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

Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery

Not Applicable

Completed

Conditions: Laparoscopic Marsupialization of Renal Cyst

Interventions: Drug: Ondansetron
Drug: Normal saline inj
Drug: Ramosetron
Drug: Palonosetron

First Posted Date: 2010-07-26

Last Posted Date: 2011-11-18

Lead Sponsor: Yonsei University

Target Recruit Count: 105

Registration Number: NCT01169805

Locations: 🇰🇷
Severance Hospital, Yonsei University College of Medicine, Seoul, Korea, Republic of

Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Palonosetron in Cancer Treated With Chemotherapy

Phase 1

Completed

Conditions: Emesis

Interventions: Drug: Palonosetron

First Posted Date: 2010-01-11

Last Posted Date: 2015-01-27

Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Target Recruit Count: 29

Registration Number: NCT01046240

Locations: 🇪🇸
Clinica Universidad de Navarra, Pamplona, Navarra, Spain

Palonosetron Versus Ondansetron for the Prevention of Nausea and Vomiting

Phase 2

Completed

Conditions: Acute Myelogenous Leukemia
Chemotherapy-induced Nausea and Vomiting

Interventions: Drug: Palonosetron
Drug: Ondansetron

First Posted Date: 2009-12-14

Last Posted Date: 2012-08-07

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 150

Registration Number: NCT01031498

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States

Study With Palonosetron Alone in Preventing Chemotherapy-induced Nausea and Vomiting in Untreated Patients With Aggressive Non Hodgkin's Lymphomas Who Underwent Moderately Emetogenic Chemotherapy

Phase 2

Completed

Conditions: Chemotherapy-Induced Nausea and Vomiting
Non Hodgkin's Lymphoma

Interventions: Drug: Palonosetron

First Posted Date: 2009-11-25

Last Posted Date: 2009-11-25

Lead Sponsor: Gruppo Italiano Studio Linfomi

Target Recruit Count: 86

Registration Number: NCT01018758

Locations: 🇮🇹
Gruppo Italiano Studio Linfomi, Modena, Italy

Palonosetron for the Treatment of Nausea and Vomiting in Terminally Ill Patients

Phase 2

Terminated

Conditions: Nausea
Vomiting
Terminally Ill

Interventions: Drug: Palonosetron

First Posted Date: 2009-09-23

Last Posted Date: 2015-12-04

Lead Sponsor: University of Michigan Rogel Cancer Center

Target Recruit Count: 3

Registration Number: NCT00982995

Locations: 🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States

Pilot Study to Assess Palonosetron Versus Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU)

Phase 2

Completed

Conditions: Postoperative Nausea and Vomiting

Interventions: Drug: Ondansetron
Drug: Palonosetron

First Posted Date: 2009-08-28

Last Posted Date: 2021-01-11

Lead Sponsor: Eisai Inc.

Target Recruit Count: 239

Registration Number: NCT00967499

Locations: 🇺🇸
Precision Trials, Phoenix, Arizona, United States
🇺🇸
University of Miami, Miami, Florida, United States
🇺🇸
University of Kansas Medical Center, Kansas City, Kansas, United States

and more 5 locations

Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV

Phase 4

Completed

Conditions: PONV

Interventions: Drug: Palonosetron only
Drug: Palonosetron with Dexamethasone

First Posted Date: 2009-08-04

Last Posted Date: 2015-04-17

Lead Sponsor: NYU Langone Health

Target Recruit Count: 118

Registration Number: NCT00952133

Locations: 🇺🇸
NYU Langone Medical Center, New York, New York, United States

Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer

Phase 2

Terminated

Conditions: Anal Cancer
Carcinoma of the Appendix
Colorectal Cancer
Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Gastric Cancer
Gastrointestinal Carcinoid Tumor
Liver Cancer
Nausea and Vomiting
Pancreatic Cancer

Interventions: Drug: palonosetron hydrochloride
Other: placebo

First Posted Date: 2009-05-18

Last Posted Date: 2017-11-24

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 7

Registration Number: NCT00903396

Locations: 🇺🇸
Billings Clinic - Downtown, Billings, Montana, United States
🇺🇸
Bozeman Deaconess Cancer Center, Bozeman, Montana, United States
🇺🇸
Northern Montana Hospital, Havre, Montana, United States

and more 64 locations

Intravenous Palonosetron With Radiotherapy and Concomitant Temozolomide

Phase 2

Completed

Conditions: Malignant Glioma

Interventions: Drug: Palonosetron (PALO)

First Posted Date: 2009-05-13

Last Posted Date: 2019-08-28

Lead Sponsor: Duke University

Target Recruit Count: 57

Registration Number: NCT00900757

Locations: 🇺🇸
The Preston Robert Tisch Brain Tumor Center at Duke, Durham, North Carolina, United States

Fosaprepitant Dimeglumine, Palonosetron Hydrochloride, and Dexamethasone in Preventing Nausea and Vomiting Caused by Cisplatin in Patients With Stage III or Stage IV Head and Neck Cancer Undergoing Chemotherapy and Radiation Therapy

Phase 2

Terminated

Conditions: Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Nasopharynx
Nausea and Vomiting
Stage III Squamous Cell Carcinoma of the Larynx
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Oropharynx
Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Hypopharynx
Stage III Squamous Cell Carcinoma of the Nasopharynx
Stage IV Squamous Cell Carcinoma of the Larynx

Interventions: Drug: fosaprepitant dimeglumine
Drug: cisplatin
Drug: palonosetron hydrochloride
Drug: dexamethasone
Other: Functional Living Index-Emesis Questionnaire
Behavioral: Emesis Diary
Radiation: Radiotherapy

First Posted Date: 2009-05-08

Last Posted Date: 2017-05-18

Lead Sponsor: University of Washington

Target Recruit Count: 6

Registration Number: NCT00895245

Locations: 🇺🇸
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

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