Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting
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
1 other identifier
interventional
144
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2006
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 16, 2007
CompletedFirst Posted
Study publicly available on registry
July 18, 2007
CompletedSeptember 17, 2010
September 1, 2010
6 months
July 16, 2007
September 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting)
0-24h, 24-120h , 0-120h following chemotherapy
Secondary Outcomes (5)
Major Protection from vomiting
0-24h,24-120h,0-120h following chemotherapy
Major Protection from nausea
0-24h,24-120h,0-120h following chemotherapy
Complete Protection from Both Vomiting and Nausea
0-24h,24-120h,0-120h following chemotherapy
Complete Protection from Both Vomiting and Moderate-to-Severe nausea
0-24h,24-120h,0-120h following chemotherapy
Time to First Emetic Episode
0-120h following chemotherapy
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hangzhou Jiuyuan Gene Engineering Co. Ltd.,lead
- Sun Yat-sen Universitycollaborator
- Tigermed Consulting Co., Ltdcollaborator
Study Sites (6)
Fujian Provincial Tumor Hospital
Fuzhou, Fujian, 350014, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Hunan Provincial Tumor Hospital
Changsha, Hunan, 410006, China
Jiangsu Provincial Tumor Hospital
Nanjing, Jiangsu, 210009, China
The Second Hospital Affiliated to Zhejiang University
Hangzhou, Zhejiang, 310009, China
Beijing Institute on Thoracic Cancer and Tuberculosis
Beijing, 101149, China
Related Publications (1)
Tian W, Wang Z, Zhou J, Zhang S, Wang J, Chen Q, Huang C, Pan L, Zhang L, Huang J, Shen H, Lin T. Randomized, double-blind, crossover study of palonosetron compared with granisetron for the prevention of chemotherapy-induced nausea and vomiting in a Chinese population. Med Oncol. 2011 Mar;28(1):71-8. doi: 10.1007/s12032-009-9398-2. Epub 2010 Jan 5.
PMID: 20049561DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tongyu Lin, M.D.
Sun Yat-sen University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 16, 2007
First Posted
July 18, 2007
Study Start
April 1, 2006
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
September 17, 2010
Record last verified: 2010-09