Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC
|ClinicalTrials.gov Identifier: NCT02109653|
Recruitment Status : Withdrawn (Study never started - transferred to Array.)
First Posted : April 10, 2014
Last Update Posted : February 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: LGX818||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||November 2017|
Adult patients, with confirmed diagnosis of BRAF V600E mutant advanced or metastatic NSCLC who have progressed on or after at least one prior systemic anticancer therapy.
Oral LGX818 300mg daily
- Overall Response Rate (ORR) [ Time Frame: up to 24 weeks ]ORR per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by investigator
- Overall Response Rate (ORR) [ Time Frame: baseline, every 6 weeks up to 24 weeks ]ORR per RECIST 1.1 as assessed by by Blinded independent review committee (BIRC)
- Progression-Free Survival (PFS) [ Time Frame: baseline, every 6 weeks up to 24 weeks ]PFS determined by investigator and BIRC.
- Duration of Response (DOR) [ Time Frame: baseline, every 6 weeks up to 24 weeks ]DOR by investigator and BIRC assessments.
- Overall survival (OS) [ Time Frame: baseline, every 6 weeks up to 24 weeks ]Overall survival (OS)
- Safety Profile [ Time Frame: baseline, every 3 weeks up to 24 weeks ]Adverse events and laboratory abnormalities
- Disease Control Rate (DCR) [ Time Frame: baseline, every 6 weeks up to 24 weeks ]DCR by investigator and BIRC assessments.
- Pharmacokinetics profile [ Time Frame: baseline, every 3 weeks up to 18 weeks ]Plasma concentration-time profiles of encorafenib (LGX818).
- Concordance between the BRAF mutation status from investigational diagnostic test and the companion diagnostic assay [ Time Frame: screening, up to 24 weeks ]Concordance rate between BRAF mutation status obtained using the investigational diagnostic test and the companion diagnostic assay which will be submitted for Pre-market approval (PMA)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109653
|United States, Illinois|
|University of Chicago Medical Center SC-2|
|Chicago, Illinois, United States, 60546|
|Study Director:||Array BioPharma||303-381-6604|