Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229496
Status:
RECRUITING
Last Update Posted:
2024-01-29
First Post:
2024-01-09
Brief Title:
Dose Escalation and Dose Expansion Study of GAS in Subjects With Metastatic Pancreatic Adenocarcinoma
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
A Phase 1b Open-label Multicenter Dose Escalation and Dose Expansion Study of S-1 in Combination With Nab-paclitaxel and Gemcitabine GAS in Subjects With Metastatic Pancreatic Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-01
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:
GAS
Brief Summary:
A Phase 1b open-label multicenter dose escalation and dose expansion study of S-1 in combination with nab-paclitaxel and gemcitabine GAS in subjects with metastatic pancreatic adenocarcinoma This study is a dose escalation and dose expansion study with the objective to establish the MTD andor RP2D andor DLT of nab-paclitaxel and gemcitabine in combination with a body surface areaBSA-based dose of S-1 in subject with metastatic pancreatic adenocarcinoma
Detailed Description:
Pancreatic ductal adenocarcinoma PDAC is the seventh leading cause of cancer- related death worldwide as the second leading cause of cancer mortality in the United States by 2030 The overall 5-year survival rate is around 5 for advanced PDAC and 15-30 for resected PDAC While recent advances have emerged in precision medicine and immunotherapy in a variety of cancer types unfortunately these drugs are not applicable to most patients with PDAC To date polychemotherapy combinations remain the mainstay of systemic treatments for advanced PDAC Of note FOLFIRINOX is a triplet combination regimen while nab-Paclitaxel and gemcitabine is a doublet combination Both NALIRIFOX and FOLFIRINOX showed the same median OS with about 111 months from NAPOLI 3 and PRODIGE4 trials respectively demonstrating the biologically comparable anti-tumor effects On the other hand the median OS of 85 months of gemcitabine plus nab-paclitaxel raised the question-would it be possible to add the third active drug in this doublet combination to achieve more potential efficacy being comparable with triplet combination such as FOLFIRINOX or NALIRIFOX Therefore in this study the investigator aimed to investigate whether adding S-1 to nab-paclitaxel and gemcitabine as GAS regimen can be a potential triplet combination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None