Last updated on April 2016

Phase I Study of BAY1436032 in Isocitrate Dehydrogenase-1 (IDH1)-Mutant Advanced Solid Tumors

Are you eligible to participate in this study?

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

  • Conditions: All solid tumors | Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Male or female patients ≥ 18 years of age
    Patients with a histologically confirmed solid tumor:
    Tumor must harbor an IDH1-R132X mutation
    Disease must be evaluable as per RECIST 1.1 or RANO (for gliomas)
    Patients with advanced cancer who are refractory to, have demonstrated
    intolerance to, or have refused access to, available standard therapies
    Glioma patients must have completed chemoradiotherapy at least 12 weeks prior to
    creening and their baseline scan
    Patient must be able to provide a formalin-fixed and paraffin-embedded (FFPE) tumor
    tissue specimen prior to treatment. The specimen may have been taken at any time
    during the course of the disease and may be from the primary tumor or from a
    Patient must be able to take oral medication and comply with protocol procedures and
    cheduled visits
    Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
    Negative serum or urine pregnancy test must be obtained within 7 days prior to the
    first dose of study drug in women of childbearing potential. Negative results must be
    available prior to study drug administration
    Sexually active women and men of reproductive potential must agree to use highly
    effective contraception. This applies for the period between signing of the informed
    consent and 3 months after the last administration of study drug. These procedures
    hould be documented in source documents. The investigator or a designated associate
    is requested to advise the patient on how to achieve highly effective birth control.
    Highly effective contraception includes:
    Established use of oral, injected or implanted hormonal methods of contraception
    Placement of certain intrauterine devices (IUD) or intrauterine systems (IUS)
    Hysterectomy, or vasectomy of the partner (provided that partner is the sole
    exual partner of the woman of childbearing potential trial participant and that
    the vasectomized partner has received medical assessment of the surgical success)
    In addition, the use of condoms for patients or their partners is required
    Ability to understand and the willingness to sign a written informed consent. A signed
    informed consent, including consent for biomarker analyses, must be obtained prior to
    any study-specific procedures
    Adequate blood clotting as defined by international normalized ratio (INR) and
    activated partial thromboplastin time (aPTT) ≤ 1.5 times ULN (patients on
    anticoagulation with an agent such as Coumadin or heparin or Xarelto will be allowed
    to participate provided that no prior evidence of underlying abnormality in these
    parameters exists). For patients on warfarin, close monitoring of at least weekly
    evaluations will be performed until INR is stable based on a measurement at pre-dose,
    as defined by the local standard of care
    Adequate bone marrow, liver, and renal functions as assessed by the following
    laboratory requirements to be conducted within 7 days prior to the first dose of study
    Hemoglobin ≥ 9.0 g/dL;
    Absolute neutrophil count (ANC) ≥ 1.5x10^9/L;
    Platelet count ≥ 100x10^9/L;
    Total bilirubin ≤ 1.5 times the upper limit of normal (ULN). For intrahepatic
    cholangiocarcinoma (IHCC) patients only, total bilirubin ≤ 2.5 times ULN is
    Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times
    ULN (≤ 5 times ULN for patients with impaired liver function due primary tumor or
    metastatic disease);
    Estimated glomerular filtration rate (eGFR) ≥ 40 mL/min per 1.73 m^2 according to
    the Modification of Diet in Renal Disease Study Group (MDRD) formula.

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

  • Known hypersensitivity to the study drug or excipients of the preparation or any agent
    given in association with this study
    History of cardiac disease, including congestive heart failure of New York Heart
    Association (NYHA) class >II, unstable angina (anginal symptoms at rest) or new-onset
    angina (within 6 months prior to study entry), myocardial infarction within 6 months
    prior to study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy except
    for beta-blockers and digoxin; evidence for uncontrolled coronary artery disease (e.g.
    angina pectoris, myocardial infarction within 6 months prior to study entry, major
    regional wall motion abnormalities upon baseline echocardiography or multiple-gated
    acquisition [MUGA] scan). Patients with a pacemaker are also excluded
    Left ventricular ejection fraction (LVEF) < 40% as measured by echocardiography or
    MUGA scan performed at Screening
    Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg or diastolic
    blood pressure ≥ 100 mmHg, despite medical management
    Patients who have an active clinically significant infection of the National Cancer
    Institute Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 2
    Previous or coexisting cancer(s) distinct in primary site or histology from the cancer
    evaluated in this study EXCEPT:
    Appropriately treated cervical cancer in-situ, non-melanoma skin cancers, or
    uperficial bladder tumors (Ta and Tis);
    Any cancer that was curatively treated at least 3 years before entry into this
    Unresolved specific chronic toxicity of previous treatment of grade > 1 except for
    alopecia or hemoglobin ≤9.0 g/dL (or ≤5.6 mmol/L)
    Major surgery, significant trauma, wide-field radiotherapy, or therapy with monoclonal
    antibodies within 4 weeks before the first dose of study drug
    Treatment with investigational or approved anti-cancer drugs within 4 weeks before the
    tart of BAY1436032 treatment and during the study (glioma patients must have
    completed chemoradiotherapy at least 12 weeks prior to screening and their baseline
    can; see inclusion criteria #2)
    Pregnant women. Women of reproductive potential must have a negative serum or urine
    pregnancy test performed within 7 day
    Prior treatment with any therapy targeting mutant IDH1 (including BAY1436032)

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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