Ignite Creation Date:
2025-12-17 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:40 AM
Study NCT ID:
NCT00758134
Status:
TERMINATED
Last Update Posted:
2013-05-29
First Post:
2008-09-22
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trastuzumab Therapy in Non-Small Cell Lung Cancer Patients
Sponsor:
Armando Santoro, MD
Organization:
Study Overview
Official Title:
Prospective Phase II Trial Evaluating Efficacy of Trastuzumab Therapy in HER2 FISH Positive and/or HER2 Mutation Positive, Pretreated, Non-Small Cell Lung Cancer Patients (MO20509)
Status:
TERMINATED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective study assessing efficacy of trastuzumab therapy in pretreated NSCLC patients. Patients with locally advanced or metastatic NSCLC, HER2 FISH positive and/or with HER2 gene mutation, pretreated with at least one previous chemotherapy line will be considered eligible for the trial. After evaluation of inclusion and exclusion criteria, and after signature of informed consensus form, all eligible patients will receive trastuzumab 6 mg/kg every 3 weeks (8 mg/kg loading dose) until disease progression, unacceptable toxicity or patient refusal.
Detailed Description:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2007-003709-29 | None | None | View |