Last updated on February 2015

Phase I Study of Oral BAY 1217389 in Combination With Intravenous Paclitaxel

Are you eligible to participate in this study?

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

  • Conditions: Medical Oncology
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Male or female subjects aged >/= 18 years.
    Study population:
    For the dose-escalation cohorts: Subjects with histologically or cytologically
    confirmed advanced malignancies (solid tumors), refractory to any standard
    therapy, have no standard therapy available
    For the expansion cohort: Subjects with advanced, histologically or cytologically
    confirmed triple-negative breast cancer (TNBC), refractory to any standard
    therapy, have no standard therapy available, or subjects actively refused any
    tandard treatment and / or if, in the judgment of the investigator, experimental
    treatment is clinically acceptable.
    Subjects must have evaluable or measurable disease according to Response Evaluation
    Criteria In Solid Tumors (RECIST) 1.1.
    Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
    Life expectancy of at least 12 weeks.
    Adequate bone marrow, liver, and renal functions.

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

  • Known hypersensitivity to the study drugs or excipients of the preparations or any
    agent given in association with this study.
    Evidence of peripheral neuropathy of Grade >2.
    History of cardiac disease: congestive heart failure New York Heart Association (NYHA)
    class >II, unstable angina (anginal symptoms at rest), new-onset angina (within the
    past 3 months before study entry), myocardial infarction within the past 3 months
    before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta
    blockers, calcium channel blockers, and digoxin are permitted).
    Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic
    blood pressure >90 mmHg, despite optimal medical management.
    Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C.
    History of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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