Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-21 @ 9:25 PM
Study NCT ID:
NCT02251951
Status:
COMPLETED
Last Update Posted:
2015-10-08
First Post:
2014-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nab-Paclitaxel as Salvage Treatment in Locally Advanced or Metastatic Gastric Cancer
Sponsor:
Hellenic Oncology Research Group
Organization:
Study Overview
Official Title:
A Multicenter, Phase II, Single-Arm Clinical Trial of Nab-Paclitaxel as Salvage Treatment for Patients With Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal Junction.
Status:
COMPLETED
Status Verified Date:
2015-10
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:
The investigators propose to study the efficacy and safety of nab-Paclitaxel in a Phase II trial of patients with locally advanced or metastatic adenocarcinomas of the stomach and gastro-esophageal junction
Detailed Description:
Adenocarcinomas of the stomach or gastrointestinal junction refractory/resistant to 1st line chemotherapy are considered as an orphan disease with limited (if any) treatment options. The promising results of Nab-Paclitaxel derived from preclinical studies and from clinical trials conducted in breast cancer patients open the field to develop such therapeutic approaches in other cancers types usually treated with taxanes such as gastric and GEJ adenocarcinomas. We design a phase II study in order to evaluate the effect of nab-Paclitaxel as salvage treatment for patients with advanced cancer of the stomach and GEJ previously treated with the DCF regimen.
Study Oversight
Has Oversight DMC:
False
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?: