Status:
TERMINATED
LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma
Lead Sponsor:
Array BioPharma
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary purpose of the Phase II CLGX818X2102 study is to assess the anti-tumor activity of LGX818 in combination with selected agents.
Detailed Description
This is a phase II two part multi-center, open-label study. Part I: LGX818 single agent treatment until progression Part II: Combination treatments of LGX818 + MEK162, or BKM120, or BGJ398, or INC280,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01820364
Start Date
November 1 2013
End Date
March 1 2015
Last Update
January 9 2017
Active Locations (6)
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1
Sarah Cannon Research Institute Onc Dept
Nashville, Tennessee, United States, 37203
2
Novartis Investigative Site
East Melbourne, Victoria, Australia, 3002
3
Novartis Investigative Site
Edmonton, Alberta, Canada, T6G 1Z2
4
Novartis Investigative Site
Heidelberg, Germany, 69120