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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01820364




Registration number
NCT01820364
Ethics application status
Date submitted
25/03/2013
Date registered
28/03/2013
Date last updated
9/01/2017

Titles & IDs
Public title
LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma
Scientific title
Phase II, Multi-center, Open-label Study of Single-agent LGX818 Followed by a Rational Combination With Agents After Progression on LGX818, in Adult Patients With Locally Advanced or Metastatic BRAF V600 Melanoma
Secondary ID [1] 0 0
2012-004798-17
Secondary ID [2] 0 0
CLGX818X2102
Universal Trial Number (UTN)
Trial acronym
LOGIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LGX818

Experimental: LGX818 single agent - Patients had to have written documentation of a BRAFV600 mutation, which was to have been obtained locally on a fresh tumor biopsy (preferred) or on the most recent archival tumor sample available.


Treatment: Drugs: LGX818
BRAF inhibitor. LGX818 was administered QD orally on a daily schedule (21-day cycles) as a flat-fixed dose and not by body weight or body surface area. LGX818 100 mg capsules and 50 mg capsules.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Tumor Response (Overall Response Rate) Per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I & Part II)
Timepoint [1] 0 0
Baseline through study completion (approximately 2 years)
Secondary outcome [1] 0 0
Incidence of Dose Limiting Toxicities (DLTs) (Part II)
Timepoint [1] 0 0
Baseline through study completion (approximately 2 years)
Secondary outcome [2] 0 0
Plasma Concentration and Derived Pharmacokinetic Parameters
Timepoint [2] 0 0
Baseline through study completion (approximately 2 years)
Secondary outcome [3] 0 0
Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I)
Timepoint [3] 0 0
Baseline through completion of Part I of the study (approximately 2 years)
Secondary outcome [4] 0 0
Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part II)
Timepoint [4] 0 0
Entry to Part II of the study through study completion (approximately 22 days)
Secondary outcome [5] 0 0
Molecular Status of Markers Relevant to the RAP/MEK/ERK and PI3K/AKT Pathways
Timepoint [5] 0 0
Baseline and at progression with LGX818 single agent treatment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2015
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Tennessee
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Germany
State/province [3] 0 0
Heidelberg
Country [4] 0 0
Spain
State/province [4] 0 0
Catalunya
Country [5] 0 0
Switzerland
State/province [5] 0 0
Zuerich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Array BioPharma
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01820364
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Array BioPharma
Address 0 0
303-381-6604
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01820364