Ignite Creation Date:
2024-05-06 @ 3:06 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04526470
Status:
RECRUITING
Last Update Posted:
2021-08-24
First Post:
2020-08-17
Brief Title:
Alpelisib and Paclitaxel in PIK3CA-altered Gastric Cancer
Sponsor:
Seoul National University Bundang Hospital
Organization:
Seoul National University Bundang Hospital
Study Overview
Official Title:
Phase IBII Study of Alpelisib in Combination With Paclitaxel in Patients With PIK3CA-altered MetastaticRecurrent Gastric Cancer
Status:
RECRUITING
Status Verified Date:
2021-08
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:
Alpelisib BYL719 is a PIK3CA-specific inhibitor which was developed by Novartis Basel Switzerland Our group conducted pre-clinical study of alpelisib in eight gastric cancer cell lines four PIK3CA wild-type SNU638 SNU668 SNU1 and SNU16 and four PIK3CA mutant SNU719 AGS SNU601 and MKN As a result alpelisib preferentially inhibited the growth of gastric cancer cells with PIK3CA mutations In addition alpelisib inhibited cell growth via G1 arrest and subsequently induces apoptosis in GC cells and this effect is more remarkable in cells harboring PIK3CA mutations Moreover alpelisib in combination with paclitaxel showed synergistic cytotoxic effects and significantly increased apoptosis compared with alpelisib or paclitaxel monotherapy in GC cells
The purpose of the study is to define the maximal tolerated dose MTD and recommended phase II dose RP2D of paclitaxel and alpelisib combination therapy in patients with advanced tumors and to evaluate the efficacy of paclitaxel and AZD8186 combination therapy as a second-line therapy in patients with advanced gastric cancer with PTEN aberrations This study is divided into Phase IB and Phase II
The purpose of the study is to define the maximal tolerated dose MTD and recommended phase II dose RP2D of paclitaxel and alpelisib combination therapy in patients with advanced tumors and to evaluate the efficacy of paclitaxel and AZD8186 combination therapy as a second-line therapy in patients with advanced gastric cancer with PTEN aberrations This study is divided into Phase IB and Phase II
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