A Phase 4 interventional study of Akynzeo and Standard of Care in Oncology, sponsored by VIFORFRANCE. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-06.
Sponsored by VIFORFRANCE (part of CSL Limited) · Phase 4, Interventional, and Supportive care
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
9,616 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 426 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →VIFORFRANCE is the lead sponsor of 6 studies on the registry; none are open to participants now.
First submitted before VIFORFRANCE became part of CSL Limited.
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Exclusion Criteria:
Drug: Akynzeo
Drug: Standard of Care
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
* 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
Anti-emetic response
Complete Response (no emetic episodes and no rescue medication) during overall phase for 1st cycle among patients with MEC non AC or AC chemotherapy regimen
Time frame: 1 cycle (cycle length is 28 days). Primary outcome will be assessed at the end of the chemotherapy cycle.
Plan to share: No
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This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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