0/370 (0.00%)  1/369 (0.27%) 
Nausea * 1  3/370 (0.81%)  1/369 (0.27%) 
Proctitis ulcerative * 1  1/370 (0.27%)  0/369 (0.00%) 
Stomatitis * 1  0/370 (0.00%)  1/369 (0.27%) 
Vomiting * 1  3/370 (0.81%)  2/369 (0.54%) 
General disorders     
Asthenia * 1  3/370 (0.81%)  1/369 (0.27%) 
Chest Pain * 1  0/370 (0.00%)  1/369 (0.27%) 
Death * 1  0/370 (0.00%)  4/369 (1.08%) 
Fatigue * 1  1/370 (0.27%)  0/369 (0.00%) 
General physical health deterioration * 1  0/370 (0.00%)  1/369 (0.27%) 
Malaise * 1  1/370 (0.27%)  0/369 (0.00%) 
Multi-organ failure * 1  1/370 (0.27%)  1/369 (0.27%) 
Hepatobiliary disorders     
Hepatic function abnormal * 1  0/370 (0.00%)  1/369 (0.27%) 
Infections and infestations     
Pneumonia * 1  3/370 (0.81%)  1/369 (0.27%) 
Injury, poisoning and procedural complications     
Ankle fracture * 1  1/370 (0.27%)  0/369 (0.00%) 
Concussion * 1  1/370 (0.27%)  0/369 (0.00%) 
Investigations     
Blood creatinine increased * 1  0/370 (0.00%)  1/369 (0.27%) 
C-reactive protein increased * 1  1/370 (0.27%)  0/369 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  1/370 (0.27%)  0/369 (0.00%) 
Hypokalaemia * 1  1/370 (0.27%)  0/369 (0.00%) 
Malnutrition * 1  0/370 (0.00%)  1/369 (0.27%) 
Tumour lysis syndrome * 1  2/370 (0.54%)  0/369 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness * 1  1/370 (0.27%)  0/369 (0.00%) 
Osteolysis * 1  1/370 (0.27%)  0/369 (0.00%) 
Pain in extremity * 1  1/370 (0.27%)  0/369 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain * 1  1/370 (0.27%)  1/369 (0.27%) 
Metastases to central nervous system * 1  1/370 (0.27%)  0/369 (0.00%) 
Tumour haemorrhage * 1  0/370 (0.00%)  1/369 (0.27%) 
Tumour pain * 1  0/370 (0.00%)  1/369 (0.27%) 
Nervous system disorders     
Cerebral infarction * 1  0/370 (0.00%)  1/369 (0.27%) 
Cerebrovascular accident * 1  1/370 (0.27%)  0/369 (0.00%) 
Ischaemic stroke * 1  2/370 (0.54%)  0/369 (0.00%) 
Loss of consciousness * 1  2/370 (0.54%)  0/369 (0.00%) 
Syncope * 1  0/370 (0.00%)  1/369 (0.27%) 
Renal and urinary disorders     
Renal failure * 1  0/370 (0.00%)  2/369 (0.54%) 
Renal failure acute * 1  1/370 (0.27%)  0/369 (0.00%) 
Renal Impairment * 1  0/370 (0.00%)  2/369 (0.54%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  1/370 (0.27%)  1/369 (0.27%) 
Haemoptysis * 1  2/370 (0.54%)  2/369 (0.54%) 
Hypoxia * 1  0/370 (0.00%)  1/369 (0.27%) 
Laryngotracheal oedema * 1  1/370 (0.27%)  0/369 (0.00%) 
Pulmonary embolism * 1  1/370 (0.27%)  0/369 (0.00%) 
Vascular disorders     
Circulatory collapse * 1  1/370 (0.27%)  0/369 (0.00%) 
Deep vein thrombosis * 1  1/370 (0.27%)  0/369 (0.00%) 
Femoral artery embolism * 1  0/370 (0.00%)  1/369 (0.27%) 
Hypertension * 1  1/370 (0.27%)  0/369 (0.00%) 
Hypotension * 1  0/370 (0.00%)  1/369 (0.27%) 
Shock haemorrhagic * 1  1/370 (0.27%)  0/369 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Oral Palonosteron Plus Dexamethasone I.V. Palonosetron Plus Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   168/370 (45.41%)   171/369 (46.34%) 
Blood and lymphatic system disorders     
Neutropenia * 1  21/370 (5.68%)  28/369 (7.59%) 
Gastrointestinal disorders     
Constipation * 1  23/370 (6.22%)  20/369 (5.42%) 
General disorders     
Asthenia * 1  31/370 (8.38%)  28/369 (7.59%) 
Investigations     
Investigations * 1  41/370 (11.08%)  45/369 (12.20%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  21/370 (5.68%)  11/369 (2.98%) 
Nervous system disorders     
Headache * 1  9/370 (2.43%)  21/369 (5.69%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic and mediastinal disorder * 1  22/370 (5.95%)  18/369 (4.88%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor and investigator(s) agree that no publications discussing trials' results will occur until release of final report. Sponsor has no objections if the investigators publish study results, however the investigator is requested to contact the sponsor before publishing, to prevent premature disclosure of data and is not intended as a restrictive measure concerning results or opinions of investigators.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marco Palmas MD, Head of Clinical Development
Organization: Helsinn Healthcare SA
Phone: +41919852121
EMail: marco.palmas@helsinn.com
Layout table for additonal information
Responsible Party: Helsinn Healthcare SA
ClinicalTrials.gov Identifier: NCT01363479    
Other Study ID Numbers: PALO-10-01
First Submitted: May 30, 2011
First Posted: June 1, 2011
Results First Submitted: November 6, 2014
Results First Posted: November 17, 2014
Last Update Posted: November 17, 2014