Ignite Creation Date:
2024-05-06 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03403712
Status:
COMPLETED
Last Update Posted:
2020-06-01
First Post:
2018-01-04
Brief Title:
A Study to Assess the Safety and the Efficacy of IV FosnetupitantPalonosetron 260 mg025 mg Combination Compared to Oral NetupitantPalonosetron 300 mg05 mg Combination for the Prevention of CINV in AC Chemotherapy in Women With Breast Cancer
Sponsor:
Helsinn Healthcare SA
Organization:
Helsinn Healthcare SA
Study Overview
Official Title:
A Multicenter Randomized Double-blind Double-dummy Active-controlled Parallel Group Phase 3b Study to Assess the Safety and to Describe the Efficacy of IV FosnetupitantPalonosetron 260 mg025 mg Combination IV NEPA FDC Compared to Oral NetupitantPalonosetron 300 mg05 mg Combination Akynzeo for the Prevention of Chemotherapy-induced Nausea and Vomiting in Initial and Repeated Cycles of Anthracycline-cyclophosphamide AC Chemotherapy in Women With Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multicenter randomized double-blind double-dummy parallel group stratified study assessing the safety and describing the efficacy of a single dose of intravenous IV fosnetupitantpalonosetron 260 mg025 mg infusion test versus oral netupitantpalonosetron 300 mg05 mg combination control each administered with oral dexamethasone prior to initial and repeated cycles of AC chemotherapy in female breast cancer patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None