drugset / Trial / NCT05434663

Safety Study of Repeat Doses of SUSTOL in Adults

NCT05434663

Phase 4 Unknown 300 enrolled Heron Therapeutics
NaSingle-groupOpen-labelPrevention

Summary

This is a repeat-dose, single-arm, open-label study that will evaluate the potential impact of subject-reported injection-site reactions (ISRs) on activities of daily living (ADL) in adult subjects with cancer receiving SUSTOL® (granisetron) extended-release injection, for subcutaneous use for prevention of chemotherapy induced nausea and vomiting (CINV) for up to 4 sequential cycles of chemotherapy (Moderately Emetogenic Chemotherapy \[MEC\] or Anthracycline and Cyclophosphamide \[AC\] combination regimen).

Timeline

Start
2022-07-06
Primary completion
2025-10
Completion
2025-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Granisetron Other / unclassified 10 mg Subcutaneous