Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting
ESPNV
A Multi-center, Stratified Randomized, Controlled Study to Evaluate the Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in China
1 other identifier
interventional
599
1 country
18
Brief Summary
This purpose of this study is to evaluate the efficacy and safety of single and repeated doses of palonosetron hydrochloride in preventing nausea and vomiting caused by moderate and highly emetogenic chemotherapy in patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 28, 2011
CompletedFirst Posted
Study publicly available on registry
November 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedDecember 31, 2012
December 1, 2012
1.1 years
October 28, 2011
December 28, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Complete Response rate
defined as no emetic episode and no use of rescue medication
2-7 days
Secondary Outcomes (1)
Complete Response rate
0-24 hours, 0-7 days
Study Arms (4)
H PALO day 1
ACTIVE COMPARATORHighly Emetogenic Arm, Palonosetron 0.25mg IV\*1 dose on day 1
H PALO day 1,3,5
EXPERIMENTALHighly Emetogenic Arm, Palonosetron 0.25mg IV\*3 doses on days 1,3 and 5
M PALO day 1
ACTIVE COMPARATORModerately Emetogenic Arm, Palonosetron 0.25mg IV\*1 dose on day 1
M PALO day 1,3,5
EXPERIMENTALModerately Emetogenic Arm, Palonosetron 0.25mg IV\*3 doses on days 1,3 and 5
Interventions
0.25 mg IV\*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
Eligibility Criteria
You may qualify if:
- Patients candidates to a chemotherapy treatment, with histologically or cytologically confirmed malignant disease;
- The concrete chemotherapy plan does not limited, group I (Highly Emetogenic Chemotherapy), group II (Moderately Emetogenic Chemotherapy);
- Male or female aged 18-75 years, ECOG≤2, estimates survival time≥3 months;
- WBC≥3.0×109/L, ANC≥1.5×109/L, PLT≥80×109/L, total bilirubin≤1.5×ULN(Normal value upper limit), AST and ALT≤2.5×ULN(With transferability liver cancer≤5×ULN), Cr and BUN≤1.5×ULN, electrolyte and electrocardiogram are normal, conforms to the chemotherapy adaptation;
- Patients have been apart from the previous chemotherapy to finish above 2 weeks (including 2 weeks);
- Patients that voluntarily sign the consent form.
You may not qualify if:
- Pregnancy, or patients during breast feeding;
- Patients have accepted any radiotherapy during the experimental period;
- Gastric outlet or intestinal obstruction;
- Patients have serious heart diseases, liver kidney diseases, or metabolism function disorder;
- Patients have epilepsy, or have been used psychotropic drug and calm drug;
- Received any drugs with potential anti-emetic efficacy, or experienced any vomiting, nausea or retching in the 24 hours prior to chemotherapy;
- Patients with transferability brain tumor, have vomiting caused by skull high pressure, or can not speak sickness situation and adverse reactions by self;
- Patients have known hypersensitivity to 5-HT3 antagonists;
- Patients have chemotherapy contraindications;
- Patients are participating, or have participated in other Clinical studies of new drugs within 2 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Anhui Provincial Hospital
Hefei, Anhui, China
Chinese Academy of Medical Sciences Cancer Hospital
Beijing, Beijing Municipality, China
Chinese PLA 301 Hospital
Beijing, Beijing Municipality, China
Chinese PLA 307 Hospital
Beijing, Beijing Municipality, China
Chinese PLA Navy General Hospital
Beijing, Beijing Municipality, China
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, China
Guangxi Cancer Hospital
Nanning, Guangxi, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Nanjing General Hospital of Nanjing Military Command
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Fourth People's Hospital of Wuxi
Wuxi, Jiangsu, China
Shandong Cancer Hospital
Jinan, Shandong, China
Shandong Provincial Hospital
Jinan, Shandong, China
The Affiliated Hospital of Medical College Qingdao University
Qingdao, Shandong, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Shanghai Xinhua Hospital
Shanghai, Shanghai Municipality, China
Tangdu Hospital of Fourth Military Medical University
Xian, Shanxi, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 28, 2011
First Posted
November 30, 2011
Study Start
July 1, 2011
Primary Completion
August 1, 2012
Last Updated
December 31, 2012
Record last verified: 2012-12