Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-02 @ 4:54 PM
Study NCT ID:
NCT01260194
Status:
TERMINATED
Last Update Posted:
2016-11-02
First Post:
2010-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer
Sponsor:
Hoffmann-La Roche
Organization:
Study Overview
Official Title:
An Open-label, Multicentre Phase IV Study of Trastuzumab in Combination With the Standard Therapy (as Per Routine Clinical Practice) as First-line Therapy in Patients With HER2 Positive Metastatic Gastric Cancer
Status:
TERMINATED
Status Verified Date:
2016-11
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 open-label, multi-center study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction. Patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg Herceptin as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: