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

Phase 2

Completed

• Conditions: CINV
• Interventions: Drug: Ondansetron; Drug: Dexamethasone; Drug: Placebo; Drug: Fosaprepitant; Drug: APD403 IV; Drug: APD403 oral

• Registration Number: NCT01857232
• Lead Sponsor: Acacia Pharma Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-16
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-20
• Study Start: 2013-10
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Disposition First Submitted: 2016-07-28
• Disposition First Submitted QC: 2016-07-28
• Disposition First Posted: 2016-07-29
• Results First Submitted: 2018-11-27
• Results First Submitted QC: 2019-02-20
• Results First Posted: 2019-03-12
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 342

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Ondansetron	OND + DEX + FOS followed by oral DEX
Control	Dexamethasone	OND + DEX + FOS followed by oral DEX
Control	Fosaprepitant	OND + DEX + FOS followed by oral DEX
Placebo	Ondansetron	OND + APD403 followed by oral PLACEBO
Placebo	Placebo	OND + APD403 followed by oral PLACEBO
Placebo	APD403 IV	OND + APD403 followed by oral PLACEBO
Low dose APD403	Ondansetron	OND + APD403 followed by oral APD403 low dose
Low dose APD403	APD403 IV	OND + APD403 followed by oral APD403 low dose
Low dose APD403	APD403 oral	OND + APD403 followed by oral APD403 low dose
Mid dose APD403	Ondansetron	OND + APD403 followed by oral APD403 mid dose
Mid dose APD403	APD403 IV	OND + APD403 followed by oral APD403 mid dose
Mid dose APD403	APD403 oral	OND + APD403 followed by oral APD403 mid dose
High dose APD403	Ondansetron	OND + APD403 followed by oral APD403 high dose
High dose APD403	APD403 IV	OND + APD403 followed by oral APD403 high dose
High dose APD403	APD403 oral	OND + APD403 followed by oral APD403 high dose

Primary Outcome Measures

Name	Time	Method
Number of Participants With Delayed Phase Complete Response(CR)	24-120 hours	Delayed phase complete response (CR), defined as an absence of emetic episodes and no rescue medication use in the period from 24 to 120 hours after the initiation of chemotherapy.; The primary endpoint was analysed separately in the strata of chemotherapy regimen and gender, and in the strata of country.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With CR in the Overall Phase.	0 to 120 hours after the initiation of chemotherapy	CR defined as no emesis and no use of rescue medication, in the overall phase (0 to 120 hours after the initiation of chemotherapy)

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark