Ignite Creation Date:
2024-05-06 @ 12:17 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01530334
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2012-01-31
Brief Title:
Iressa Re-Challenge in Advanced NSCLC EGFR M Patients Who Responded to Gefitinib USed as 1st Line or Previous Treatment
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase II Open Label Multicentre Single Arm Study to Characterise the Efficacy Safety and Tolerability of Gefitinib 250 mg IRESSA as 3rd Line Treatment Re-challenge in Patients Who Have Epidermal Growth Factor Receptor EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer NSCLC and Who Responded to Gefitinib in 1st Line and Progressed After 2nd Line Chemotherapy
Status:
COMPLETED
Status Verified Date:
2016-01
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:
ICARUS
Brief Summary:
the primary objective is to characterise the impact of gefitinib on the Response Evaluation Criteria in Solid Tumours RECIST based assessments objective response rate ORR confirmed complete responseCR or partial response PR and disease control rate DCR confirmed complete responseCR or partial response PR or stable disease SD in patients with EGFR M NSCLC
Detailed Description:
A phase II Open Label Multicentre Single Arm Study to Characterise the Efficacy Safety and Tolerability of Gefitinib 250 mg IRESSA as 3rd line treatment re-challenge in Patients who have Epidermal Growth Factor Receptor EGFR Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer NSCLC and who responded to gefitinib in 1st line and progressed after 2nd line chemotherapy
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 |
|---|---|---|---|
| EUDRACT n 2011-005157-31 | None | None | None |