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BAY 94-9343 for Advanced Solid Tumors

Published: December 8, 2011

Eligibility Criteria

Inclusion Criteria:
  • Subjects are eligible for inclusion in the dose escalation part of the study if all of the following criteria are met:
    • All subjects must be greater than or equal to 18 years at the first screening examination / visit
    • ECOG Performance Status of 0 to 1
    • Life expectancy of at least 12 weeks
  • Subjects with advanced, histologically or cytologically confirmed solid tumors, refractory to any standard therapy, or have no standard therapy available
    • Radiographically or clinically evaluable tumor
    • Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements to be conducted within 14 days prior to start of first dose:
    • Hemoglobin greater than or equal to 9.0 g/dL
    • Absolute neutrophil count (ANC) greater than or equal to 1500/mm3
    • Platelet count greater than or equal to 100,000 /mm(3)
    • Total bilirubin less than or equal to 1.5 times the upper limit of normal
    • ALT and AST less than or equal to 2.5 x upper limit of normal (less than or equal to 5 x upper limit of normal for subjects with liver involvement)
    • INR and PTT less than or equal to 1.5 x ULN for subjects not undergoing anticoagulative treatment. Subjects undergoing anticoagulative treatment with eg. warfarin or heparin, which was initiated at least 4 weeks prior to the planned start of treatment in this study and which is well controlled with INR and PTT in therapeutic ranges, are eligible
    • Serum creatinine less than or equal to 1.5 times ULN and glomerular filtration rate (GFR) greater than or equal to 30
    • ml/min/1.73 m2, according to the MDRD (Modified Diet in Renal Disease) abbreviated formula.
    • Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of treatment
    • Men and women in this study must use adequate barrier birth control measures prior to, during the course of the study, and for 3 months after the last administration of BAY 94-9343. An adequate contraception for female subjects includes a hormonal contraception with implants or combined oral contraceptives, certain intrauterine devices, bilateral tubal ligation, hysterectomy, or vasectomy of the subject’s partner. In addition, the use of condoms for the subject’s partners is required (exception: vasectomy of the subject’s partner). An adequate contraception for male subjects is vasectomy, or bilateral tubal ligation, or hysterectomy of the subject’s partner. Otherwise, the subject is required to use condoms and the subject’s partner an adequate contraception as described above.
    • Prior local radiotherapy is allowed if it is completed at least 3 weeks prior to the first dose of study drug and the subject has evaluable lesions not previously irradiated Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures Subjects are eligible for inclusion in the expansion part of the study, if all of the above described and one of the following criteria are met:
    • Subjects with confirmed histological or cytological diagnosis of
      1. Ovarian Carcinoma (epithelial tumors)
      2. Pancreatic Carcinoma (adeno carcinoma)
  • Subjects are to be excluded from the study if they display any of the following criteria:
    • Impaired cardiac function or clinically significant cardiac disease (ie, congestive heart failure (CHF) NYHA Class III or IV)
    • Myocardial infarction or onset of unstable angina < 3 months prior to screening
    • Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
    • LVEF < 40% (as measured at screening by MUGA or echocardiogram)
    • Uncontrolled hypertension defined as systolic blood pressure > 150 mm Hg and/or diastolic blood pressure > 90 mmHg, despite optimal medical management
    • History of symptomatic metastatic brain or meningeal tumors unless the subject is
  • > 3 months from definitive therapy and has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry. Subjects with brain metastases must not be undergoing acute corticosteroid therapy or steroid taper. Chronic steroid therapy is acceptable provided that the dose is stable for one month prior to screening
    • Subjects with CNS symptoms should undergo a CT scan or MRI of the brain to exclude new or progressive brain metastases. Spinal cord metastasis is acceptable
    • Subjects with severe renal impairment or on dialysis
    • Known human immunodeficiency virus (HIV) infection or subjects with an active hepatitis B or C infection requiring treatment. Subjects with chronic hepatitis B or C are eligible
    • Active clinically serious infections > CTCAE Grade 2
  • Serious, non-healing wound, ulcer, or bone fracture
    • Known or suspected allergy or intolerance to any agent given in the course of this trial
    • Previous cancer that is distinct in primary site or histology from actual disease and which was measurable or needed anticancer treatment within the last 5 years prior to screening.
  • Subjects with a history of cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumors [Ta and Tis] are eligible
    • Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study result
    • Major surgery, open biopsy, or significant trauma within 2 weeks prior to the planned start of study treatment
    • Anticancer chemotherapy, experimental cancer therapy, or immunotherapy within 2 weeks of start of first dose. Anticancer therapy is defined as any agent or combination of agents with clinically proven anti-tumor activity administered by any route with the purpose of affecting the malignancy, either directly or indirectly, including palliative and therapeutic endpoints. Toxic effects of previous anticancer chemotherapy, experimental cancer therapy, or immunotherapy have to be normalized completely (excluding alopecia)
    • Toxic effects considered as chronic, such as chemotherapy induced neuropathy of CTC
  • AE grade less than or equal to 2, where anymore resolution is not expected, does not prevent subjects from participation in the trial
    • Radiotherapy to the target lesions within 3 weeks prior to Day 1, Cycle 1 (first dose of study drug). (Palliative radiotherapy will be allowed). Radiotherapy to the target lesions during study will be regarded as progressive disease
    • Autologous or allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to first dose of study drug
    • Biological response modifiers, such as G-CSF, within 3 weeks of study entry. Subjects taking chronic erythropoietin (EPO) are permitted provided no dose adjustment is made within 2 months prior to start of first dose
    • Subjects who pregnant or are breast-feeding
    • Subjects with arterial or venous thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or clinically relevant pulmonary embolism within 1 month before the start of study medication Use of strong inhibitors of p-gp (eg, ritonavir, cyclosporine, verapamil and dronedarone) is prohibited from Day -14 and for the duration of the study.
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