GX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma

• Conditions: ocally Advanced or Metastatic BRAF V600 Melanoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-004798-17-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-08
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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 major or equal to 3 Ionized (i) calcium (Ca) > ULN Serum inorganic phosphorus (Pi) > ULN or magnesium levels below the clinically relevant lower limits.

LGX818/LEE011:

History of congenital long QT- syndrome and/or hypokalaemia CTCAE Grade major or equal to 3 or magnesium levels below the clinically relevant lower limits.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified