Last updated on February 2020

Phase Ib Study of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin in Patients With Recurrent Mesothelin-expressing Platinum-resistant Cancer

Are you eligible to participate in this study?

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

  • Conditions: Recurrent Ovarian Cancer | Ovarian Cancer
  • Age: Between 18 - 100 Years
  • Gender: Female
  • Other:
    Subject must provide a signed informed consent before any screening procedures.
    Subject must be female and aged ≥18 years.
    Subject must have histologically confirmed, locally invasive or metastatic,
    predominantly epithelial platinum-resistant ovarian, fallopian tube, or primary
    peritoneal cancer.
    Subject must have recurrent, platinum-resistant cancer
    Subjects must provide samples of archival tumor tissue (tissue block or at least 5
    formalin-fixated, paraffin-embedded [FFPE] slides) at any time during the study.
    Subject must have a life expectancy of at least 12 weeks.
    Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of
    0 or 1.
    Subject must have adequate bone marrow, kidney and liver function and coagulation, as
    assessed by the standard laboratory test results
    Women of reproductive potential must have a negative serum beta human chorionic
    gonadotropin (beta HCG) pregnancy test obtained within 7 days before the start of
    anetumab ravtansine. Women not of reproductive potential are female subjects who are
    postmenopausal or permanently sterilized (e.g., tubal occlusion, hysterectomy,
    bilateral salpingectomy).
    Women of reproductive potential must agree to consistently use adequate contraception
    / birth control between signing of the informed consent and 60 days after the last
    administration of the last study drug. The investigator or a designated associate
    hould advise the subject how to achieve adequate contraception. Due to the lack of
    adequate reproductive toxicity data on anetumab ravtansine, subjects must
    concomitantly use 2 forms of adequate contraception.

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.
    Subjects who have a history or current evidence of bleeding disorder within 4 weeks
    before the start of anetumab ravtansine.
    Subjects who have new or progressive brain or meningeal or spinal metastases.
    Subjects who have QTc (QT interval corrected for heart rate) >480 ms, or heart rate
    >/=100 bpm, or LVEF (left ventricular ejection fraction) <50%, or a history or current
    evidence of uncontrolled cardiovascular disease.
    Women who are pregnant or breastfeeding.
    Subjects who had a major surgery or significant trauma within 4 weeks before the start
    of anetumab ravtansine.
    Subjects who have had organ allograft or hematopoietic transplantation.
    Subjects who have a history of hypersensitivity to any of the study drugs, or any
    other antigen.
    Subjects who have a history of human immunodeficiency virus (HIV) infection, or an
    active hepatitis B or C virus infection requiring treatment.
    Subjects with a non-healing serious wound, ulcer, or bone fracture unrelated to the
    primary tumor.
    Subjects with corneal epitheliopathy or any eye disorder that may predispose the
    ubjects to drug-induced corneal epitheliopathy.
    Subjects who have received systemic antitumor therapy or radiotherapy to target
    lesions within 4 weeks before the start of anetumab ravtansine
    Subjects who have unresolved CTCAE (Common Terminology Criteria for Adverse Events,
    v4.03) Grade >1 toxicity of previous anticancer therapy.
    Subjects who have received G-CSF (granulocyte colony-stimulating factor(s)), or GM-CSF
    (granulocyte macrophage-stimulating factor(s)), or erythropoietin-stimulating agents
    within 3 weeks before the start of screening.
    Subjects who have received chemotherapy with anthracycline agents at the cumulative
    dose of 550 mg/m2.
    Subjects who have received any investigational drug treatment outside of this study
    within 4 weeks before the start of anetumab ravtansine.
    Use of strong CYP3A4 inhibitors or strong CYP3A4 inducers oral or parenteral
    anticoagulation therapy started within 2 weeks before the start of anetumab ravtansine
    until the EoT (end of treatment) visit.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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