Last updated on November 2015

Phase Ib Study of Anetumab Ravtansine in Combination With Pemetrexed and Cisplatin in Mesothelin-expressing Solid Tumors

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Medical Oncology | Non-Small Cell Lung Cancer | Lung Cancer | Mesothelioma
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Subjects may be male or female, and must be aged =/>18 years on the date of signing
    the informed consent form.
    Subjects must have histologically confirmed, unresectable, locally advanced or
    metastatic pleural or peritoneal predominantly (>50% of tumor component) epithelial
    mesothelioma or nonsquamous non-small-cell lung cancer (NSCLC). Both
    chemotherapy-naive and previously treated subjects will be eligible; however, newly
    diagnosed NSCLC subjects eligible for FDA-approved therapies should have received the
    ame before enrollment (e.g. subjects with epidermal growth factor receptor
    [EGFR]-mutated and anaplastic lymphoma kinase [ALK]-translocated NSCLC should have
    received FDA-approved targeted therapies).
    Subjects must have at least 1 measurable or evaluable tumor lesion according to RECIST
    1 (for nonsquamous NSCLC) or mRECIST (for epithelial pleural mesothelioma). Subjects
    with resected primary tumors who have documented metastases are eligible.
    Subjects must have a life expectancy of at least 12 weeks.
    Subjects must have ECOG (Eastern Cooperative Oncology Group performance Status of 0 or
    Subjects must have adequate bone marrow, liver, kidney, and coagulation functions.

You may not be eligible for this study if the following are true:

  • Subjects who have a previous or concurrent cancer that is distinct in primary site or
    histology from the cancer being evaluated in this study, or any previous cancer
    curatively treated >3 years before the start of study Treatment.
    Subjects who have a history or current evidence of bleeding disorder, i.e. any
    hemorrhage / bleeding event of CTCAE (Common Terminology Criteria for Adverse Events)
    Grade ≥2 within 4 weeks before the start of study Treatment.
    Subjects who have new or progressive brain or meningeal or spinal metastases.
    Subjects who have a history or current evidence of uncontrolled cardiovascular disease
    i.e. NYHA (New York Heart Association) Class III or IV.
    Subjects who have a history or current evidence of uncontrolled hypertension defined
    as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at
    creening despite optimal medical management.
    Subjects who have a history or current evidence of malignant biliary obstruction
    requiring biliary stent.
    Subjects who have had solid organ or bone marrow Transplantation.
    Subjects who have a history of hypersensitivity to any of the study drugs or their
    excipients, or a history of severe hypersensitivity to any other Antigen.
    Subjects who have a history of human immunodeficiency virus (HIV) infection or
    ubjects who have an active hepatitis B virus (HBV) or hepatitis C virus (HCV)
    infection requiring treatment.
    Subjects who have an active clinically serious infection of CTCAE Grade ≥2 or
    non-healing wound unrelated to the primary Tumor.
    Subjects who have received systemic cancer therapy, radiotherapy, investigational drug
    treatment outside of this study within 4 weeks before the start of study treatment,
    granulocyte colony stimulating factors, (G-CSF) or granulocyte macrophage-stimulating
    factors (GM-CSF), erythropoietin-stimulating agents within 3 weeks before the start of
    general screening, drugs with known renal toxicity and strong cytochrome P450 3A4
    (CYP3A4) inhibitors or strong CYP3A4 inducers within 2 weeks before the treatment.
    Subjects who have started oral or parenteral anticoagulation therapy within 2 weeks
    before the start of anetumab ravtansine until end of treatment visit.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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