A Randomized Controlled Trial of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting

A Randomized, Active-control, Double-blind, Double-dummy, Parallel-group, Multi-center Study to Assess the Efficacy and Safety of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Moderately or Highly Emetogenic (ME or HE) Multi-day Chemotherapy

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.

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