Clinical Trials /

A Study to Assess the Efficacy and Safety of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations

NCT02109016

Description:

The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor (FGF), vascular endothelial growth factor receptor (VEGF), or platelet derived growth factor (PDGF) related genetic alterations.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
  • Small Cell Lung Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

A Study to Assess the Efficacy and Safety of the <span class="go-doc-concept go-doc-biomarker">VEGFR</span>-<span class="go-doc-concept go-doc-biomarker">FGFR</span> Inhibitor, <span class="go-doc-concept go-doc-intervention">Lucitanib</span>, Given to Patients With Advanced/Metastatic <span class="go-doc-concept go-doc-disease">Lung Cancer</span> and FGF, <span class="go-doc-concept go-doc-intervention">VEGF</span>, or PDGF Related Genetic Alterations

Title

  • Brief Title: A Study to Assess the Efficacy and Safety of the VEGFR-FGFR Inhibitor, Lucitanib, Given to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations
  • Official Title: A Single Arm, Open-label, Phase 2 Study to Assess the Efficacy and Safety of Lucitanib Given Orally as a Single Agent to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations
  • Clinical Trial IDs

    NCT ID: NCT02109016

    ORG ID: E-3810-II-02

    Trial Conditions

    SCLC

    Metastatic Lung Cancer

    Stage IV Lung Cancer

    Small Cell Lung Cancer

    Squamous Non-Small Cell Lung Cancer

    Advanced Lung Cancer

    Non-Small Cell Lung Cancer

    NSCLC

    Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    Lucitanib Lucitanib

    Trial Purpose

    The purpose of this study is to determine whether lucitanib is safe and effective in the
    treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor
    (FGF), vascular endothelial growth factor receptor (VEGF), or platelet derived growth factor
    (PDGF) related genetic alterations.

    Detailed Description

    Lucitanib is an oral inhibitor of the tyrosine kinase activity of FGFR 1-3, VEGFR 1-3, and
    PDGFR /. Lucitanib has demonstrated potent anti-tumor and anti-angiogenic activity in
    vitro proliferation assays and in vivo using human tumor xenograft models, with a trend for
    stronger efficacy in those with genomic aberrancies of FGF or PDGF. Abnormalities in the
    FGF, VEGF, and PDGF-related genes are observed across lung cancer histologies.

    The first in human trial of lucitanib demonstrated that 15 mg of lucitanib given daily is
    clinically active and tolerable in patients with advanced solid tumors. Specifically,
    patients with FGFR1-amplification appeared to derive particular benefit from lucitanib.

    Based on these results, this study is designed to explore the safety and anti-tumor activity
    of 15 mg of lucitanib daily in lung cancer patients with FGF, VEGF, and PDGF genetic
    alterations.

    Trial Arms

    Name Type Description Interventions
    Lucitanib Experimental Lucitanib given orally once daily on a continuous schedule. Starting dose 15 mg/day. Lucitanib

    Eligibility Criteria

    Inclusion Criteria:

    - Histologically or cytologically confirmed advanced/metastatic SCLC or NSCLC

    - Any of the following tumor tissue based genetic alterations: FGFR1, FGFR2, FGFR3,
    VEGFA, or PDGFR amplification; Any FGFR1, FGFR2, or FGFR3 gene fusion; FGFR1, FGFR2,
    or FGFR3 activating mutation

    - Availability of tumor tissue sample suitable for the central confirmation of the
    genetic alteration and exploratory analyses

    - Eastern Cooperative Oncology Group (ECOG) of 0 or 1

    - Measurable disease per RECIST 1.1

    - Documented radiographic disease progression following at least one line of therapy in
    the advanced/metastatic setting

    Exclusion Criteria:

    - Tumors that are invading a major vessel; NSCLC tumors abutting to a major vessel

    - Uncontrolled hypertension, defined as SBP 140 mmHg and/or DBP 90 mmHg with
    optimized anti-hypertensive therapy

    - Uncontrolled hypothyroidism defined as serum thyroid stimulating hormone (TSH) higher
    than 5 mIU/mL while receiving appropriate thyroid hormone therapy

    - Symptomatic and/or untreated central nervous system metastases

    - Presence of another active cancer

    - Ongoing adverse events from surgery or prior anti-cancer therapies, including
    radiation, targeted, or cytotoxic therapies

    - Pregnant or breastfeeding women

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Objective Response Rate (ORR)

    Secondary Outcome Measures

    Clinical Benefit Rate (CBR)

    Progression-Free Survival (PFS)

    Duration of response (DOR)

    Duration of clinical benefit

    Overall Survival (OS)

    Tumor growth kinetics

    Incidence of adverse events (AEs), clinical laboratory abnormalities, and dose modifications

    PK parameters of lucitanib

    Pharmacogenomic analysis of inter-patients variation in gene encoding ADME involved proteins

    Pharmacodynamic (PD) evaluation of lucitanib profile

    Trial Keywords

    FGFR1 amplification

    FGF alteration

    VEGF alteration

    PDGF alteration

    Tyrosine kinase inhibitor

    VEGFR inhibitor

    FGFR inhibitor

    PDGFR inhibitor

    VEGFR-FGFR inhibitor