Ignite Creation Date:
2024-05-06 @ 12:50 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03862144
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2019-01-14
Brief Title:
NEPA to Prevent Chemotherapy Induced Nausea and Vomiting in Patients With Breast Cancer
Sponsor:
Consorzio Oncotech
Organization:
Consorzio Oncotech
Study Overview
Official Title:
One Day Antiemetic Prophylaxis of NEPA Netupitant Plus Palonosetron and Dexamethasone to Prevent Chemotherapy-induced Nausea and Vomiting CINV in Breast Cancer Patients Receiving an AC-based Chemotherapy Regimen
Status:
COMPLETED
Status Verified Date:
2019-03
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:
GIM15-NEPA
Brief Summary:
This study evaluates if the activity of one-day of NEPA plus dexamethasone to prevent chemotherapy-induced nausea and vomiting in breast cancer patients receiving adjuvant AC-based chemotherapy is maintained during all the chemotherapy cycle treatment maximum 4 cycles
Detailed Description:
Patients included in the study should be treated with the following antiemetic prophylaxis during all the AC-based chemotherapy cycles up to a maximum of 4 cycles
NEPA will be administered orally at the dose of 300 mg netupitant05 palonosetron 1 hour before the start of any chemotherapy cycle
Dexamethasone 12 mg will be added on day 1 only of each cycle
NEPA will be administered orally at the dose of 300 mg netupitant05 palonosetron 1 hour before the start of any chemotherapy cycle
Dexamethasone 12 mg will be added on day 1 only of each cycle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None