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| Name | Class |
|---|---|
| JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd | UNKNOWN |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H PALO day 1 | Active Comparator | Highly Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1 |
|
| H PALO day 1,3,5 | Experimental | Highly Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5 |
|
| M PALO day 1 | Active Comparator | Moderately Emetogenic Arm, Palonosetron 0.25mg IV*1 dose on day 1 |
|
| M PALO day 1,3,5 | Experimental | Moderately Emetogenic Arm, Palonosetron 0.25mg IV*3 doses on days 1,3 and 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palonosetron Hydrochloride | Drug | 0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response rate | defined as no emetic episode and no use of rescue medication | 2-7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response rate | defined as no emetic episode and no use of rescue medication | 0-24 hours, 0-7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | China | |||
| Chinese Academy of Medical Sciences Cancer Hospital |
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| Palonosetron Hydrochloride | Drug | 0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent. |
|
| 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 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077924 | Palonosetron |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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