NCT01481831

Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 599 (actual)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Group I (Highly Emetogenic Chemotherapy): Patients that accepted chemotherapy including Cisplatin≥50mg/m2, Carmustine\>250mg/m2, Cyclophosphamide\>1500mg/m2, Dacarbazine\>60mg/m2, Doxorubicin\>60mg/m2, Epirubicin\>90mg/m2, IFO≥10g/m2 or AC program. Group II (Moderately Emetogenic Chemotherapy): Patients that accepted chemotherapy including any dose of Carboplatin, Daunorubicin, Oaliplatin, Irinotecan, or Doxorubicin\<60mg/m2(not include liposomal doxorubicin), Epirubicin≤90mg/m2, Carmustine≤250mg/m2, Methotrexate≥250mg/m2, Cyclophosphamide≤1500mg/m2, Arabinoside\>200mg/m2, IFO\<10g/m2, Cisplatin≥50mg/m2. Total subjects: 1000, single dose of palonosetron group of 500 patients, repeated doses of palonosetron group of 500 patients. According to the study subjects receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy, subjects are stratified randomize.

Conditions

• Neoplasms
• Chemotherapy-Induced Nausea and Vomiting

Interventions

Type	Name	Description
DRUG	Palonosetron Hydrochloride	0.25 mg IV\*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
DRUG	Palonosetron Hydrochloride	0.25mg IV\*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-08-01
• First posted: 2011-11-30
• Last updated: 2012-12-31

Locations

18 sites across 1 country: China