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Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC

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ClinicalTrials.gov Identifier: NCT02109653
Recruitment Status : Withdrawn (Study never started - transferred to Array.)
First Posted : April 10, 2014
Last Update Posted : February 12, 2016
Sponsor:
Information provided by (Responsible Party):
Array BioPharma

Brief Summary:
This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or IV) BRAF V600 mutant NSCLC. Patients must have progressed on or after at least one previous systemic, anti-cancer therapy for locally advanced or metastatic NSCLC.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: LGX818 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Single Arm, Open-label, Multicenter, Study of Oral LGX818 in Patients With BRAF V600 Mutant, Advanced Non-small Cell Lung Cancer (NSCLC) That Have Progressed During or After at Least One Prior Chemotherapy
Study Start Date : June 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LGX818
Adult patients, with confirmed diagnosis of BRAF V600E mutant advanced or metastatic NSCLC who have progressed on or after at least one prior systemic anticancer therapy.
Drug: LGX818
Oral LGX818 300mg daily




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: up to 24 weeks ]
    ORR per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by investigator


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: baseline, every 6 weeks up to 24 weeks ]
    ORR per RECIST 1.1 as assessed by by Blinded independent review committee (BIRC)

  2. Progression-Free Survival (PFS) [ Time Frame: baseline, every 6 weeks up to 24 weeks ]
    PFS determined by investigator and BIRC.

  3. Duration of Response (DOR) [ Time Frame: baseline, every 6 weeks up to 24 weeks ]
    DOR by investigator and BIRC assessments.

  4. Overall survival (OS) [ Time Frame: baseline, every 6 weeks up to 24 weeks ]
    Overall survival (OS)

  5. Safety Profile [ Time Frame: baseline, every 3 weeks up to 24 weeks ]
    Adverse events and laboratory abnormalities

  6. Disease Control Rate (DCR) [ Time Frame: baseline, every 6 weeks up to 24 weeks ]
    DCR by investigator and BIRC assessments.

  7. Pharmacokinetics profile [ Time Frame: baseline, every 3 weeks up to 18 weeks ]
    Plasma concentration-time profiles of encorafenib (LGX818).

  8. Concordance between the BRAF mutation status from investigational diagnostic test and the companion diagnostic assay [ Time Frame: screening, up to 24 weeks ]
    Concordance rate between BRAF mutation status obtained using the investigational diagnostic test and the companion diagnostic assay which will be submitted for Pre-market approval (PMA)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of BRAF V600E mutation in tumor tissue
  • Histologically or cytologically confirmed diagnosis of Stage IIIB or IV NSCLC
  • At least one measurable lesion as defined by RECIST v1.1
  • Patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic NSCLC.
  • Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status 0-2

Exclusion Criteria:

  • Patients with symptomatic Central Nervous System (CNS) metastases
  • History of leptomeningeal metastases
  • Prior therapy with a BRAF inhibitor
  • Patients taking prohibited medication listed in the protocol
  • Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
  • Impaired cardiovascular function or clinically significant cardiovascular diseases
  • Pregnant or lactating women or woman of childbearing potential

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02109653


Locations
United States, Illinois
University of Chicago Medical Center SC-2
Chicago, Illinois, United States, 60546
Sponsors and Collaborators
Array BioPharma
Investigators
Study Director: Array BioPharma 303-381-6604

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT02109653     History of Changes
Other Study ID Numbers: CLGX818A2202
2013-005014-34 ( EudraCT Number )
First Posted: April 10, 2014    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016

Keywords provided by Array BioPharma:
NSCLC,
Non-Small Cell Lung Cancer,
BRAF V600,
LGX818

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms