Ignite Creation Date:
2024-05-06 @ 4:27 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04983407
Status:
TERMINATED
Last Update Posted:
2023-10-30
First Post:
2021-07-08
Brief Title:
Safety and Efficacy Study of AVB-S6-500 Batiraxcept in Patients With Advanced Pancreatic Adenocarcinoma
Sponsor:
Aravive Inc
Organization:
Aravive Inc
Study Overview
Official Title:
A Phase 1b2 Randomized Study of AVB-S6-500 Plus Nab-paclitaxel and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to business reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1b2 study of batiraxcept AVB-S6-500 designed to evaluate the safety and efficacy of batiraxcept in combination with nab-paclitaxel and gemcitabine in subjects with locally advanced recurrent or metastatic pancreatic adenocarcinoma as first line therapy The phase 1b portion of the study is open label and patients will receive batiraxcept nab-paclitaxel and gemcitabine The Phase 2 portion of the study is randomized 2-arm open-label study to compare efficacy and tolerability of batiraxcept nab-paclitaxel and gemcitabine versus nab-paclitaxel and gemcitabine as first line therapy
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