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Palonosetron

Generic Name
Palonosetron
Brand Names
Akynzeo, Aloxi, Palonosetron Accord
Drug Type
Small Molecule
Chemical Formula
C19H24N2O
CAS Number
135729-56-5
Unique Ingredient Identifier
5D06587D6R
Background

Palonosetron (INN, trade name Aloxi) is an antagonist of 5-HT3 receptors that is indicated for the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV). It is the most effective of the 5-HT3 antagonists in controlling delayed CINV nausea and vomiting that appear more than 24 hours after the first dose of a course of chemotherapy and is the only drug of its class approved for this use by the U.S. Food and Drug Administration. As of 2008, it is the most recent 5-HT3 antagonist to enter clinical use.

Indication

For the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy, as well as prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy. Also used for the prevention of postoperative nausea and vomiting for up to 24 hours post operation.

Associated Conditions
Nausea caused by Chemotherapy, Post Operative Nausea and Vomiting (PONV), Acute chemotherapy-induced nausea and vomiting, Delayed chemotherapy-induced nausea and vomiting

Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients

Phase 3
Completed
Conditions
Postoperative Nausea and Vomiting
Interventions
First Posted Date
2009-01-23
Last Posted Date
2015-04-03
Lead Sponsor
Helsinn Healthcare SA
Target Recruit Count
150
Registration Number
NCT00828295
Locations
🇷🇺

Federal State Institution St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the Federal Agency for High-Tech Medical Care, St. Petersburg, Russian Federation

🇷🇺

State Healthcare Institution 'Regional Pediatric Clinical Hospital', Yaroslavl, Russian Federation

🇺🇦

Cherkassy Regional Hospital, Pediatric Surgery Department, Cherkassy, Ukraine

and more 10 locations

Palonosetron Plus Dexamethasone in Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04594)

Phase 4
Completed
Conditions
Vomiting
Neoplasms
Nausea
Interventions
First Posted Date
2008-05-30
Last Posted Date
2017-05-15
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
118
Registration Number
NCT00687011

Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)

Phase 4
Completed
Conditions
Neoplasms
Nausea
Vomiting
Interventions
First Posted Date
2008-05-26
Last Posted Date
2017-05-16
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
59
Registration Number
NCT00684463

An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients

Phase 2
Completed
Conditions
Chemotherapy-Induced Nausea and Vomiting
Interventions
First Posted Date
2008-04-25
Last Posted Date
2008-04-25
Lead Sponsor
Xijing Hospital
Target Recruit Count
208
Registration Number
NCT00666783
Locations
🇨🇳

Xijng Hospital, Xi,an, Shaanxi, China

Palonosetron and Hydroxyzine to Reduce Opioid Withdrawal

Not Applicable
Completed
Conditions
Substance-Related Disorders
Interventions
First Posted Date
2008-04-18
Last Posted Date
2017-06-05
Lead Sponsor
Stanford University
Target Recruit Count
10
Registration Number
NCT00661674
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

Aloxi for Prevention of Chemotherapy Induced Nausea and Vomiting in Malignant Glioma Patients Receiving Irinotecan With Bevacizumab

Phase 2
Terminated
Conditions
Brain Cancer
Interventions
First Posted Date
2008-03-14
Last Posted Date
2014-04-01
Lead Sponsor
Duke University
Target Recruit Count
63
Registration Number
NCT00636805
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

Multi-day Doses in Prevention of Nausea and Emesis

Phase 2
Completed
Conditions
Myeloma, Plasma-Cell
Lymphoma, Malignant
Interventions
First Posted Date
2008-01-25
Last Posted Date
2017-03-09
Lead Sponsor
University of Kansas Medical Center
Target Recruit Count
20
Registration Number
NCT00600353
Locations
🇺🇸

University of Kansas Medical Center, Kansas City, Kansas, United States

Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer

Phase 3
Completed
Conditions
Chemotherapy-induced Nausea and Vomiting
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
First Posted Date
2007-11-04
Last Posted Date
2020-10-09
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
62
Registration Number
NCT00553059
Locations
🇺🇸

University of Texas M.D. Anderson, Houston, Texas, United States

🇺🇸

CCOP - Greenville, Greenville, South Carolina, United States

🇺🇸

Cancer Research for the Ozarks, Springfield, Missouri, United States

and more 1 locations

Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting

Phase 2
Completed
Conditions
Nausea
Vomiting
Chemotherapy
First Posted Date
2007-07-18
Last Posted Date
2010-09-17
Lead Sponsor
Hangzhou Jiuyuan Gene Engineering Co. Ltd.,
Target Recruit Count
144
Registration Number
NCT00503386
Locations
🇨🇳

Fujian Provincial Tumor Hospital, Fuzhou, Fujian, China

🇨🇳

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

🇨🇳

Jiangsu Provincial Tumor Hospital, Nanjing, Jiangsu, China

and more 3 locations

Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial

First Posted Date
2007-05-17
Last Posted Date
2015-11-10
Lead Sponsor
Joseph Roscoe
Target Recruit Count
1021
Registration Number
NCT00475085
Locations
🇺🇸

MBCCOP - Gulf Coast, Mobile, Alabama, United States

🇺🇸

CCOP - Central Illinois, Decatur, Illinois, United States

🇺🇸

CCOP - Kalamazoo, Kalamazoo, Michigan, United States

and more 13 locations
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