Phase II Study of SyB D-0701 for Radiotherapy-Induced Nausea and Vomiting (RINV)

Summary

The purpose of this study is to explore the dose response of SyB D-0701 for preventing nausea and emesis associated with radiotherapy (fractionated/localized irradiation) in cancer patients scheduled to receive radiotherapy (fractionated/localized irradiation) alone.

Timeline

Start

2011-05

Primary completion

2012-10

Completion

2012-10

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Placebo Group vs SyB D-0701: High Dose Group; p = 0.2284; Fisher Exact NCT01700140 ↗

registry analysis (superiority or other test); Placebo Group vs SyB D-0701: Low Dose Group; p = 1.0000; Fisher Exact NCT01700140 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SyB D-0701	Unknown	18.75 mg	Other
Subject	SyB D-0701	Unknown	30 mg	Other

Indications