drugset / Trial / NCT04085393

Granisetron Extended Release Injection (GERSC) for the Prevention of Chemotherapy-induced Nausea and Vomiting

NCT04085393 ↗

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Chemotherapy-induced nausea and vomiting (CINV) adversely affects patients' quality of life and may affect patients' treatment decisions. The emetogenicity of the chemotherapy administered and specific patient characteristics such as female gender, age, and history of low alcohol intake can increase a patients' risk for CINV. GERSC is a new, subcutaneously (SC) administered polymeric formulation of Granisetron that was developed to provide slow, controlled, and sustained release of Granisetron to prevent both acute and delayed CINV associated with moderately emetic chemotherapy (MEC) and highly emetic chemotherapy (HEC)

Timeline

Start
2020-08-15
Primary completion
2020-08-15
Completion
2022-12-01

Outcome

Outcome not reported

Stopped: “sponsor withdrew study”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Granisetron Other / unclassified — —