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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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
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Secondary ID [1]
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2012-004798-17
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Secondary ID [2]
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CLGX818X2102
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Universal Trial Number (UTN)
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Trial acronym
LOGIC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Tumor Response (Overall Response Rate) Per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I & Part II)
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Assessment method [1]
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Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment.
The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment.
Per RECIST guidelines:
* Complete Response (CR) is the Disappearance of all target lesions.
* Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions.
* Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions.
* Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
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Timepoint [1]
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Baseline through study completion (approximately 2 years)
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Secondary outcome [1]
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Incidence of Dose Limiting Toxicities (DLTs) (Part II)
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Assessment method [1]
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Incidence of DLTs in Part II of the study was not evaluated due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study.
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Timepoint [1]
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Baseline through study completion (approximately 2 years)
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Secondary outcome [2]
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Plasma Concentration and Derived Pharmacokinetic Parameters
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Assessment method [2]
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Assessment of pharmacokinetic (PK) parameters and plasma concentration was not done due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study.
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Timepoint [2]
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Baseline through study completion (approximately 2 years)
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Secondary outcome [3]
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Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part I)
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Assessment method [3]
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Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment.
The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment.
Per RECIST guidelines:
* Complete Response (CR) is the Disappearance of all target lesions.
* Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions.
* Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions.
* Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
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Timepoint [3]
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Baseline through completion of Part I of the study (approximately 2 years)
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Secondary outcome [4]
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Tumor Response (Overall Response Rate) Via Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (Part II)
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Assessment method [4]
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Response Evaluation Criteria In Solid Tumors (RECIST) is a set of published rules that define the status of tumors in cancer patients during a specific treatment.
The Overall Response Rate was calculated according to the RECIST criteria, as per investigator assessment.
Per RECIST guidelines:
* Complete Response (CR) is the Disappearance of all target lesions.
* Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions.
* Progressive Disease (PD) is the at least a 20% increase in the sum of diameters of target lesions.
* Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
One patient with documented PD at study Day 146 entered into Part II of the study and received combination treatment of LGX818 450 mg plus MEK162 45 mg for two weeks. The patient experienced disease progression on Day 22 of Part II and discontinued the study.
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Timepoint [4]
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Entry to Part II of the study through study completion (approximately 22 days)
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Secondary outcome [5]
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Molecular Status of Markers Relevant to the RAP/MEK/ERK and PI3K/AKT Pathways
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Assessment method [5]
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Molecular status was not evaluated due to an inadequate number of patients enrolled in Part II prior to the permanent recruitment halt of this study.
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Timepoint [5]
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Baseline and at progression with LGX818 single agent treatment
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2015
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Sample size
Target
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigative Site - East Melbourne
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Recruitment postcode(s) [1]
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3002 - East Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Tennessee
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Country [2]
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Canada
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State/province [2]
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Alberta
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Country [3]
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Germany
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State/province [3]
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Heidelberg
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Country [4]
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Spain
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State/province [4]
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Catalunya
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Country [5]
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Switzerland
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State/province [5]
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Zuerich
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Array BioPharma
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01820364
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Array BioPharma
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Address
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303-381-6604
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01820364
Download to PDF