Overview

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

Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Solasia Pharma K.K.
Collaborator:
Proswell Medical Corporation
Treatments:
Granisetron
Criteria
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