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| Name | Class |
|---|---|
| Proswell Medical Corporation | INDUSTRY |
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The purpose of this study is to assess the efficacy and safety of SP-01 in chemotherapy-induced nausea and vomiting (CINV) associated with the administration of moderately or highly emetogenic (ME or HE) multi-day chemotherapy,which will provide scientific and reliable clinical data in the drug registration in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP-01 | Experimental |
| |
| Granisetron Hydrochloride Tablet | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SP-01 (Granisetron Transdermal Delivery System) | Drug | SP-01 will be applied to the upper arm 24-48 hours before the start of chemotherapy, and left in place for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving Complete Control (CC) of CINV from the first administration until 24 hour after the last administration of ME or HE multi-day chemotherapy | 7 days |
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Inclusion Criteria:
Male or female aged ≥ 18years
Histologically and/or cytologically confirmed cancer
The physical status score ECOG ≤ 2
Life expectancy of ≥3 months
Will receive multi-day ME/HE chemotherapy (≥2 days) with the emetogenic potential of level 3-5
In accordance with the indication of chemotherapy and basic requirements;
Subjects voluntarily participate and signed the informed consent form
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| Name | Affiliation | Role |
|---|---|---|
| Shukui Qin, MD | The 81st hospital of P.L.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 81st Hospital of P.L.A. | Nanjing | Jiangsu | 210002 | China |
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| Granisetron Hydrochloride Tablet | Drug | Granisetron hydrochloride 1 mg tablets will be administered 1 hour before administration of chemotherapy at the first time, then taken 12 hours after the first dose later; 2 mg/day bid, for ≥ 2 days. |
|
| ID | Term |
|---|---|
| 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 |
|---|---|
| D017829 | Granisetron |
| ID | Term |
|---|---|
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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