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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

AMENO-2: Aprepitant Plus Palonosetron Versus Granisetron in the Prevention of Nausea and the Emesis Induced by Chemotherapy in Patients Treated With Haematopoietic Progenitors

Phase 4
Completed
Conditions
Leukemia
Lymphoma
Interventions
First Posted Date
2006-12-22
Last Posted Date
2009-09-18
Lead Sponsor
PETHEMA Foundation
Target Recruit Count
196
Registration Number
NCT00415103
Locations
🇪🇸

Hospital Universitario La Paz, Madrid, Spain

🇪🇸

Hospital Universitario Marqués de Valdecilla, Santander, Spain

🇪🇸

Hospital Universitario la Princesa, Madrid, Spain

and more 2 locations

Palonosetron for Prevention of Biochemotherapy Induced Nausea and Vomiting

Phase 1
Completed
Conditions
Melanoma
Interventions
First Posted Date
2006-12-18
Last Posted Date
2012-05-04
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
30
Registration Number
NCT00412425
Locations
🇺🇸

U.T. M.D. Anderson Cancer Center, Houston, Texas, United States

Palonosetron in Sarcoma Patients Receiving Chemotherapy With Adriamycin and Ifosfamide (AI)

First Posted Date
2006-12-13
Last Posted Date
2013-03-22
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
51
Registration Number
NCT00410488
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX

Phase 2
Completed
Conditions
Colorectal Cancer
Nausea and Vomiting
Interventions
First Posted Date
2006-09-28
Last Posted Date
2017-06-12
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
54
Registration Number
NCT00381862
Locations
🇺🇸

St. Josephs/Cander Hospital, Savannah, Georgia, United States

🇺🇸

Kaiser Permanente, Hilo, Hawaii, United States

🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

and more 3 locations

Comparative Study of Palonosetron With Granisetron as a Control in Patients Receiving Highly Emetogenic Chemotherapy

Phase 3
Completed
Conditions
Chemotherapy-Induced Nausea and Vomiting
Interventions
First Posted Date
2006-08-02
Last Posted Date
2011-07-07
Lead Sponsor
Taiho Pharmaceutical Co., Ltd.
Target Recruit Count
1140
Registration Number
NCT00359567
Locations
🇯🇵

National Cancer Center, 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan

Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer

Not Applicable
Completed
Conditions
Male Breast Cancer
Nausea and Vomiting
Stage IIIA Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer
Interventions
Procedure: quality-of-life assessment
Procedure: nausea and vomiting therapy
Procedure: management of therapy complications
Other: survey administration
First Posted Date
2006-06-23
Last Posted Date
2017-07-11
Lead Sponsor
University of Washington
Target Recruit Count
41
Registration Number
NCT00343863
Locations
🇺🇸

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, United States

APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

Phase 3
Completed
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Nausea and Vomiting
Interventions
First Posted Date
2006-06-23
Last Posted Date
2017-02-23
Lead Sponsor
Heron Therapeutics
Target Recruit Count
1428
Registration Number
NCT00343460
Locations
🇺🇸

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

🇺🇸

Palo Verde Hematology Oncology - Glendale, Glendale, Arizona, United States

🇺🇸

Eastern Connecticut Hematology and Oncology Associates, Norwich, Connecticut, United States

and more 49 locations

Safety and Efficacy Study for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving Stem Cell Transplantation.

Phase 2
Completed
Conditions
Multiple Myeloma
Interventions
First Posted Date
2006-03-24
Last Posted Date
2016-12-05
Lead Sponsor
Eisai Inc.
Target Recruit Count
75
Registration Number
NCT00306735
Locations
🇺🇸

Indiana Blood and Marrow Transplantation, Beech Grove, Indiana, United States

🇺🇸

Cornell Medical Center, New York, New York, United States

🇺🇸

Wake Forest Medical Center, Winston-Salem, North Carolina, United States

and more 7 locations
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