Ignite Creation Date:
2024-05-06 @ 2:42 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02109653
Status:
WITHDRAWN
Last Update Posted:
2020-11-13
First Post:
2014-03-25
Brief Title:
Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC
Sponsor:
Array Biopharma now a wholly owned subsidiary of Pfizer
Organization:
Array BioPharma
Study Overview
Official Title:
A Phase II Single Arm Open-label Multicenter Study of Oral LGX818 in Patients With BRAF V600 Mutant Advanced Non-small Cell Lung Cancer NSCLC That Have Progressed During or After at Least One Prior Chemotherapy
Status:
WITHDRAWN
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study never started - transferred to Array
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label multi-center single arm phase II study to evaluate the efficacy and safety of novel BRAF B-raf murine sarcoma viral oncogene homolog B1 inhibitor encorafenib LGX818 when used as single agent in patients with advanced or metastatic stage IIIB or IV BRAF V600 mutant NSCLC Patients must have progressed on or after at least one previous systemic anti-cancer therapy for locally advanced or metastatic NSCLC
Detailed Description:
None
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 |
|---|---|---|---|
| 2013-005014-34 | EUDRACT_NUMBER | None | None |