NCT03831633

Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients

A Pragmatic Randomized Study to Evaluate the Comparative Effectiveness of AKYNZEO® and Standard of Care (Including EMEND®) for the Prevention of Nausea and Vomiting (CINV) in Cancer Patients Receiving Moderately Emetogenic Chemotherapy in France.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 426 (estimated)
• Sponsor: VIFORFRANCE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pragmatic trial addresses the clinical gap through the generation of evidence on the comparative effectiveness between AKYNZEO® and Standard of Care (SoC, including EMEND®) in the real-life setting

Conditions

• Oncology

Interventions

Type	Name	Description
DRUG	Akynzeo	1 single oral dose of NEPA (capsule) on Day 1 to be administered approximately 1 hour prior chemotherapy (containing 300 mg netupitant and 0.5 mg palonosetron). \- Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4
DRUG	Standard of Care	* oral aprepitant 125mg (Day 1) and 80mg daily (on Day 2 and Day 3) * IV ondansetron 8 mg on Day 1 * Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4

Timeline

• Start date: 2018-09-19
• Primary completion: 2019-07-31
• Completion: 2019-07-31
• First posted: 2019-02-06
• Last updated: 2019-02-06

Locations

1 site across 1 country: France