Safety and Efficacy of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting - Tabular View

Tracking Information

First Received Date ^ICMJE

July 16, 2007

Last Updated Date

January 5, 2008

Start Date ^ICMJE

April 2006

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting) [ Time Frame: 0-24h, 24-120h , 0-120h following chemotherapy ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00503386 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Major Protection from vomiting [ Time Frame: 0-24h,24-120h,0-120h following chemotherapy ]
Major Protection from nausea [ Time Frame: 0-24h,24-120h,0-120h following chemotherapy ]
Complete Protection from Both Vomiting and Nausea [ Time Frame: 0-24h,24-120h,0-120h following chemotherapy ]
Complete Protection from Both Vomiting and Moderate-to-Severe nausea [ Time Frame: 0-24h,24-120h,0-120h following chemotherapy ]
Time to First Emetic Episode [ Time Frame: 0-120h following chemotherapy ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase II,Multicenter,Randomized,Double-Blind,Cross-Over Study of Palonosetron Compared With Granisetron in Prevention of Chemotherapy-Induced Nausea and Vomiting in Asian Population

Brief Summary

The purpose of this study is to determine whether palonosetron is tolerate and effective in preventing chemotherapy-induced nausea and vomiting in oriental population. The study is comparing the safety and efficacy of palonosetron with granisetron, a frequently used antiemetic in China.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Nausea
Vomiting
Chemotherapy

Intervention ^ICMJE

Drug: Palonosetron
Drug: Granisetron

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

144

Completion Date

October 2006

Primary Completion Date

October 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or female, age ≥ 18 yrs and ＜70 yrs with histologically or cytologically confirmed
Malignant disease
Naive or nonnaive to chemotherapy, with a Karnofsky score of ≥ 60
Scheduled to receive two courses of moderately emetogenic chemotherapy or cisplatin 60 ~ 80 mg/m2 on study Day 1
Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit
Patients with hepatic, renal, or cardiovascular impairment eligible at the investigator's discretion
Patients experiencing, at maximum, mild nausea after previous chemotherapy eligible at the investigator's discretion
Predicted life expectancy of ≥ 3 months
Provision of written informed consent.

Exclusion Criteria:

Inability to understand or cooperate with study procedures
Receipt of investigational drugs ≤ 30 days before study entry
Receipt of other investigational drugs during the course of this study
Seizure disorder or any condition requiring anticonvulsants, sedatives
CNS malignancy or metastasis
Ongoing emesis due to obstruction of digestive tract
Emesis, retching, or Grade 2 or 3 nausea 24 hrs before chemotherapy
Moderate or severe nausea and vomiting after any previous chemotherapy
Scheduled receipt of any chemotherapeutic agent with an emetogenicity level ＞3 during study Days 2-5
Scheduled receipt of radiotherapy of the upper abdomen or cranium on study Days 2-5
Scheduled to receive any other drug with potential antiemetic efficacy within 24 h of study initiation and throughout day 5
Contraindications to 5-HT3 receptor antagonists
Contraindications to chemotherapy

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00503386

Responsible Party

Study ID Numbers ^ICMJE

HJGene_SYat-sen_06_01

Study Sponsor ^ICMJE

Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

Collaborators ^ICMJE

Sun Yat-sen University
Hangzhou Tigermed Consulting Co., Ltd.

Investigators ^ICMJE

Principal Investigator:

Tongyu Lin, M.D.

Sun Yat-sen University

Information Provided By

Hangzhou Jiuyuan Gene Engineering Co. Ltd.,

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP