Ignite Creation Date:
2024-05-06 @ 1:53 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01922583
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2013-08-02
Brief Title:
AUY922 in Patient With Stage IV NSCLC
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Multi-center Phase II Study of AUY922 in Patients With Stage IV Non-small Cell Lung Cancer NSCLC With Driver Molecular Alterations Other Than Sensitive EGFR Mutation Who Have Progressed After One Line of Systemic Therapy
Status:
COMPLETED
Status Verified Date:
2017-02
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:
NSCLC
Brief Summary:
This is an open-label single-arm multicenter phase II trial in patients with stage IV EGFR T790M EGFR exon 20 and other uncommon HER2 or BRAF-mutated ALK ROS1 or RET-rearranged NSCLC
Detailed Description:
Study Design
This is an open-label single-arm multicenter phase II trial in patients with stage IV EGFR T790M EGFR exon 20 and other uncommon HER2 or BRAF-mutated ALK ROS1 or RET-rearranged NSCLC n 9 x 7
Objectives
Primary objectives
To define the objective response rate by RECIST 11 of AUY922 in patients with stage IV EGFR T790M EGFR exon 20 and other uncommon HER2 or BRAF-mutated ALK ROS1 or RET-rearranged NSCLC
Secondary objectives
1 To define the disease control rate complete response partial response stable disease 24 weeks of AUY922 in patients with stage IV EGFR T790M EGFR exon 20 and other uncommon HER2 or BRAF-mutated ALK ROS1 or RET-rearranged NSCLC 2 To determine the progression-free survival of AUY922 in patients with stage IV EGFR T790M EGFR exon 20 and other uncommon HER2 KRAS or BRAF-mutated ALK ROS1 or RET-rearranged NSCLC 3 To determine the overall survival of AUY922 in patients with stage IV EGFR T790M EGFR exon 20 and other uncommon HER2 KRAS or BRAF-mutated ALK ROS1 or RET-rearranged NSCLC
Exploratory Objectives
To study the pharmacodynamics of circulating tumor cells and plasma proteins
Planned number of subjects A total of 63 patients for the first stage of this study in 1 - 3 centers in Taiwan
Patient population
1 Stage IV by AJCC 7th edition NSCLC
2 EGFR T790M mutation EGFR exon 20 and other uncommon mutation HER2 mutation BRAF mutation ALK translocation ROS1 translocation or RET translocation in tumor samples
3 One line of prior systemic therapy
This is an open-label single-arm multicenter phase II trial in patients with stage IV EGFR T790M EGFR exon 20 and other uncommon HER2 or BRAF-mutated ALK ROS1 or RET-rearranged NSCLC n 9 x 7
Objectives
Primary objectives
To define the objective response rate by RECIST 11 of AUY922 in patients with stage IV EGFR T790M EGFR exon 20 and other uncommon HER2 or BRAF-mutated ALK ROS1 or RET-rearranged NSCLC
Secondary objectives
1 To define the disease control rate complete response partial response stable disease 24 weeks of AUY922 in patients with stage IV EGFR T790M EGFR exon 20 and other uncommon HER2 or BRAF-mutated ALK ROS1 or RET-rearranged NSCLC 2 To determine the progression-free survival of AUY922 in patients with stage IV EGFR T790M EGFR exon 20 and other uncommon HER2 KRAS or BRAF-mutated ALK ROS1 or RET-rearranged NSCLC 3 To determine the overall survival of AUY922 in patients with stage IV EGFR T790M EGFR exon 20 and other uncommon HER2 KRAS or BRAF-mutated ALK ROS1 or RET-rearranged NSCLC
Exploratory Objectives
To study the pharmacodynamics of circulating tumor cells and plasma proteins
Planned number of subjects A total of 63 patients for the first stage of this study in 1 - 3 centers in Taiwan
Patient population
1 Stage IV by AJCC 7th edition NSCLC
2 EGFR T790M mutation EGFR exon 20 and other uncommon mutation HER2 mutation BRAF mutation ALK translocation ROS1 translocation or RET translocation in tumor samples
3 One line of prior systemic therapy
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1020009413 | OTHER | Taiwan Food and Drug Administration TFDA | None |