LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma
Stopped early · Phase 2
Conditions studied: Melanoma
In brief
The primary purpose of the Phase II CLGX818X2102 study is to assess the anti-tumor activity of LGX818 in combination with selected agents.
Key facts
- Study ID
- NCT01820364
- Run by
- Array BioPharma
- People needed
- 15
- Starts
- 2013-11-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2017-01-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Sarah Cannon Research Institute Onc Dept — Nashville, Tennessee, United States
- Novartis Investigative Site — East Melbourne, Victoria, Australia
- Novartis Investigative Site — Edmonton, Alberta, Canada
- Novartis Investigative Site — Heidelberg, Germany
- Novartis Investigative Site — Barcelona, Catalonia, Spain
- Novartis Investigative Site — Zurich, Switzerland
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.