Chemotherapy-induced Nausea and Vomiting
Conditions
Brief summary
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.
Interventions
DRUGSP-01 (Granisetron Transdermal Delivery System)
SP-01 will be applied to the upper arm 24-48 hours before the start of chemotherapy, and left in place for 7 days.
DRUGGranisetron Hydrochloride Tablet
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.
Sponsors
Proswell Medical Corporation
Solasia Pharma K.K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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; * Peripheral Haematology: Hb ≥ 9.0 g/dL, absolute neutrophil count ≥ 1.5×10e9/L, platelet count ≥ 80×10e9/L * Blood biochemistry: Total bilirubin \< 1.25×ULN, ALT and AST ≤ 2.5×ULN; if liver metastasis, ALT and AST \< 5×ULN, Creatinine ≤ 1×ULN, basic normal serum electrolyte (Na, Ka, Cl, Ca) * Other important organs function normally * Subjects voluntarily participate and signed the informed consent form
Design outcomes
Primary
| Measure | 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 |
Countries
China
Outcome results
None listed