Signed informed consent prior to study specific procedures. Signed informed consent prior to the performance of any study-specific procedures, including fresh tumor biopsies. Signed informed consent/authorization is obtained prior to conducting any study-specific screening procedures. Signed written informed consent granted prior to initiation of any study-specific procedures. Provide signed, written informed consent prior to the initiation of any study-specific procedures The patient has signed informed consent prior to initiation of any study-specific procedures or treatment. Signed, informed consent must be obtained prior to any study specific procedures Have signed an informed document prior to any study-specific procedures or treatment Signed informed consent obtained prior to initiation of any study-specific procedures and treatment; Signed, informed consent must be obtained prior to any study specific procedures 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 Signed written informed consent granted prior to initiation of any study-specific procedures Signed informed consent prior to the start of any study specific procedures. Ability to understand and willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures Signed informed consent prior to the start of any study specific procedures. Signed informed consent before initiation of any study procedures. Signed informed consent prior to initiation of any study?specific procedure or treatment, including consent to provide blood samples for correlative studies and to obtain a tumor biopsy during the study The patient has signed informed consent prior to initiation of any study-specific procedures or treatment. The patient has signed informed consent prior to initiation of any study-specific procedures or treatment. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patients awareness and willingness to comply with the study requirements (inclusive of biopsies, one at baseline and if they qualify, one pre-randomization for part B) Signed informed consent prior to any protocol-specific procedures 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 The patient has signed informed consent prior to initiation of any study-specific procedures or treatment. 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 Signed, informed consent must be obtained prior to any study specific procedures Signed, informed consent must be obtained prior to any study specific procedures. Signed informed consent prior to the start of any study specific procedures. Signed, informed consent must be obtained prior to any study specific procedures. Signed written informed consent granted prior to initiation of any study-specific procedures Have signed an informed document prior to any study-specific procedures or treatment 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 Ability to understand and willingness to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures 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. Have signed written informed consent prior to the initiation of any study-specific procedures A signed informed consent must be obtained prior to any study-specific procedures. Willing and able to sign a written informed consent; a signed informed consent must be obtained prior to any study specific procedures Ability to understand and to sign an informed consent form; a signed informed consent must be obtained prior to any study specific procedures 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 must give written informed consent to participate in study. Consent must be obtained prior to the performance of any study-specific, non-institutional standard procedures. A copy of the signed informed consent will be retained in the subject's chart. Documented, signed, dated informed consent obtained prior to any study specific procedures being performed Valid written informed consent signed by the patient prior to any study-specific procedures 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 Signed informed consent prior to any protocol-specific procedures