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

Solasia Pharma

Status and phase

Completed

Phase 3

Conditions

Chemotherapy-induced Nausea and Vomiting

Treatments

Drug: SP-01 (Granisetron Transdermal Delivery System)

Drug: Granisetron Hydrochloride Tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT01937156

SP-0103

Details and patient eligibility

About

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.

Enrollment

313 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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