Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05434663
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-28
First Post:
2022-06-22
Brief Title:
Safety Study of Repeat Doses of SUSTOL in Adults
Sponsor:
Heron Therapeutics
Organization:
Heron Therapeutics
Study Overview
Official Title:
A Phase 4 Open-Label Safety Study of Repeat Doses of SUSTOL in Adult Subjects Receiving Chemotherapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-07
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:
This is a repeat-dose single-arm open-label study that will evaluate the potential impact of subject-reported injection-site reactions ISRs on activities of daily living ADL in adult subjects with cancer receiving SUSTOL granisetron extended-release injection for subcutaneous use for prevention of chemotherapy induced nausea and vomiting CINV for up to 4 sequential cycles of chemotherapy Moderately Emetogenic Chemotherapy MEC or Anthracycline and Cyclophosphamide AC combination regimen
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