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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete Response rate
defined as no emetic episode and no use of rescue medication
2-7 days
No
China: Food and Drug Administration
zhiruo
NCT01481831
July 2011
Name | Location |
---|