Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC
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|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Recruitment Status : Withdrawn (Study never started - transferred to Array.)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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|