Palonosetron

Generic Name: Palonosetron

Brand Names: Akynzeo, Aloxi, Palonosetron Accord

Drug Type: Small Molecule

Chemical Formula: C_₁₉H_₂₄N_₂O

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

Clinical Trials

Comparison of Palonosetron Versus Combination of Palonosetron and Dexamethasone for Preventing Postoperative Vomiting in Patients Receiving Fentanyl by Patient-controlled Analgesia After Minor Orthopedic Surgery

Not Applicable

Completed

Conditions: Orthopedic Surgery

Interventions: Drug: palonosetron with dexamethasone
Drug: palonosetron

First Posted Date: 2016-04-20

Last Posted Date: 2018-06-20

Lead Sponsor: Yonsei University

Target Recruit Count: 202

Registration Number: NCT02744508

Locations: 🇰🇷
Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Korea, Republic of

Study of the Effects of Intravenous Exenatide on Cardiac Repolarization

Phase 1

Completed

Conditions: Healthy Adult Male and Female Volunteers

Interventions: Drug: Placebo
Drug: Exenatide
Drug: Moxifloxacin
Drug: Palonosetron

First Posted Date: 2016-01-08

Last Posted Date: 2017-01-27

Lead Sponsor: Intarcia Therapeutics

Target Recruit Count: 82

Registration Number: NCT02650479

Locations: 🇳🇱
PRA-Groningen, Groningen, Netherlands

Effectiveness of Triple Therapy With Palonosetron for PON Prophylaxis

Phase 4

Completed

Conditions: Postoperative Nausea and Vomiting

Interventions: Drug: Palonosetron 0.075 mg IV
Drug: Dexamethasone 10 mg IV
Drug: Promethazine 25 mg IV

First Posted Date: 2015-12-21

Last Posted Date: 2017-05-05

Lead Sponsor: Ohio State University

Target Recruit Count: 40

Registration Number: NCT02635828

Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis

Not Applicable

Completed

Conditions: Postoperative Nausea and Vomiting

Interventions: Procedure: Automated recommendation at the start of the case
Procedure: Automated notification at the start of surgery
Procedure: Automated notification at the end of surgery
Device: Anesthesia Information Management System (AIMS)
Device: Perioperative Data Warehouse (PDW)
Procedure: General anesthesia
Procedure: Elective surgery
Drug: Propofol
Drug: Sevoflurane
Drug: Isoflurane
Drug: Desflurane
Drug: Scopolamine
Drug: Droperidol
Drug: Haloperidol
Drug: Dexamethasone
Drug: Promethazine
Drug: Meclizine
Drug: Aprepitant
Drug: Metoclopramide
Drug: Fentanyl
Drug: Sufentanil
Drug: Alfentanil
Drug: Remifentanil
Drug: Morphine
Drug: Meperidine
Drug: Hydromorphone
Drug: Methadone
Drug: Oxycodone
Drug: Oxymorphone
Drug: Hydrocodone
Drug: Ketamine
Drug: Ondansetron
Drug: Granisetron
Drug: Dolasetron mesylate
Drug: Palonosetron
Drug: Tropisetron
Drug: Ramosetron

First Posted Date: 2015-12-09

Last Posted Date: 2019-03-07

Lead Sponsor: Vanderbilt University

Target Recruit Count: 27034

Registration Number: NCT02625181

Locations: 🇺🇸
Vanderbilt University Medical Center, Nashville, Tennessee, United States

Postoperative Nausea and Vomiting: Ramosetron Plus Aprepitant vs Palonosetron Plus Aprepitant

Not Applicable

Completed

Conditions: Postoperative Nausea and Vomiting

Interventions: Drug: aprepitant
Drug: palonosetron
Drug: Ramosetron

First Posted Date: 2015-11-05

Last Posted Date: 2017-04-25

Lead Sponsor: Kyungpook National University Hospital

Target Recruit Count: 88

Registration Number: NCT02597907

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

Phase 3

Completed

Conditions: Chemotherapy-Induced Nausea and Vomiting

Interventions: Drug: Palonosetron
Drug: Dexamethasone

First Posted Date: 2015-09-22

Last Posted Date: 2018-06-20

Lead Sponsor: Helsinn Healthcare SA

Target Recruit Count: 441

Registration Number: NCT02557035

Locations: 🇧🇬
Specialized Hospital for Active Treatment in Oncology, Haskovo, Department of Medical Oncology, Haskovo, Bulgaria
🇧🇬
Multiprofile Hospital for Active Treatment "Central Onco Hospital", Plovdiv, Department of Medical Oncology, Plovdiv, Bulgaria
🇧🇬
Multiprofile Hospital for Active Treatment "Serdika", Sofia, Department of Medical Oncology, Sofia, Bulgaria

and more 71 locations