Clinical Trials /

Nintedanib in Patients With Advanced Esophagogastric Cancer

NCT02234596

Description:

This is a phase II study of Nintedanib in patients with metastatic or recurrent esophagogastric cancer. The goal of the study is to evaluate the efficacy of Nintedanib, an orally available triple kinase inhibitor targeting the receptors of the vascular endothelial growth factor (VEGF), platelet derived growth factor (PDGF), and fibroblast growth factor (FGF) receptor pathways.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Carcinoma
  • Gastric Adenocarcinoma
  • Gastric Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

<span class="go-doc-concept go-doc-intervention">Nintedanib</span> in Patients With Advanced Esophagogastric Cancer

Title

  • Brief Title: Nintedanib in Patients With Advanced Esophagogastric Cancer
  • Official Title: Phase II Trial of Nintedanib in Patients With Advanced Esophagogastric Cancer
  • Clinical Trial IDs

    NCT ID: NCT02234596

    ORG ID: 14-094

    Trial Conditions

    Esophagogastric Adenocarcinoma

    Trial Interventions

    Drug Synonyms Arms
    Nintedanib Nintedanib

    Trial Purpose

    This is a phase II study of Nintedanib in patients with metastatic or recurrent
    esophagogastric cancer. The goal of the study is to evaluate the efficacy of Nintedanib, an
    orally available triple kinase inhibitor targeting the receptors of the vascular endothelial
    growth factor (VEGF), platelet derived growth factor (PDGF), and fibroblast growth factor
    (FGF) receptor pathways.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Nintedanib Experimental Nintedanib

    Eligibility Criteria

    Inclusion Criteria:

    - Pathologically or cytologically MSKCC confirmed esophagogastric adenocarcinoma.

    - Metastatic diseases measurable or evaluable on a CT or MRI scan according to RECIST
    1.1 criteria. Locally recurrent disease that is not amenable to potentially curative
    surgery or radiation therapy is also allowed. Lesions must be 10mm in size.
    Recurrent or metastatic disease within a prior radiation field is acceptable as long
    as the disease has progressed in the radiation field by RECIST criteria.

    - Patients are allowed to have had a maximum of 1 prior chemotherapy regimen for
    metastatic disease. Patients are allowed to have a maximum of two prior regimens if
    they previously received neoadjuvant/adjuvant chemotherapy or chemoradiotherapy for
    their initial localized disease.

    - Patients aged 18 years or older.

    - Life expectancy of at least 6 months.

    - Karnofsky Performance Status (KPS) performance score 70%.

    - Patients must be able to reliably take and swallow oral medications.

    - Patients with prior deep vein thrombosis (DVT) or pulmonary embolism (PE) currently
    on anticoagulation regimen will be permitted.

    - Adequate bone marrow, liver, and renal function as assessed by the following:

    - Hemoglobin 9.0 g/dL.

    - Absolute neutrophil count (ANC) 1,500/mm3.

    - Platelet count 100,000/mm3.

    - Total bilirubin within normal limits, 0-1 mg/dL.

    - AST and ALT< 1.5 times ULN. (For patients with liver involvement: AST and ALT 2.5
    ULN).

    - International normalized ratio (INR) < 2, prothrombin time (PT) < 20 sec, and partial
    thromboplastin time (PTT) < 55 sec .

    - Creatinine < 1.5 x the ULN or GFR<45 ml/min.

    Exclusion Criteria:

    - HER-2 positive esophagogastric cancer. Patients with unknown HER2 status are
    permitted.

    - Patients receiving any concurrent anticancer therapy or investigational agents with
    the intention of treating esophagogastric cancer. Last prior therapy must have been
    completed at least 2 weeks (14 days) prior to starting Nintedanib.

    - Concurrent radiotherapy is not permitted for disease progression on treatment on
    protocol. However, symptomatic treatment for pre-existing non-target lesions would be
    allowed with approval from the principal investigator.

    - Prior treatment with VEGFR inhibitor.

    - Brain metastases or leptomeningeal disease.

    - History of arterial thromboembolic (arterial blood clot) or hemorrhagic event with
    the exception of patients with pulmonary embolism stable on an anticoagulation
    regimen.

    - Patients with a cerebrovascular accident or transient ischemic attack within the past
    six months.

    - Patients on warfarin for any reason.

    - Patient with known pre-existing interstitial lung disease.

    - History or presence of clinically relevant cardiovascular abnormalities such as
    uncontrolled hypertension, congestive heart failure, New York Heart Association
    (NYHA) functional classification of 3, unstable angina or poorly controlled
    arrhythmia. Myocardial infarction within 6 month prior to the study entry.

    - Patients with history of proteinuria grade 2.

    - Women of childbearing potential (WOCBP), or men who are able to father a child,
    unwilling to use a medically acceptable method of contraception during the trial and
    for at least three months after the end of active therapy.

    - Women who are pregnant or breast-feeding. Persistence of clinically relevant therapy
    related toxicity from previous chemotherapy and/or radiotherapy. This does not
    include hemoglobin or other hematologic or laboratory criteria, as long as
    eligibility criteria are met

    - Other malignancies within the past 5 years other than non-melanoma superficial skin
    cancer or carcinoma in situ of the cervix.

    - Concurrent medical conditions or injury which may increase the risk of toxicity,
    including ongoing or active infection, history of significant bleeding disorder
    unrelated to cancer (congenital bleeding disorders, acquired bleeding disorders
    within one year), history of HIV-positive, or active or chronic hepatitis C and/or B
    infection.

    - Known or suspected active drug or alcohol abuse.

    - Gastrointestinal disorders or abnormalities that would interfere with absorption of
    the study drug. Patients who are unable to orally swallow the study medication.

    - Known hypersensitivity to trial drug.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    6-month progression-free survival (PFS)

    Secondary Outcome Measures

    objective response rate

    Toxicities

    Trial Keywords

    Nintedanib

    14-094