Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy

Summary

Comparison of efficacy of APD403 at preventing delayed sickness in patients who have received cancer chemotherapy

Timeline

Start

2013-10

Primary completion

2015-02

Completion

2015-02

Outcome

Met primary endpoint

paper CR rate (24-120 h) was 20% with placebo and 46% with 10 mg amisulpride (p = 0.006 after multiplicity adjustment); PMID 30488222 ↗

paper Amisulpride 10 mg orally is safe and superior to placebo at preventing delayed CINV caused by highly emetogenic chemotherapy. PMID 30488222 ↗

Publications

• Herrstedt J, Summers Y, Jordan K, von Pawel J, Jakobsen AH, Ewertz M, Chan S, Naik JD, Karthaus M, Dubey S, Davis R, Fox GM. Amisulpride prevents nausea and vomiting associated with highly emetogenic chemotherapy: a randomised, double-blind, placebo-controlled, dose-ranging trial. Support Care Cancer. 2019 Jul;27(7):2699-2705. doi: 10.1007/s00520-018-4564-8. Epub 2018 Nov 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amisulpride	Small molecule	10 mg	Intravenous
Subject	Amisulpride	Small molecule	20 mg	Intravenous
Subject	Amisulpride	Small molecule	40 mg	Intravenous
Background	Dexamethasone	Small molecule	—	—
Background	Fosaprepitant	Other / unclassified	—	—
Background	Ondansetron	Other / unclassified	8 mg	Intravenous
Background	Ondansetron	Other / unclassified	16 mg	Intravenous

Indications

No indication recorded.