Clinical Trials /

Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer

NCT01719380

Description:

This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Completed

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Study of <span class="go-doc-concept go-doc-intervention">LGX818</span> and <span class="go-doc-concept go-doc-intervention">Cetuximab</span> or <span class="go-doc-concept go-doc-intervention">LGX818</span>, <span class="go-doc-concept go-doc-intervention">BYL719</span>, and <span class="go-doc-concept go-doc-intervention">Cetuximab</span> in <span class="go-doc-concept go-doc-biomarker">BRAF</span> <span class="go-doc-concept go-doc-keyword">Mutant</span> Metastatic <span class="go-doc-concept go-doc-disease">Colorectal Cancer</span>

Title

  • Brief Title: Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer
  • Official Title: A Phase lb/II Multi-center, Open-label, Dose Escalation Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in Patients With BRAF Mutant Metastatic Colorectal Cancer
  • Clinical Trial IDs

    NCT ID: NCT01719380

    ORG ID: CLGX818X2103

    NCI ID: 2012-002138-35

    Trial Conditions

    Colorectal Cancer

    Trial Interventions

    Drug Synonyms Arms
    LGX818 LGX818 + cetuximab, LGX818 + BYL719 + cetuximab
    Cetuximab LGX818 + cetuximab, LGX818 + BYL719 + cetuximab
    BYL719 LGX818 + BYL719 + cetuximab

    Trial Purpose

    This study will assess the safety and efficacy of LGX818 when combined with cetuximab or
    combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    LGX818 + cetuximab Experimental LGX818, Cetuximab
    LGX818 + BYL719 + cetuximab Experimental LGX818, Cetuximab, BYL719

    Eligibility Criteria

    Inclusion Criteria:

    - Metastatic colorectal cancer

    - Progression after at least one prior standard of care regimen or be intolerant to
    irinotecan-based regimens

    - Life expectancy 3 months

    - ECOG performance status 2

    Exclusion Criteria:

    - Symptomatic or untreated leptomeningeal disease

    - Symptomatic brain metastasis

    - Patients with clinically manifested diabetes

    - Acute or chronic pancreatitis

    - Clinically significant cardiac disease

    Other protocol-defined inclusion/exclusion criteria may apply.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Incidence rate of dose-limiting toxicities

    Progression free survival

    Secondary Outcome Measures

    Incidence and severity of adverse events

    Plasma concentration

    Overall response rate

    Duration of response

    Time to response

    Progression free survival

    Overall survival

    Baseline molecular status of potential predictive markers of tumor response or resistance

    Trial Keywords

    Open-label dose escalation; BRAF inhibitor; LGX818; PI3K inhibitor; BYL719; EGFR; cetuximab; metastatic colorectal cancer; KRAS; BRAF; V600