CLINICAL TRIALS PROFILE FOR ENCORAFENIB

All Clinical Trials for Encorafenib

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01777776 ↗	Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma.	Terminated	Array BioPharma	Phase 1/Phase 2	2013-07-01	To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.
NCT01820364 ↗	LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma	Terminated	Array BioPharma	Phase 2	2013-11-01	The primary purpose of the Phase II CLGX818X2102 study is to assess the anti-tumor activity of LGX818 in combination with selected agents.
NCT02109653 ↗	Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC	Withdrawn	Array BioPharma	Phase 2	2015-06-01	This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf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.
NCT02109653 ↗	Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC	Withdrawn	Array Biopharma, now a wholly owned subsidiary of Pfizer	Phase 2	2015-06-01	This is an open-label, multi-center, single arm phase II study to evaluate the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.
NCT02263898 ↗	Intermittent LGX818 and MEK162 in Treating Patients With Metastatic Melanoma Who Have BRAFV600 Mutations	Withdrawn	National Cancer Institute (NCI)	Phase 2	2015-01-01	This phase II trial studies intermittent dosing of BRAF inhibitor LGX818 (encorafenib) and MEK inhibitor MEK 162 (binimetinib) in treating patients with melanoma that has spread to other parts of the body (metastatic) and have a BRAF V600 mutation. LGX818 and MEK162 may stop the growth of tumor cells by blocking different enzymes needed for cell growth. Giving LGX818 and MEK162 with breaks between each course (intermittently) may help delay the time when tumors become resistant to the drugs.
NCT02263898 ↗	Intermittent LGX818 and MEK162 in Treating Patients With Metastatic Melanoma Who Have BRAFV600 Mutations	Withdrawn	Jonsson Comprehensive Cancer Center	Phase 2	2015-01-01	This phase II trial studies intermittent dosing of BRAF inhibitor LGX818 (encorafenib) and MEK inhibitor MEK 162 (binimetinib) in treating patients with melanoma that has spread to other parts of the body (metastatic) and have a BRAF V600 mutation. LGX818 and MEK162 may stop the growth of tumor cells by blocking different enzymes needed for cell growth. Giving LGX818 and MEK162 with breaks between each course (intermittently) may help delay the time when tumors become resistant to the drugs.
NCT02834364 ↗	BRAF/MEK Inhibition in Relapsed/Refractory Multiple Myeloma (BIRMA)	Active, not recruiting	Array BioPharma	Phase 2	2016-06-01	Trial for patients with refractory multiple myeloma after failure of at least two treatment regimens and with BRAFV600E/K Mutation to evaluate the efficacy of the kinase inhibitors Encorafenib (LGX818 in) combination with Binimetinib (MEK162).

Clinical Trial Conditions for Encorafenib

Condition Name

Condition Name for Encorafenib
Intervention	Trials
Melanoma	12
Metastatic Melanoma	8
Metastatic Colorectal Cancer	7
Colorectal Cancer	6

Condition MeSH

Condition MeSH for Encorafenib
Intervention	Trials
Melanoma	28
Colorectal Neoplasms	18
Neoplasms	7
Brain Neoplasms	7

Clinical Trial Locations for Encorafenib

Trials by Country

Trials by Country for Encorafenib
Location	Trials
United States	178
China	41
Italy	35
Spain	30
Germany	28

Trials by US State

Trials by US State for Encorafenib
Location	Trials
Texas	15
California	15
Tennessee	11
New York	11
Florida	9

Clinical Trial Progress for Encorafenib

Clinical Trial Phase

Clinical Trial Phase for Encorafenib
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Encorafenib
Clinical Trial Phase	Trials
Recruiting	37
Not yet recruiting	19
Active, not recruiting	6

Clinical Trial Sponsors for Encorafenib

Sponsor Name

Sponsor Name for Encorafenib
Sponsor	Trials
Pfizer	20
National Cancer Institute (NCI)	14
Array BioPharma	13

Sponsor Type

Sponsor Type for Encorafenib
Sponsor	Trials
Industry	81
Other	54
NIH	14