LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma

• Status: Terminated
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of the Phase II CLGX818X2102 study is to assess the anti-tumor activity of LGX818 in combination with selected agents.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Array BioPharma

Criteria

Inclusion Criteria:

• locally advanced or metastatic melanoma

• confirmed BRAF V600 mutation

• patients naïve to a selective BRAF inhibitor

• fresh tumor biopsy at baseline, and patient agrees for a mandatory biopsy at the time of relapse

• life expectancy ≥ 3 months

• World Health Organization (WHO) Performance Status ≤ 2.

Exclusion Criteria:

• Previous treatment with RAF-inhibitor

• Symptomatic or untreated leptomeningeal disease

• Symptomatic brain metastases.

• Known acute or chronic pancreatitis

• Clinically significant cardiac disease

• AST/SGOT and ALT/SGPT > 2.5 x ULN, or > 5 x ULN if liver metastases are present

• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral interventional drug

• Previous or concurrent malignancy.

• Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation

Specific exclusion criteria for each treatment arm:

LGX818/MEK162:

History or current evidence of retinal disease History of Gilbert's syndrome.

LGX818/BKM120:

Patients with diabetes mellitus requiring insulin treatment Patient has mood disorders

LGX818/BGJ398:

History and/or current evidence of ectopic mineralization/ calcification Current evidence of corneal disorder/ keratopathy Patients with current evidence of endocrine alteration of calcium/phosphate homeostasis.

History of congenital long QT- syndrome and/or hypokalaemia CTCAE Grade ≥ 3 and/or magnesium levels below the clinically relevant lower limits before study entry.

Ionized (i) calcium (Ca) > ULN Serum inorganic phosphorus (Pi) > ULN

LGX818/LEE011 History of congenital long QT- syndrome and/or hypokalaemia CTCAE Grade ≥ 3 and/or magnesium levels below the clinically relevant lower limits before study entry.