Within 2 weeks prior to registration: Subject has prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) test =< 1.3 x the laboratory upper limit of normal (ULN)Xx_NEWLINE_xXInternational normalized ratio of prothrombin time (INR) and prothrombin time (PT) must be =< 1.5 x ULN for the lab within 28 days before randomization; patients who are therapeutically treated with an agent such as warfarin may participate if they are on a stable dose and no underlying abnormality in coagulation parameters exists per medical historyXx_NEWLINE_xXProthrombin time (PT)/ international normalized ration (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULNXx_NEWLINE_xXPatients must have the following tests within 28 days prior to registration to obtain baseline measurements:\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR)/fibrinogen (all patients)\r\n* Neurologic assessmentXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.5 x ULNXx_NEWLINE_xXWithin 10 days of treatment initiation: Prothrombin time (PT) and partial thromboplastin time (aPTT) =< 1.5 X institutional upper limit of normal (IULN)Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x upper limit of normal (ULN); subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomizationXx_NEWLINE_xXCoagulation: International Normalized Ratio (INR) < 1.5 times normal, activated Partial Thromboplastin Time (aPTT) < 1.5 times normal. Patients receiving therapeutic doses of anticoagulant therapy may be considered eligible for the trial if INR and aPTT are within the acceptable therapeutic limits for the institution.Xx_NEWLINE_xXPT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULNXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.2 x ULNXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.2 X ULNXx_NEWLINE_xXPartial thromboplastin time (PTT) / prothrombin time (PT) =< 1.5 x ULN or international normalized ratio (INR) < 1.7 x ULN for patients who are not receiving therapeutic anticoagulation. Patients receiving therapeutic anticoagulation should be on a stable dose.Xx_NEWLINE_xXProthrombin time, international normalized ratio (INR), and/or activated partial thromboplastin time within =< 1.5 x ULN (for treatment phase)Xx_NEWLINE_xXObtained =< 21 days prior to registration: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN; NOTE: This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable doseXx_NEWLINE_xXActivated partial thromboplastin time (APTT) or partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x ULNXx_NEWLINE_xXAny of the following abnormal laboratory values (unless due to underlying lymphoma): International normalized ratio (INR) or prothrombin time (PT) >1.5*upper limit of normal (ULN) in the absence of therapeutic anticoagulation; partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) >1.5*ULN in the absence of a lupus anticoagulantXx_NEWLINE_xXPatients must have adequate coagulation function as evidenced by prothrombin time (PT), activated partial thromboplastin time (aPTT) and international normalized ratio (INR) within normal institutional limitsXx_NEWLINE_xXFOR SECOND-LINE THERAPY ONLY: Prothrombin time and partial thromboplastin time (PTT) must be =< 2 X the upper limit of the institution's normal range and INR (international normalized ratio) < 2; subjects on anticoagulation (such as coumadin) will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigatorXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) =< 2 times normal; timeline: within 3 weeks prior to enrollment orXx_NEWLINE_xXAdequate coagulation function as defined by international normalized ratio (INR) =< 1.5 and a partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal; patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparinXx_NEWLINE_xXInternational normalized ratio (INR) < 1.5; partial thromboplastin time (PTT) < 1.5 upper limit of normal (ULN); d-dimer < 250ng/mLXx_NEWLINE_xXPatients must have adequate coagulation (international normalized ratio (INR) or prothrombin time (PT), partial thromboplastin time (PTT) ?1.5 times ULN)Xx_NEWLINE_xXWithin 3 weeks prior to study registration: \r\nInternational normalized ratio (INR)/ partial thromboplastin time (PTT) =< 1.5 x ULN within 3 weeks prior to study registration; subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists ; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of careXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR)* =< 1.3 x upper limit of normal (ULN)\r\n* Subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization; PT and partial thromboplastin time (PTT) > 1.5 x ULN are permitted in these subjectsXx_NEWLINE_xXThe subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of cabozantinibXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN)Xx_NEWLINE_xXProthrombin time (PT) such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) < 1.2 times controlXx_NEWLINE_xXHas adequate blood clotting function, defined as: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN.Xx_NEWLINE_xXProthrombin time (PT) / partial thromboplastin time (PTT); PT such that international normalized ratio (INR) =< 1.5 x ULN (unless a patient is on therapeutic warfarin) or a PTT =< 1.5 x ULNXx_NEWLINE_xXInternational normalized ratio (INR) =< 1.5 and partial thromboplastin time (PPT) =< 5 seconds above the upper limit of normal (ULN)Xx_NEWLINE_xXProthrombin time (PT) such that the international normalized ratio (INR) is < 1.5 x ULN and activated partial thromboplastin time (aPTT) < 1.5 x ULN; prophylactic heparin or low molecular weight heparin (enoxaparin or alternative anticoagulants [other than warfarin]) are acceptableXx_NEWLINE_xXThe subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatmentXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.5 x institutional ULN (for participants on anticoagulation therapy, =< 1.5 x their baseline value)Xx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) ? 1.2 × ULN (unless receiving anticoagulation therapy, if receiving anticoagulation therapy, eligibility will be based upon international normalized ratio [INR]).Xx_NEWLINE_xXPartial thromboplastin (PT) or partial thromboplastin time (PTT) < 1.5 x institutional upper limitXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.5 x institutional ULN (for participants on anticoagulation therapy, =< 1.5 x their baseline value)Xx_NEWLINE_xXObtained within 28 days prior to registration: International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5Xx_NEWLINE_xXINCLUSION - PROCUREMENT: If pheresis required to collect blood\r\n* Prothrombin time (PT) and activated partial thromboplastin time (APTT) <1.5 × upper limit normalXx_NEWLINE_xXFor patients with planned deep tumor injections: prothrombin time (PT), activated partial thromboplastin time (aPPT), and international normalized ratio (INR) within normal limits; Platelet count ?100,000/?L; hemoglobin ? 9 gm/dL.Xx_NEWLINE_xXProthrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin and a partial thromboplastin time (PTT) =< upper limit of normalXx_NEWLINE_xXHematologic parameters for patients undergoing biopsy only: patients should have international normalized ratio (INR) =< 1.4 and partial thromboplastin time (PTT) =< 40 seconds (unless due to lupus anticoagulant); in patients not meeting these parameters, clearance by hematology will be required prior to undergoing a biopsyXx_NEWLINE_xXAdequate Coagulation defined as prothrombin time (PT) and partial thromboplastin time (PTT) <= 1.2 x upper limit of normal and an international normalized ratio (INR) <= 1.2.Xx_NEWLINE_xXThe participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatmentXx_NEWLINE_xXAdequate coagulation function, defined by prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT), or thrombin time (TT) of ?1.5 × ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULNXx_NEWLINE_xXInternational normalized ratio (INR) ? 1.5 and partial thromboplastin time (PTT) ? 1.5 x ULN. Prothrombin time (PT) may be used instead of INR if ? 1.5 x ULN.Xx_NEWLINE_xXFor participants not receiving therapeutic anticoagulation: International normalized ratio (INR) or activated partial thromboplastin time (aPTT) less than or equal to (</=) 1.5*upper limit of normal (ULN) within 28 days prior to initiation of study treatmentXx_NEWLINE_xXPT and PTT <1.5 x ULNXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) within normal limitsXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) (for patients on warfarin, INR should be maintained within therapeutic limits (either 2-3 or 2.5-3.5 for heart valve patients)Xx_NEWLINE_xXProthrombin time/International Normalized Ratio (PT/INR) < 1.5 x ULN and partial thromboplastin time (PTT) activated partial thromboplastin time (aPTT) < 1.5 x ULNXx_NEWLINE_xXPTT or activated partial thromboplastin time (aPTT) ?5 seconds above institutional ULNXx_NEWLINE_xXInternational normalized ratio (INR) ?1.5 or prothrombin time (PT) ?1.5 × ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) ?1.5 × ULN.Xx_NEWLINE_xXThe patient has adequate coagulation: prothrombin time (PT) and an International Normalized Ratio (INR), and partial thromboplastin time (PTT) ? 1.5 times the upper limit of normal (ULN),Xx_NEWLINE_xXInternational normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.5 x ULN (for patients on anticoagulation they must be receiving a stable dose for at least 1 week prior to enrollment)Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio and (PTT) in normal range ± 25%Xx_NEWLINE_xXPT and PTT w/in ?1.5× ULNXx_NEWLINE_xXInternational normalized ratio (INR)/ partial thromboplastin time (PTT) =< 1.5 x ULN; (subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of careXx_NEWLINE_xXPHASE I: Prothrombin time (PT) (or international normalized ratio [INR]) and partial thromboplastin time (PTT) =< 1.5 x ULNXx_NEWLINE_xXPHASE IB: PT (or INR) and PTT =< 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT) or international normalize rate (INR) within 1.5x upper limit of normal;Xx_NEWLINE_xXPartial thromboplastin time (PTT) within 1.5x upper limit of normal;Xx_NEWLINE_xXHematologic parameters for patients undergoing biopsy only: patients should have international normalized ratio (INR) =< 1.4 and partial thromboplastin time (PTT) =< 40 seconds (unless due to lupus anticoagulant); in patients not meeting these parameters, clearance by hematology will be required prior to undergoing a biopsyXx_NEWLINE_xXInternational normalized ratio (INR)/partial thromboplastin time (PTT) has to be =< 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 X upper limit of normal (ULN) unless receiving clinically indicated anticoagulant therapyXx_NEWLINE_xXProthrombin time (PT) or international normalized ratio (INR) and a partial thromboplastin time (PTT) > 1.5 times the upper limit of normalXx_NEWLINE_xXProthrombin time (PT/international normalized ratio [INR]) and activated partial thromboplastin time (aPTT) must be within 80 to 120% of the normal range at baselineXx_NEWLINE_xXPART I: Prothrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x the upper limits of normalXx_NEWLINE_xXInternational normalization ratio (INR) and activated partial thromboplastin time (aPTT) < 1.2 x ULNXx_NEWLINE_xXProthrombin Time (PT) and activated partial thromboplastin time (aPTT) <= 1.5x the upper limit of normal.Xx_NEWLINE_xXNormal prothrombin time (PT)Xx_NEWLINE_xXPartial thromboplastin time (PTT) at enrollment per institutional rangeXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) > 1.5 upper limit of normal (ULN)Xx_NEWLINE_xXSubject has prothrombin time/International Normalized Ratio or partial thromboplastin time test results at screening ?1.5 x ULN.Xx_NEWLINE_xXPartial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) less than 1.5 times normalXx_NEWLINE_xXWithin 7 days of enrollment and with 24 h of starting lymphodepleting chemotherapy: Prothrombin time (PT) & activated partial thromboplastin time (aPTT) =< 1.5 X ULN (correction with vitamin K allowed) unless subject is\r\nreceiving anticoagulant therapy (which should be managed according to institutional norms prior to and after excisional biopsy).Xx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT), partial thromboplastin time (PTT) =< 1.5 times upper limit of normalXx_NEWLINE_xXProthrombin time (PT) ?1.5 × ULN (Grade ?1).Xx_NEWLINE_xXActivated partial thromboplastin time (aPTT) ?1.5 × ULN (Grade ?1).Xx_NEWLINE_xXProthrombin time (PT) or international normalized ratio (INR), partial thromboplastin time (PTT) =< 1.5 x ULNXx_NEWLINE_xXWithin 28 days prior to administration of study treatment: Coagulation parameters (international normalized ratio [INR] and activated partial thromboplastin time [aPTT]) within 1.25 x ULN institutional limits, except where a lupus anti-coagulant has been confirmed, or except patients on anticoagulationXx_NEWLINE_xXAdequate coagulation function as defined by International Normalized Ratio ?1.5 or prothrombin time ?1.5 x ULN, and partial thromboplastin time ?1.5 x ULNXx_NEWLINE_xXActivated partial thromboplastin time (APTT) or partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXActivated partial thromboplastin time (aPTT), prothrombin time (PT) =< 1.2 x upper limit of normal (ULN)Xx_NEWLINE_xXCoagulation parameters: international normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULNXx_NEWLINE_xXProthrombin time (PT)/ international normalized ratio (INR), partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN)Xx_NEWLINE_xXActivated partial thromboplastin time/ partial thromboplastin time (aPTT/PTT) ? 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT)/ international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 28 days before the first dose of study treatment.Xx_NEWLINE_xXProthrombin time (PT) > 16.5 seconds orXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) > 35.9 secondsXx_NEWLINE_xXProthrombin time (PT) and/or prothrombin time international normalized ratio (PT-INR) and/or activated partial thromboplastin time (APTT) =< 1.3 x ULNXx_NEWLINE_xXInstitutional normalized ratio (INR) and partial thromboplastin time (aPTT) < 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test =< 1.5 x ULNXx_NEWLINE_xXInternational normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN if not on therapeutic anticoagulation; patients receiving therapeutic anticoagulation will be allowed if maintained on a stable dose within 14 days of study registrationXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) ? 1.5 times the ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN).Xx_NEWLINE_xXProthrombin time (PT) no more than 2 seconds above the upper limits of normal (ULN)Xx_NEWLINE_xXProthrombin time (PT)/institutional normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXInstitutional normalized ratio (INR) and partial thromboplastin time (aPTT) =< 1.5 x ULNXx_NEWLINE_xXPartial thromboplastin time (PTT)/activated (a)PTT =< 1.5 X institutional ULN normal except if, in the opinion of the investigator, the aPTT is elevated because of a positive lupus anticoagulant (unless dysfunction is secondary to lymphoma involvement)Xx_NEWLINE_xXWithin 7 days (+ 3 day window) of enrollment: Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x the institutional upper limit of normal (ULN), (this will not apply to subjects with confirmed Factor XII deficiency)Xx_NEWLINE_xXWithin 7 days before the first dose of study treatment: Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test < 1.3 x the ULN within 7 days before the first dose of study treatmentXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) must be =< 2 x the upper limit of the institution's normal range, at the time of enrollmentXx_NEWLINE_xXInternational normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN; this applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable doseXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder).Xx_NEWLINE_xXInternational normalized ratio (INR) and activated partial thromboplastin time (aPTT) > 1.5 x upper limit of normal (ULN) \r\n* This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable doseXx_NEWLINE_xXInternational normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN for patients who do not receive therapeutic anticoagulationXx_NEWLINE_xXThe subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory upper limit of normal (ULN) within 7 days before the first dose of study treatmentXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and activated partial thromboplastin time (aPTT) < 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder)Xx_NEWLINE_xXPerformed within 14 days of treatment initiation: International normalized ratio (INR) or prothrombin time (PT)\r\nactivated partial thromboplastin time (aPTT) =< 1.5 X ULN; if on active anticoagulants prior to study treatment, levels must be within standard therapeutic ranges per investigatorXx_NEWLINE_xXInternational normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN within 7 days prior to study enrollmentXx_NEWLINE_xXWithin 14 days of the first study treatment: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (for patients on anticoagulation they must be receiving a stable dose for at least 1 week prior to randomization)Xx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.5 X ULNXx_NEWLINE_xXWithin 14 days prior to cycle 1 day 1 of treatment: International normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin Time (aPTT) =< 1.5 x ULN (Note: This applies only to subjects who are not receiving therapeutic anticoagulation; subjects receiving therapeutic anticoagulation should be on a stable dose)Xx_NEWLINE_xXInternational normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULNXx_NEWLINE_xXPartial thromboplastin time (PTT) or activated PTT (aPTT) =< 1.5 x ULNXx_NEWLINE_xXInternational normalized ratio (INR) and activated partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN) provided the patient is not on anticoagulation therapyXx_NEWLINE_xXInternational normalized ratio (INR)/prothrombin time (PT), activated partial thromboplastin time (aPTT) =< 1.4 x ULN unless on therapeutic warfarin then INR/PT =< 3.5 obtained =< 14 days prior to registrationXx_NEWLINE_xXInternational normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN; unless patient is on therapeutic anticoagulationXx_NEWLINE_xXProthrombin time (PT) < 1.5Xx_NEWLINE_xXHepatic: Total bilirubin 1.5 x ULN; transaminases ? 2.5 x ULN (may be up to 5 x ULN if clearly due to liver metastases); prothrombin time (PT) and partial thromboplastin time (PTT) < 2 x (ULN).Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional upper limit of normal; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to alternate assignmentXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXInternational normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN; unless the patient is on therapeutic anticoagulation in which case the INR and aPTT must be within the therapeutic range of intended use of anti-coagulantsXx_NEWLINE_xXNormal PT/INR and PTT;Xx_NEWLINE_xXA Prothrombin Time (PT) or Partial Thromboplastin Time (PTT) within normal rangeXx_NEWLINE_xXProthrombin time/international normalized ratio (PT/INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULNXx_NEWLINE_xXProthrombin and partial thromboplastin times =< 1.2 x upper limit of normal (ULN) prior to biopsyXx_NEWLINE_xXInternational normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN; (subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists)Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXFULL STUDY INCLUSION CRITERIA: International normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN (Common Terminology Criteria for Adverse Events [CTCAE] grade =< 1)\r\n* Note: patients on stable dose of anti-coagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and INR / PT and partial thromboplastin time (PTT) / activated (a)PTT test results are compatible with the acceptable benefit-risk ratio at the investigator’s discretionXx_NEWLINE_xXFULL STUDY INCLUSION CRITERIA: Partial thromboplastin time (PTT) or activated PTT (aPTT) =< 1.5 x ULN (CTCAE grade =< 1)\r\n* Note: patients on stable dose of anti-coagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and INR / PT and PTT / aPTT test results are compatible with the acceptable benefit-risk ratio at the investigator’s discretionXx_NEWLINE_xXProthrombin time (PT) =< 1.5 x ULNXx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x ULNXx_NEWLINE_xXSerum coagulation studies (international normalized ratio [INR]/partial thromboplastin time [PTT]) and platelet counts suitable for surgery per surgeon discretionXx_NEWLINE_xXProthrombin time (PT)/ international normalized ratio (INR) and partial thromboplastin time (PTT) test =< 1.3 ULNXx_NEWLINE_xXProthrombin time (PT) or international normalized ratio (INR) or partial thromboplastin time ?1.5 x ULN. Patients on a stable, maintenance regimen of anticoagulant therapy for at least 30 days prior to study drug administration may have PT/INR measurements >1.5 x ULN if, in the opinion of the Investigator, the patient is suitable for the study. An adequate rationale must be provided to the Sponsor prior to randomization.Xx_NEWLINE_xXA prothrombin time (PT) or activated partial thromboplastin time (aPTT) above the ULN or a history of a coagulopathy or bleeding disorder.Xx_NEWLINE_xXProthrombin time (PT) and activated partial thromboplastin time (aPTT) levels ?1.5 x ULN. If institution does not report PT value, the international normalization ratio (INR) must be ? ULN.Xx_NEWLINE_xXActivated partial thromboplastin time (aPTT) within 1.25 x ULN institutional limits, except where a lupus anti-coagulant has been confirmedXx_NEWLINE_xXAbnormal coagulation parameters (prothrombin time [PT] > 15 seconds, partial thromboplastin time [PTT] > 40 seconds, and/or international normalized ratio [INR] > 1.5)Xx_NEWLINE_xXInternational normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (APTT) as follows: \r\n* In the absence of therapeutic intent to anticoagulate the patient: INR < 1.5 or PT < 1.5 x ULN or aPTT < 1.5 x ULN\r\n* In the presence of therapeutic intent to anticoagulate the patient: INR or PT and aPTT within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks before registrationXx_NEWLINE_xXObtained =< 14 days prior to registration: International normalized ratio (INR)/prothrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ration (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULNXx_NEWLINE_xXAcceptable coagulation status: international normalised ratio (INR) of blood clotting, prothrombin time and activated partial thromboplastin time within ?1.5 x upper limit of normal (ULN).Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) =< 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) =< 1.5 x ULN (unless B-ALL related)Xx_NEWLINE_xXProthrombin and partial thromboplastin times =< 1.2 x normal prior to biopsyXx_NEWLINE_xXPartial thromboplastin time (PTT) must be =< 1.5 x upper normal limit of institution's normal range and INR (international normalized ratio) < 1.5; subjects on anticoagulant (such as warfarin) will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigatorXx_NEWLINE_xXNormal prothrombin time (PT) or international normalized ratio (INR) and normal activated partial thromboplastin time (aPTT)Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULNXx_NEWLINE_xXContraindication to biopsy or prostatectomy (for neoadjuvant cohort only):\r\n* Bleeding disorders\r\n* Artificial heart valve\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT) >= 1.5 x ULN in patients not taking anticoagulation; patients on anticoagulation (e.g. enoxaparin, oral anticoagulants) are eligible regardless of PT/PTT; prior to biopsy, anticoagulation will be held per standard practiceXx_NEWLINE_xXImpaired coagulation as evidenced by:\r\n* International normalized ratio (INR) > 1.5 times ULN, or\r\n* Activated partial thromboplastin time (aPTT) > 1.5 times ULNXx_NEWLINE_xXAdequate hemostatic function as determined by prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.5 x ULN (unless on therapeutic coagulation, in which case the adequate level of anticoagulation will be determined by the investigator)Xx_NEWLINE_xXObtained within 14 days prior to registration; prothrombin time and partial thromboplastin time (PT / PTT) ? 50% increase from institutional ULNXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULNXx_NEWLINE_xXProthrombin time (PT)/activated partial thromboplastin time (aPTT) within normal limits at time of surgeryXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULNXx_NEWLINE_xXTotal bilirubin =< 1.5 X institutional limits; subjects with Gilbert's syndrome may have a bilirubin > 1.5 x upper limit of normal (ULN); activated partial thromboplastin time (aPTT), prothrombin time (PT) not to exceed 1.2 x ULNXx_NEWLINE_xXWithin 14 days prior to registration: International normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (aPTT) as follows:\r\n* In the absence of therapeutic intent to anticoagulate the patient: INR < 1.5 or PT < 1.5 x upper normal limit (ULN) or aPTT < 1.5 x ULN\r\n* In the presence of therapeutic intent to anticoagulate the patient: INR or PT and aPTT within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks before registrationXx_NEWLINE_xXUROTHELIAL CARCINOMA EXPANSION COHORT: Prothrombin (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) within 1.25 X ULN institutional limits, except where a lupus anti-coagulant has been confirmedXx_NEWLINE_xXProthrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXProthrombin time (PT) < 1.5Xx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x ULN after correction of nutritional deficiencies that may contribute to prolonged PT/PTTXx_NEWLINE_xXPartial thromboplastin time (PTT) < IULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) < 1.5 x upper limit of normal (ULN) and partial thromboplastin time (PTT) (activated PTT [aPTT]) < 1.5 x ULNXx_NEWLINE_xXInternational normalized ratio (INR) =< 1.5 or prothrombin time (PT) =< 1.5 ULN, and a partial thromboplastin time (PTT/activated partial thromboplastin time [aPTT]) =< 1.5 x ULNXx_NEWLINE_xXFor patients undergoing serial tumor biopsies, international normalized ratio (INR) and activated partial thromboplastin time (PTT) must be within 1.5 X the upper limit of normalXx_NEWLINE_xXInternational normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5 X ULN; patients on anticoagulation are expected to hold anticoagulation for at least 5 days prior to surgeryXx_NEWLINE_xXPartial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXInternational normalized ratio (INR) =< 1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institutionXx_NEWLINE_xXPerformed within 14 days (+3 working days) of treatment initiation: Coagulation international normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) =< 1.5 X ULNXx_NEWLINE_xXNormal coagulation parameters (elevated international normalized ratio (INR), prothrombin time or activated partial thromboplastin time (APTT) ?1.3 ULN range acceptable).Xx_NEWLINE_xXNo baseline prothrombin time (PT)/partial thromboplastin time (PTT) abnormalities, coagulopathies, or who are on any blood thinnersXx_NEWLINE_xXPartial thromboplastin time (PTT) < 1.5 x ULNXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) < 1.5 x ULNXx_NEWLINE_xXPartial thromboplastin time =< 1.5 x institutional ULN obtained within 14 days of first treatmentXx_NEWLINE_xXREGORAFENIB INCLUSION CRITERIA: International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULN (patients who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate, provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is predose as defined by the local standard of care)Xx_NEWLINE_xXSubjects must have adequate blood clotting function, defined as international normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT) =< 1.5 x ULNXx_NEWLINE_xXInternational Normalized Ratio (INR) > 1.5 ULN or activated partial thromboplastin time (aPTT) > 1.5 ULN. Subject is currently receiving or intending to receive anti-coagulants for therapeutic purposes. Prophylactic use of anticoagulants is allowed.Xx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXPartial thromboplastin time (PTT) (PTT/activated partial thromboplastin time [aPTT]) < 1.5 x ULN)Xx_NEWLINE_xXThe subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatmentXx_NEWLINE_xXPT and PTT <1.5 ULNXx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.5 x institutional ULNXx_NEWLINE_xXProthrombin time (PT) with an international normalized ratio (INR) =< 1.5 and a partial thromboplastin time (PTT) of =< 1.5 times the ULN; for patients on full-dose oral anti-coagulation (such as warfarin or rivaroxaban), in-range INR (usually between 2 and 3) and a PTT < 1.2 times the ULNXx_NEWLINE_xXNormal coagulation parameters (prothrombin time [PT], activated partial thromboplastin time [aPTT])Xx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.5 x ULN for the laboratoryXx_NEWLINE_xXProthrombin time (PT) (or international normalized ratio [INR]) and partial thromboplastin time (PTT) (or activated partial thromboplastin time [aPTT]) > 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT) < 14 sec; partial thromboplastin time (PTT) < 35 secXx_NEWLINE_xXInternational normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (for patients on anticoagulation they must be receiving a stable dose for at least 1 week prior to randomization)Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 X ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomizationXx_NEWLINE_xXProthrombin time (PT), partial thromboplastin time (PTT) =< 1.5 x ULNXx_NEWLINE_xXHas adequate blood clotting function, defined as: - International normalized ratio and activated partial thromboplastin time =<1.5 XULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatmentXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) < 50% of deviation from institutional upper limit of normal (IULN)Xx_NEWLINE_xXBlood coagulation parameters: prothrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a subject is on a stable dose of therapeutic warfarin or anticoagulants for management of venous thrombosis including pulmonary thrombo-embolus) and a partial thromboplastin time (PTT) =< 1.5 times the upper limit of normalXx_NEWLINE_xXFailure to meet the following laboratory levels on preoperative screening:\r\n* Platelet count >= 100,000 mm^3\r\n* Hemoglobin >= 10 g/dl\r\n* Prothrombin time (PT) =< 1.5 times upper limit of laboratory normal (ULN)\r\n* Activated partial thromboplastin time =< 1.5 times ULN\r\n* Serum creatinine < 2.5 times ULNXx_NEWLINE_xXProthrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.2 x IULNXx_NEWLINE_xXRequirement for anticoagulation treatment that increases international normalized ratio (INR) or activated partial thromboplastin time (aPTT) above the normal range (low dose deep vein thrombosis (DVT) or line prophylaxis is allowed).Xx_NEWLINE_xXNormal prothrombin time (PT) for ageXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULNXx_NEWLINE_xXThe subject has prothrombin time (PT)/ International Normalized Ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatmentXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR)/ activated partial thromboplastin time (aPTT) =< 1.5 x ULN (to be performed within 7 days prior to start of study treatment)Xx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.5 x ULN unless the patient is receiving anticoagulant therapyXx_NEWLINE_xXPartial thromboplastin time (PTT) < 1.3 x ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.2 x institutional ULNXx_NEWLINE_xXThe subject has prothrombin time (PT)/International Normalized Ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatmentXx_NEWLINE_xXPartial thromboplastin time (PTT) =< institution's upper limit of normal, unless receiving therapeutic low molecular weight heparinXx_NEWLINE_xXProthrombin time (PT) with normal limits (WNL); if patient is on warfarin for prophylactic clot presentation for indwelling catheter, PT/partial thromboplastin time (PTT) may be +/- 15 %Xx_NEWLINE_xXEvidence of bleeding diathesis or coagulopathy as documented by an elevated prothrombin time (PT), partial thromboplastin time (PTT) or bleeding timeXx_NEWLINE_xXPartial thromboplastin time (PTT) < 70 seconds (sec)Xx_NEWLINE_xXInternational normalized ratio =< 1.5 and activated prothrombin time =< 1.5 x ULN within 7 days prior to enrollment; the use of full-dose oral or parenteral anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits (according to the medical standard of the enrolling institution) and the patient has been on a stable dose of anticoagulants for at least two weeks prior to the first study treatmentXx_NEWLINE_xXNormal blood coagulation as evidenced by partial thromboplastin time (PTT) < 1.5 IULN and international normalized ratio (INR) < 1.5Xx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.2 x ULNXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) within normal limits (secpatient may be eligible for trial if abnormality is deemed clinically insignificant and cleared for protocol therapy by Hematology Consult service)Xx_NEWLINE_xXProthrombin time (PT) such that international normalized ratio (INR) is < 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin or low molecular weight heparin) and a partial thromboplastin time (PTT) < 1.2 times controlXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.2 x ULNXx_NEWLINE_xXAbnormal prothrombin time (PT) (international normalized ratio [Inr]) > 1.5 INR or partial thromboplastin time (PTT) > 42 seconds (sec) (may be corrected with flash frozen plasma [FFP], cryoprecipitate, vitamin K, etc)Xx_NEWLINE_xXThe subject has adequate coagulation function as defined by international normalized ratio (INR) =< 1.5 and a partial thromboplastin time (PTT) (PTT/aPTT) < 1.5 x ULN\r\n* Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapyXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) < 1.5 x institutional ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x institutional ULNXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) =< 1.4 times upper limit of normal rangeXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR); partial thromboplastin time (PTT) =< 1.3; =< 1.3 x ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN for ageXx_NEWLINE_xXAbnormal coagulation parameter (prothrombin time [PT] or activated partial thromboplastin time [aPTT] > 1.3x longer than standard reference)Xx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) =< 2 x normal outside the setting of stable chronic anticoagulation therapyXx_NEWLINE_xXActivated partial thromboplastin time/ partial thromboplastin time (aPTT/PTT) ?1.5 x ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ? 1.5 x ULN (except for subjects receiving anticoagulation therapy)Xx_NEWLINE_xXPatients must have adequate coagulation (international normalized ratio [INR] ? 1.5, activated partial thromboplastin time [aPTT] ?1.5 X the upper limit of normal [ULN])Xx_NEWLINE_xXNormal prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT)Xx_NEWLINE_xXPT and PTT ? 1.5 X ULNXx_NEWLINE_xXProthrombin time less than 1.5 × ULN for the institutionXx_NEWLINE_xXLaboratory values: Screening serum creatinine > upper limits of normal (ULN); total bilirubin > ULN: alanine aminotransferase (ALT) and AST >/= 2.5 ULN or >/= 5.0 x ULN if liver metastases are present; absolute neutrophil count < 1,500/mm3, platelet concentration < 100,00/mm3, hematocrit level < 27% for females or < 30% for males, or coagulation tests (prothrombin time [PT], partial thromboplastin time [PTT], International Normalized Ratio [INR]) > 1.5 x ULN unless on therapeutic doses of warfarin.Xx_NEWLINE_xXOr partial thromboplastin time [PTT] > 100 secXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) unless receiving clinically indicated anticoagulant therapyXx_NEWLINE_xXORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4 x ULNXx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Prothrombin time (PT) and partial thromboplastin time (PTT) < 1.4 x ULNXx_NEWLINE_xXProthrombin time (PT) and/or partial thromboplastin time (PTT) =< 1.5 X ULN.Xx_NEWLINE_xXProthrombin time/partial thromboplastin time (PT/PTT) ? 1.5 x upper limit of normal (ULN) (unless receiving anticoagulation)Xx_NEWLINE_xXProthrombin time (PT) =< 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) ? 1.5 x of institutional upper limit of normal (ULN) (Note: If coagulopathy is related to disease, this criteria do not apply) within 14 days prior to registrationXx_NEWLINE_xXInternational normalized ratio (INR) or prothrombin time (PT) =< 1.5 x ULN unless on anticoagulation therapy, in which case PT or partial thromboplastin time (PTT) should be in the therapeutic rangeXx_NEWLINE_xXWithin 14 days prior to first dose of study drug treatment: International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULNXx_NEWLINE_xXThe subject has prothrombin time (PT)/institutional normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN within 7 days before the first dose of study treatmentXx_NEWLINE_xXAll screening labs should be performed within 14 days (+3 working days) of treatment initiation: international normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) =< 1.5 x ULN.Xx_NEWLINE_xXINR (prothrombin time ratio) or partial thromboplastin time (PTT) > 1.5 x ULN (Please note: patients with hematopoietic cell transplantation (Hct) < 30%, WBC < 2500/mm/^3 and platelets < 50,000/mm^3 immediately prior to leukapheresis. The procedure may be deferred.)Xx_NEWLINE_xXPartial thromboplastin time (PTT) must be =< 1.5 X upper normal limit of institution's normal range and INR (international normalized ratio) =< 1.5; subjects on anticoagulant (such as coumadin) will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigator; alternate anticoagulation should be consideredXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) less than or equal to 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) less than or equal to 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) performed within 3 weeks prior to starting study therapy must be =< 1.5 x ULNXx_NEWLINE_xXInternational normalized ratio (INR) within 1.5 times ULN (or if receiving anticoagulant therapy an INR of =< 3.0 is allowed with concomitant increase in prothrombin time (PT) or an activated partial thromboplastin time (aPTT) =< 2.5 x control)Xx_NEWLINE_xXSerum prothrombin time, international normalized ratio (INR) and partial thromboplastin times which fall within normal limits or levels outside the normal range determined not to be clinically significant by the PIXx_NEWLINE_xXProthrombin time (PT) or international normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.2 times upper limit of normalXx_NEWLINE_xXThe use of full?dose oral or parenteral anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits (according to the medical standard of the enrolling institution), and the patient has been on a stable dose of anticoagulants for at least two weeks prior to the first study treatmentXx_NEWLINE_xXInternational normalized ratio (INR)/ partial thromboplastin time (PTT) < 1.5 x ULN; (subjects who are treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring [day 5 of cycle 1 and day 1 of each cycle] is mandatory) will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care)Xx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) < 1.5 x normal institutional standardXx_NEWLINE_xXProthrombin Time (PT) and activated partial thromboplastin time (PTT) ? 1.6x unless therapeutically warrantedXx_NEWLINE_xXActivated partial thromboplastin time (APTT)/PTT =< 1.5 x institutional ULNXx_NEWLINE_xXPartial thromboplastin time (PTT) within normal limits (+/- 15%)Xx_NEWLINE_xXThe subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the laboratory ULN =< 7 days before the first dose of study treatmentXx_NEWLINE_xXProthrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN), OR international normalized ratio (INR) < 1.5Xx_NEWLINE_xXActivated partial thromboplastin time (APTT)/partial thromboplastin time (PTT) =< 1.5 x ULNXx_NEWLINE_xXInternational normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULNXx_NEWLINE_xXInternational normalized ratio (INR) or partial thromboplastin time (PTT)/prothrombin time (PT) =< 1.5 ULN, unless the patient is on stable therapeutic dose of warfarinXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.5 x ULN for the laboratoryXx_NEWLINE_xXInternational normalized ratio INR/ prothrombin time (PT)/ partial thromboplastin time (PTT) each < 1.5 x ULNXx_NEWLINE_xXARM A: obtained =< 14 days prior to registration: \r\n* Activated partial thromboplastin time (aPTT) =< 1.5 x ULNXx_NEWLINE_xXPartial thromboplastin time (PTT) =< 48 seconds (1.25 x ULN)Xx_NEWLINE_xXActivated partial thromboplastin time (aPTT), prothrombin time (PT) =< 1.2 x upper limit of normal (ULN)Xx_NEWLINE_xXObtained within 30 days prior to registration: Activated partial thromboplastin time (aPTT) =< 2 x ULN (Note: use of vitamin K antagonist is not allowed)Xx_NEWLINE_xXProthrombin time (PT) and activated partial thromboplastin time (aPTT) =< upper limit of normal (ULN) for ageXx_NEWLINE_xXProthrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULNXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) within normal limits (11.6 - 15.2 / 25.3 - 37.3 sec)Xx_NEWLINE_xXProthrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.5 x ULN (or an in range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) less than or equal to 1.5 times the upper limit of normalXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomizationXx_NEWLINE_xXProthrombin time (PT) > 12 seconds or partial thromboplastin time (PTT) > 31 secondsXx_NEWLINE_xXThe subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 x the laboratory ULNXx_NEWLINE_xXProthrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.3 x ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) must be < 1.5 x the upper limit of the normal range (ULN); except if, in the opinion of the investigator, the aPTT is elevated because of a positive lupus anticoagulantXx_NEWLINE_xXActivated partial thromboplastin time (APTT) or partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXInternational normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN; (patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care)Xx_NEWLINE_xXPartial thromboplastin time (PTT) must be =< 1.5 × upper normal limit of institution's normal rangeXx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) =< 2 x ULNXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXActive bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, international normalized ratio (INR) or platelet count (as determined by institutional lab parameters) at the time of screeningXx_NEWLINE_xXProthrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.2 x upper limit of normal (ULN)Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) unless using warfarin for therapeutic anti-coagulationXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with PT/INR/PTT established within the therapeutic range prior to randomization; subjects will be eligible if it is determined by a hematologist that the cause is not associated with clinical bleeding (e.g., deficiency of factor XII), within 2 weeks of the first dose of study treatmentXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomizationXx_NEWLINE_xXInternational normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULNXx_NEWLINE_xXFor patients on Coumadin, INR/prothrombin time (PT)/PTT must be > 1.5 ULNXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.2 x ULNXx_NEWLINE_xXProthrombin time (PT) =< 1.2 x ULNXx_NEWLINE_xXInternational normalized ratio (INR) =< 1.5 and activated partial thromboplastin time (aPTT) within 1.1 x ULN; patients on warfarin therapy are not eligible due to the requirement for multiple biopsiesXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) within 1.5 times the institutional upper limit of normalXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional upper limit of normal (IULN) (subjects on Coumadin are included if their coagulation is within a normal therapeutic range)Xx_NEWLINE_xXPartial thromboplastin time (PTT) < 1.5 x the upper limit of institution’s normal rangeXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 x the upper limit of normal within 10 days prior to registration unless the patient is receiving coumadin and has a stable INR that is in range for the desired level of anticoagulationXx_NEWLINE_xXProthrombin time (PT) such that international normalized ratio (INR) is =< 1.5 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) < 1.5 x ULNXx_NEWLINE_xXInternational normalized ratio ?1.5 × ULN and partial thromboplastin time ?5 seconds above ULN.Xx_NEWLINE_xXProthrombin time (PT) such that international normalized ratio (INR) is less than or equal to 1.2 x ULN (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) less than or equal to 1.2 x ULN; Note: Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulationXx_NEWLINE_xXOther: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULNXx_NEWLINE_xXNormal coagulation [prothrombin time and partial thromboplastin time within normal limits (±15%)].Xx_NEWLINE_xXOnly for patients who test positive for hepatitis B virus or hepatitis C virus: partial thromboplastin time (PTT)/international normalized ratio (INR) =< ULN (institutional)Xx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.2 x IULN (if not receiving anticoagulation therapy)Xx_NEWLINE_xXProthrombin time (PT) or partial thromboplastin time (PTT) test >= 1.3 x laboratory upper limit of normal (ULN) within 7 days before the first dose of study treatmentXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) ? 1.5 X ULN after correction of nutritional deficiencies that may have contributed to prolonged PT/PTT.Xx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 upper limit of normal (ULN)Xx_NEWLINE_xXProthrombin time (PT) and activated partial thromboplastin time (APTT) =< 1.5 times upper limit of normalXx_NEWLINE_xXINR ? 2.3 or Prothrombin time (PT) ? 6 seconds above control;Xx_NEWLINE_xXInternational normalized ratio (INR), activated partial thromboplastin (aPTT), or partial thromboplastin time (PTT) < 1.5 × ULN (unless on anticoagulant treatment at screening)Xx_NEWLINE_xXOther: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN.Xx_NEWLINE_xXProthrombin time (PT), partial thromboplastin time (PTT) and international normalized ratio (INR) =< 1.5 upper limit of normal (ULN)Xx_NEWLINE_xXBaseline laboratory data as defined as: Hemoglobin (Hb): >=8g/dL Absolute Neutrophil Count (ANC): >=1000/µL Platelet (PLT): >=25000/µL Glomerular Filtration Rate (GFR) or Creatinine Clearance: >=30ml/min Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): <3 x Upper Limit of Normal (ULN) Bilirubin - total: <1.5 x ULN Activated Partial Thromboplastin Time (aPTT), Prothrombin Time (PT) or International Normalized Ratio (INR): <=1.5 x ULN PT <=1.5 x ULN, INR <=1.5Xx_NEWLINE_xXAMKL PATIENTS: Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x ULNXx_NEWLINE_xXOther: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULNXx_NEWLINE_xXCoagulation parameters: international normalized ratio (INR) =< 2, prothrombin time (PT) and partial thromboplastin time (PTT) < 1.5 X institutional ULNXx_NEWLINE_xXCoagulation: Prothrombin time (PT) <1.5 × ULN and partial thromboplastin time (PTT) <1.5 × ULNXx_NEWLINE_xXNormal prothrombin time (PT)/international normalized ratio (INR) and partial prothrombin time (PTT)Xx_NEWLINE_xXPartial Thromboplastin Time (PTT) ?1.5x upper limit of normal (ULN) unless receiving therapeutic anticoagulation.Xx_NEWLINE_xXEvidence of bleeding diathesis, coagulopathy as documented by an elevated (? 1.5 x ULN) prothrombin time (PT), partial thromboplastin time (PTT), or bleeding time. The use of full-dose oral or parenteral anticoagulants is permitted as long as the PT or aPTT is within therapeutic limits (according to the medical standard of the enrolling institution) and the subject has been on a stable dose of anticoagulants for at least 2 weeks prior to the first study treatment.Xx_NEWLINE_xXINR and PTT within 1.5 X institutional ULNXx_NEWLINE_xXAcceptable coagulation studies as demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits (+/-15%).Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) =< 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULNXx_NEWLINE_xXFor patients not receiving therapeutic anticoagulation: international normalized ratio (INR) or activated partial thromboplastin time (aPTT) =< 1.5 x ULN, obtained within 14 days prior to initiation of study treatmentXx_NEWLINE_xXIndividuals not receiving anticoagulant medication must have an international normalized ratio (INR) ? 1.5 and activated partial thromboplastin (aPTT) ? 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXProthrombin time (PT) or prolongation of the activated thromboplastin time (aPTT) >1.5 ULN or active uncontrolled coagulopathy or bleeding disorder.Xx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) < 1.4x the ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x ULNXx_NEWLINE_xXPT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULNXx_NEWLINE_xXInternational normalized ratio (INR)/ Partial thromboplastin time (PTT) ? 1.5 x ULN. (Subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care.Xx_NEWLINE_xXInternational normalized ratio (INR) and activated partial thromboplastin time (aPTT) > 1.5 x ULN, in subject who is not therapeutically anticoagulated.Xx_NEWLINE_xXActivated Partial Thromboplastin Time (aPTT) ?1.5 X ULNXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional upper limit of normal (ULN)Xx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.5 times the upper limit of normalXx_NEWLINE_xXProthrombin time (PT) such that international normalized ratio (INR) is =< 1.5 and a partial thromboplastin time (PTT) =< 1.2 time the upper limit of normal unless the patient is therapeutically anti-coagulated for history of cancer-related thrombosis and has stable coagulation parametersXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN for the labXx_NEWLINE_xXPartial thromboplastin time > 50 seconds (secs)Xx_NEWLINE_xXProthrombin time (PT) within normal limits (UIHC)Xx_NEWLINE_xXThe subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 × the laboratory ULN within 7 days before the first dose of study treatmentXx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.2 x institutional ULNXx_NEWLINE_xXProthrombin time (PT) < 1.2 x ULNXx_NEWLINE_xXPatients must NOT have a prolonged prothrombin time (PT) or partial thromboplastin time (PTT) (greater than 1.2 times the institutional upper limit of normal)Xx_NEWLINE_xXInternational normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless on medication known to alter INR and/or aPTTXx_NEWLINE_xXProthrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN), OR international normalized ratio (INR) < 1.5Xx_NEWLINE_xXWithin 14 days of enrollment: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN if not on therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable doseXx_NEWLINE_xXInternational normalized ratio (INR) ? 1.5 and activated partial thromboplastin time (aPTT) ? 1.5 x the ULN.Xx_NEWLINE_xXProthrombin time (PT)/ international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXWithin 14 days prior to registration: coagulation parameters (international normalized ratio [INR], activated partial thromboplastin time [aPTT]) =< 1.25 x institutional ULNXx_NEWLINE_xXThe following laboratory values obtained =< 14 days prior to randomization\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 X ULN if not anticoagulated; within local institutional guidelines per local physician if anticoagulatedXx_NEWLINE_xXProthrombin time/international normalized ratio (INR) and partial thromboplastin time within normal limitsXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) < 1.5 x institutional upper limit of normal, within 14 days of study registrationXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.2 x ULN unless on anticoagulation medication with stable dosing for at least one month; in addition, patient must be able to stop taking medication for up to a week in order to have percutaneous biopsies of tumor tissue performedXx_NEWLINE_xXNo patients will have coagulation parameters: international normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% deviation of the institutional ULNXx_NEWLINE_xXProthrombin time (PT) or international normalized ratio (INR), and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal unless patient is receiving anticoagulants; if patient is on warfarin therapy, levels should be within therapeutic rangeXx_NEWLINE_xXOther: Prothrombin time (PT) and partial thromboplastin time (PTT) < ULN.Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) < 1.5 x ULNXx_NEWLINE_xXInternational normalized ratio (INR), prothrombin time (PT), or activated partial thromboplastin time (APTT) as follows: in the absence of therapeutic intent to anticoagulate the patient: INR < 1.5 or PT < 1.5 x ULN or aPTT < 1.5 x ULN; in the presence of therapeutic intent to anticoagulate the patient: INR or PT and aPTT within therapeutic limits (according to the medical standard in the institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks before registration (within 7 days prior to registration)Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 X upper limit of normal (ULN)Xx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) =< 2 x ULNXx_NEWLINE_xXPartial thromboplastin time 5 seconds above ULN.Xx_NEWLINE_xXInternational normalized ratio (INR) > 1.6 and a partial thromboplastin time (PTT) > 40 secondsXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXPartial thromboplastin time (PTT) < 1.5 x ULN for institution unless patient is on planned therapy with heparin or heparin-like products obtained =< 14 days prior to registrationXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULNXx_NEWLINE_xXInternational normalized ratio (INR)/partial thromboplastin time (PTT) 1.5 x ULN; (subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care)Xx_NEWLINE_xXInternational normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN (obtained =< 7 days prior to randomization)\r\n* NOTE: patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of careXx_NEWLINE_xXCoagulation parameters (international normalized ratio [INR], activated partial thromboplastin time [aPTT]) =< 1.25 x ULN institutional limits, except where a lupus anti-coagulant has been confirmedXx_NEWLINE_xXPartial thromboplastin time (PTT) less than or equal to 1.3 x ULNXx_NEWLINE_xXNormal prothrombin time (PT)/partial thromboplastin time (PTT)Xx_NEWLINE_xXInternational normalized ratio (INR) or prothrombin time (PT) activated partial thromboplastin time (aPTT) =< 1.5 X ULN; if on active anticoagulants prior to study treatment, levels must be within standard therapeutic ranges per investigatorXx_NEWLINE_xXPartial thromboplastin time (PTT) =< 60, international normalized ratio (INR) =< 1.5 x institutional ULN unless on warfarin therapy (investigator would need to determine if safe for participant to stop warfarin prior to biopsy and warfarin therapy)Xx_NEWLINE_xXInternational normalized ratio (INR) < 2, prothrombin time (PT) < 20 sec, and partial thromboplastin time (PTT) < 55 secXx_NEWLINE_xXInternational normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN; Note-subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that their medication dose and INR/PTT are stable; close monitoring (day 1 of each cycle) is mandatory; if either of these values is above the therapeutic range, the doses should be modified and the assessments should be repeated weekly until they are stableXx_NEWLINE_xXPartial thromboplastin time (PTT) < 1.5 times upper limit of normal within 14 days before enrollmentXx_NEWLINE_xXAdequate coagulation parameters, defined as International Normalisation Ratio <1.5 x ULN or activated partial thromboplastin time <1.5 x ULN.Xx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.5 times the upper limit of normalXx_NEWLINE_xXAdequate coagulation system defined as an international normalized ratio (INR) of less than 1.4 and a partial thromboplastin time (PTT) of less than 34Xx_NEWLINE_xXInternational normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN; subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of careXx_NEWLINE_xXInternational normalized ratio (INR) < 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate; for patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stableXx_NEWLINE_xXprothrombin time (PT) and activated partial thromboplastin time (PTT) ? 1.6 x control unless therapeutically warrantedXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) < 1.5 ULN and partial thromboplastin time (PTT) activated partial thromboplastin time (aPTT) < 1.5 X ULN; if value is higher due to hepatic involvement by CLL, patient is eligibleXx_NEWLINE_xXAt least 4 weeks (28 days) prior to registration: Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN (unless on medication known to alter INR and aPTT)Xx_NEWLINE_xXThe subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 x the institutional ULN =< 7 days before the first dose of study treatment, unless PT/PTT prolongation known to be secondary to conditions not associated with increased bleeding risk (as on antiphospholipid antibody syndrome)Xx_NEWLINE_xXPartial thromboplastin time (PTT) =< 60, international normalized ratio (INR) =< 1.5 institutional ULN unless on warfarin therapy (investigator would need to determine if safe for participant to stop warfarin prior to [optional] biopsy)Xx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) must not be more than 1.5 x upper limit of normal (ULN) within 72 hours prior to enrollment; PT and PTT should be drawn by venipuncture, rather than from a central venous catheter when feasibleXx_NEWLINE_xXInternational normalized ratio (INR), activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) > 1.5 × ULN (unless on anticoagulation medication)Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal (ULN)Xx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.2 x ULN (tested within 14 days prior to registration)Xx_NEWLINE_xXPartial thromboplastin time (PTT) =< 60Xx_NEWLINE_xXProthrombin time (PT) or international normalized ratio (INR), and activated partial thromboplastin time (aPTT) =< 1.2 x ULN; subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulationXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.3 x institutional ULN; subjects receiving anticoagulation treatment may be allowed to participate with INR established within the therapeutic range prior to randomization\r\n* NOTE: this applies to patient in the normal and renal dysfunction cohorts (N, R3 and R4); elevated PT/INR is allowed for patients in the liver dysfunction cohortsXx_NEWLINE_xXCoagulopathy (as evidence by prothrombin time [PT] or activated partial thromboplastin time [APTT] > 1.5 times upper limit of normal in patients not undergoing anticoagulation)Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT)/activated partial thromboplastin time (aPTT) < 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) < 2 x normal outside the setting of stable chronic anticoagulation therapyXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.2 x ULNXx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.5 X institutional upper limit of normalXx_NEWLINE_xXPartial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXPartial thromboplastin time (PTT) >= 45 secondsXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 x institutional upper limits of normalXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time =< 1.5 upper limit of normal (ULN) unless using warfarin for therapeutic anti-coagulationXx_NEWLINE_xXAbsence of active treatment with systemic anticoagulation and a baseline prothrombin time (PT) and activated partial thromboplastin time (aPTT) that does not exceed 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) (Note: subjects receiving anticoagulation treatment may enroll with INR established within the therapeutic range prior to day 1 [D1] of treatment)Xx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.2 x IULNXx_NEWLINE_xXThe subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 × the laboratory ULN within 7 days before the first dose of study treatmentXx_NEWLINE_xXPartial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) =< upper limit of normal (ULN) per institutional laboratory rangeXx_NEWLINE_xXProthrombin time (PT)/activated partial thromboplastin time (aPTT) =< 1.2 x institution’s ULNXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) > 1.5 x ULN (patients on heparin treatment must have an aPTT between 1.5 - 2.5 x ULN), orXx_NEWLINE_xXInternational normalized ratio (INR) =< 1.5 and activated partial thromboplastin time (aPTT) within normal limits (WNL)Xx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.5 x institutional upper limits of normalXx_NEWLINE_xXSubjects must have normal coagulation parameters as measured by prothrombin time (PT)/partial thromboplastin time (PTT)Xx_NEWLINE_xXProthrombin time (PT) or international normalized ratio (INR), and activated partial thromboplastin time (APTT) =< 1.5 x upper limit of normal (ULN), unless the abnormality can be explained by the presence of lupus anticoagulant or if these values are in the therapeutic range for a patient on low molecular weight heparinXx_NEWLINE_xXProthrombin time (PT)/INR and partial thromboplastin time (PTT) =< grade 1 within two weeks before initial biopsy of visceral organsXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.2 X ULN; subjects receiving anticoagulant therapy are eligible if their aPTT is stable and within the recommended range for the desired level of anticoagulationXx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.2 ULN; subjects receiving anticoagulant therapy are eligible if their PTT is stable and within the recommended range for the desired level of anticoagulationXx_NEWLINE_xXThe participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 X the laboratory ULNXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.2 X ULNXx_NEWLINE_xXActivated prothrombin time (APTT) =< 1.5 x ULNXx_NEWLINE_xXPartial thromboplastin time (PTT) must be =< 1.5 × upper normal limit of institution's normal rangeXx_NEWLINE_xXThe patient has a PT (or INR) and PTT up to 1.25×ULNXx_NEWLINE_xXProthrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin for management of venous thrombosis) and a partial thromboplastin time (PTT) < 1.2 x ULNXx_NEWLINE_xXPartial thromboplastin time (PTT) < 1.2 times institutional upper limit of normalXx_NEWLINE_xXProthrombin and partial thromboplastin times =< 1.2 x normal prior to biopsyXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.2 X ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 X the ULN unless a subject is receiving Coumadin and has stable INR which is in range for the desired level of anticoagulationXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.2 X ULNXx_NEWLINE_xXFor patients undergoing biopsy procedures: Prothrombin time (PT) and activated partial thromboplastin time (aPTT) must be within the normal rangeXx_NEWLINE_xXProthrombin time (PT) =< 2 x normal outside the setting of stable chronic anticoagulation therapyXx_NEWLINE_xXPartial thromboplastin time (PTT) =< 2 x normal outside the setting of stable chronic anticoagulation therapyXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) =< 1.2 X upper limit normal (ULN)Xx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 1.2 x ULNXx_NEWLINE_xXInternational normalized ratio (INR)/partial thromboplastin time (PTT) within 1.5 x upper limit of normal (Common Terminology Criteria for Adverse Events [CTCAE] 4.0 grade 1 abnormality is acceptable)Xx_NEWLINE_xXAbnormal laboratory values as defined by protocol for creatinine, creatinine clearance, aspartate transaminase (AST) or alanine transaminase (ALT), total bilirubin, international normalized ration (INR), partial thromboplastin time (PTT) or activated partial thromboplastin time (aPPT), unless these abnormalities are due to underlying lymphomaXx_NEWLINE_xXInternational normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN\r\n* Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of careXx_NEWLINE_xXInternational normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULN; (anticoagulation is allowed if target INR =< 1.5 on a stable dose of warfarin or on a stable dose of low molecular weight [LMW] heparin for > 2 weeks at time of randomization)Xx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.5 X institutional ULN unless patients are on therapeutic anticoagulation with warfarinXx_NEWLINE_xXEXPANSION COHORT ONLY: Partial thromboplastin time (PTT) =< 1.5 X institutional ULN unless patients are on therapeutic anticoagulation with warfarinXx_NEWLINE_xXInternational normalized ratio (INR) > 1.5 and activated partial thromboplastin time (aPTT) > 1.5 x the ULN (except for subjects receiving anticoagulation therapy) in the absence of therapeutic intent to anticoagulate the subject; therapeutic anticoagulation is permittedXx_NEWLINE_xXThe patient has an adequate coagulation function as defined by international normalized ratio (INR) =< 1.5 x upper limit of normal (ULN) or prothrombin time (PT) =< 1.5 x ULN, and partial thromboplastin time (PTT or aPTT) =< 1.5 x ULN (those receiving anticoagulation therapy except low molecular weight heparin are excluded) within 30 days prior to registrationXx_NEWLINE_xXInternational normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 X ULN unless on medication known to alter INR and aPTTXx_NEWLINE_xXInternational normalize ratio (INR) and the partial thromboplastin time (PTT) < 1.5 x ULN. (Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of an underlying abnormality in coagulation parameters exists)Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) > 1.5 x ULN and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) > 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder)Xx_NEWLINE_xXCoagulation parameters (international normalized ratio [INR], activated partial thromboplastin time [aPTT]) within 1.25 x upper limit of normal institutional limits, except where a Lupus anti-coagulant has been confirmedXx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.2 times the ULN unless the patient is receiving therapeutic anticoagulationXx_NEWLINE_xXProthrombin time or INR =< 1.5 x ULN unless receiving therapeutic anticoagulationXx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.2 x upper limit of normal (ULN) unless the patient is receiving therapeutic anticoagulationXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) < 2 x normal outside the setting of stable chronic anticoagulation therapyXx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) =< 120% of control, unless patient has the presence of a lupus anticoagulantXx_NEWLINE_xXactive, uncorrected bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, or INR at the time of HIFU (use international lab normal ranges for parameters);Xx_NEWLINE_xXInternational normalized ratio (INR) =< 1.5 and partial thromboplastin time (PTT) within normal limits; (patients who are on therapeutic anticoagulation with warfarin should have documentation of INR =< 1.5 or PTT within normal limits prior to initiating that therapy)Xx_NEWLINE_xXThe patient has a prothrombin time (PT) (international normalized ratio [INR]) =< 1.5 and a partial thromboplastin time (PTT) =< 3 seconds above the upper limits of normal if the patient is not on anticoagulation; if a patient is on full-dose anticoagulants, the following criteria should be met for enrollment: \r\n* The patient must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on stable dose of low molecular weight (LMW) heparin\r\n* The patient must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices)Xx_NEWLINE_xXInternational normalized ratio (INR), activated partial thromboplastin time (aPTT), or partial thromboplastin time (PTT) < 1.5 × ULN (unless on anticoagulant treatment at screening)Xx_NEWLINE_xXProthrombin time (PT), partial thromboplastin time (PTT) less than or equal to 1 to 1.5 x upper limit of normal, CTCAE v 4.0 grade 1 except for patients on therapeutic anticoagulationXx_NEWLINE_xXPatients must have baseline prothrombin time (PT)/international normalized ratio (INR) < 3 x institutional upper limit of normal and partial thromboplastin time (PTT) < 3 x ULN within 7 days of initiating the induction cycle; (for patients with coagulation abnormalities that are correctable, coagulation factor support per institutional standard of care for AML is allowed)Xx_NEWLINE_xXProthrombin time (PT) and activated partial thromboplastin time (aPTT) <1.5 times the upper limit of normal (ULN)Xx_NEWLINE_xXProthrombin time and activated partial thromboplastin time (aPTT) < 1.5 times the upper limit of normal (ULN)Xx_NEWLINE_xXSubjects must have adequate coagulation as assessed by: international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN (CTCAE Grade <=1), partial thromboplastin time (PTT) <=1.5 x ULN (CTCAE Grade <=1)Xx_NEWLINE_xXCoagulopathy (as evidenced by prothrombin time [PT] or activated partial thromboplastin time [APTT] > 1.5 times in control patients not undergoing anticoagulation)Xx_NEWLINE_xXInternational normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULNXx_NEWLINE_xXProthrombin time (PT-INR)/ partial thromboplastin time (PTT) ? 1.5 x ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement that is pre dose as defined by the local standard of careXx_NEWLINE_xXPT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN (When treated with warfarin or other vitamin K antagonists, then INR ?3.0).Xx_NEWLINE_xXInternational normalized ratio (INR)/ partial thromboplastin time (PTT) =< 1.5 x ULNXx_NEWLINE_xXSubject has acceptable coagulation studies (obtained ? 14 days prior to starting Cycle 1 Day 1) partial thromboplastin time (PTT) < 1.2 x ULN and INR ? 1.5 x ULN.Xx_NEWLINE_xXInternational normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN (subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care)Xx_NEWLINE_xXNormal partial thromboplastin time (PTT) and either international normalized ratio (INR) or prothrombin time (PT) < 1.5 x ULNXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) ? 1.5 x the upper limit of the normal range (ULN) per institutional laboratory normal rangeXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) ? 1.5 x the upper limit of the normal range (ULN) per institutional laboratory normal rangeXx_NEWLINE_xXInternational normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN; subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is defined by the local standard of careXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 upper limit of normal (ULN)Xx_NEWLINE_xXThe participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.3 the laboratory ULN within 7 days before the first dose of study treatmentXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) =< 1.5 X ULNXx_NEWLINE_xXPartial thromboplastin time (PTT) < 1.2 x institutional upper limits of normalXx_NEWLINE_xXInternational normalized ratio of prothrombin time and activated partial thromboplastic time </=1.5 times the ULN. Subjects who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate if no underlying abnormality in coagulation parameters exists per medical history.Xx_NEWLINE_xXActivated partial thromboplastin time (APTT) =< 1.5 x upper limit of normal unless patient is receiving anticoagulants; if patient is on anticoagulation therapy, levels should be within therapeutic rangeXx_NEWLINE_xXProthrombin time < 1.5 x ULNXx_NEWLINE_xXProthrombin time (PT) or International Normalized Ratio (INR) ? 1.25 x ULN; for patients with hepatocellular carcinoma only, INR <1.7 or prothrombin time (PT) or < 4 seconds above ULN (i.e. Child-Pugh Score is no greater than 1 for the coagulation parameter); for patients with hepatocellular carcinoma only, serum albumin > 2.8 g/dL (i.e. Child-Pugh Score for albumin is no greater than 2). For the hematologic malignancy patients, the coagulation and albumin status cited above do not applyXx_NEWLINE_xXThe subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 x the laboratory ULNXx_NEWLINE_xXNormal prothrombin timeXx_NEWLINE_xXPatients must have an International Normalized Ratio (INR) < 1.5 and a partial thromboplastin time (PTT) no greater than upper limits of normal within 1 week prior to randomizationXx_NEWLINE_xXInternational normalized ratio (INR) < 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participateXx_NEWLINE_xXProthrombin time (PT) ? 1.5 x ULNXx_NEWLINE_xXActivated partial thromboplastin time (PTT) < 1.5 x ULNXx_NEWLINE_xXTPI 287 may interfere with Coumadin dosing and patients who are taking this combination will require monitoring of their prothrombin time (PT), partial thromboplastin time (PTT), and international normalized ratio (INR)Xx_NEWLINE_xXInternational normalized ratio (INR) and activated partial thromboplastin time (aPTT) =< 1.5 x ULN\r\n* Unless the patient is on therapeutic anticoagulationXx_NEWLINE_xXProthrombin time (PT) such that international normalized ratio (INR) is =< 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) =< 1.5 times the institutional upper limit of normal; patients receiving low molecular weight heparin for the prevention or treatment of venous thromboembolic disease are eligible if considered clinically stable on their regimenXx_NEWLINE_xXActivated partial thromboplastin time (APTT)/partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 upper limit of normal (ULN)Xx_NEWLINE_xXProthrombin time (PT) or international normalized ratio (INR), and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal unless subject is receiving anticoagulants; if the subject is on anticoagulation therapy, levels should be within therapeutic rangeXx_NEWLINE_xXThe subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test >= 1.5 x the laboratory ULN within 7 days before the first dose of study treatmentXx_NEWLINE_xXThe subject has prothrombin time/international normalized ratio (PT/INR) or partial thromboplastin time (PTT) test results at screening >= 1.5 x the laboratory upper limit of normalXx_NEWLINE_xXSerum creatinine >ULN, or Prothrombin time (PT) or international normalized ratio (INR) >1.5 × ULN or activated partial thromboplastin time (aPTT) > 1.5 × ULNXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) ? 1.25 ULN and international normalized ratio (INR) ? 1.3 (unless the subject is receiving therapeutic anticoagulants);Xx_NEWLINE_xXProthrombin time (PT)-international normalized ratio (INR)/partial thromboplastin time (PTT) < 1.5 x ULN except in patients receiving active anticoagulationXx_NEWLINE_xXPartial thromboplastin time (PTT) must be =< 1.5 X upper normal limit of institution's normal range and international normalized ratio (INR) < 1.5; subjects on anticoagulant (such as Coumadin) will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigatorXx_NEWLINE_xXCoagulation status: prothrombin time (PT) ? 1.5 ULN or INR within normal limits; and partial thromboplastin time (PTT) ? 1.2 × ULNXx_NEWLINE_xXNormal PT or INR and aPTTXx_NEWLINE_xXPT/INR <1.5 x ULN and PTT/ aPTT <1.5 x ULNXx_NEWLINE_xXActivated partial thromboplastin time (APTT) must not exceed 32.5 seconds (normal range 21.8-31.5 seconds); international normalized ratio (INR) must not exceed 1.30 (normal range 0.87-1.18)Xx_NEWLINE_xXInternational Normalized Ratio (INR) and activated partial thromboplastin time [PTT] ? 1.5×ULN, if not therapeutically anticoagulated.Xx_NEWLINE_xXCoagulation parameters: International normalised ratio (INR) < 2 and partial prothrombin Time (PTT) = 2xULNXx_NEWLINE_xXPatients with known bleeding diathesis, or PT (Prothrombin time) or aPTT (activated partial thromboplastin time) > 1.5x ULN or <0.5x LLN.Xx_NEWLINE_xXProthrombin time (PT) and activated partial thromboplastin time (aPTT) <=1.5*ULNXx_NEWLINE_xXPatients must have prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 x the upper limit of normalXx_NEWLINE_xXHas adequate blood clotting function, defined as: International normalized ratio and activated partial thromboplastin time <= 1.5 X ULNXx_NEWLINE_xXProthrombin time (PT)/International normalized ratio (INR) and partial thromboplastin time (PTT) <=1.3xULNXx_NEWLINE_xXCoagulation parameters: International normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULNXx_NEWLINE_xXInternational normalized ratio (INR) and partial thromboplastin time (PTT) </=1.5 times ULN (upper limit of normal)Xx_NEWLINE_xXThe subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening that are >= 1.3 x ULNXx_NEWLINE_xXPART I: Absolute neutrophil count (ANC), hemoglobin, platelet, total bilirubin, creatinine, transaminase (aspartate aminotransferase [AST]/alanine aminotransferase [ALT]), prothrombin time (PT), partial thromboplastin time (PTT), urine uric acid, urine pH, urine oxalate must be within standard normal rangesXx_NEWLINE_xXPT/INR and aPTT ? 1.5 ULN.Xx_NEWLINE_xXAdequate baseline organ function as defined by: absolute neutrophil count (ANC) >= 1.2 × 109/L; Hemoglobin >= 9 g/dL; Platelet count >= 100 x 109/L; prothrombin time (PT) / international normalized ratio (INR) and partial thromboplastin time (PTT) <= 1.5 x upper limit of normal (ULN); Albumin >= 2.5 g/dL; Total bilirubin <= 1.5 x ULN; aspartate aminotransferase (AST) and alanine transaminase (ALT) <= 2.0 x ULN; Creatinine <=1.5 mg/mL; Left Ventricular Ejection fraction (LVEF) >= lower limit of normal (LLN) by ECHOXx_NEWLINE_xXPartial thromboplastin time (PTT) > 80Xx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN)Xx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) ? 1.2 x the upper limit of normal (ULN) unless receiving anticoagulation therapy. If receiving anticoagulation therapy, eligibility will be based upon International Normalization Ratio (INR)Xx_NEWLINE_xXPartial thromboplastin time ? 1.5 X upper limitXx_NEWLINE_xXActivated partial thromboplastin time (APTT)/partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXPartial thromboplastin time (PTT) or activated (a)PTT =< 1.5 x upper limit of normal (ULN) per institutional laboratory rangeXx_NEWLINE_xXProthrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x institutional upper limit of normal (IULN)Xx_NEWLINE_xXInternational normalized ratio (INR) < 1.5 and a partial thromboplastin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate; for patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly (INR must be therapeutic in the range of 2-3)Xx_NEWLINE_xXProthrombin time (PT) =< 4 seconds above upper limit of normal (ULN) and partial thromboplastin time (PTT) =< 10 seconds above ULNXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institutionXx_NEWLINE_xXInternational normalized ratio (INR) < 1.5 or a prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits; patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate; for patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stableXx_NEWLINE_xXPartial thromboplastin time (PTT) < 1.2 times the upper limit of normalXx_NEWLINE_xXProthrombin time (PT) or partial thromboplastin time (PTT) > 1.5 x the upper limit of normal, except if the patient is on therapeutic anticoagulation, in which case they should demonstrate stability of PT/PTT for at least two weeksXx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.2 X ULNXx_NEWLINE_xXProthrombin time (PT) < 1.5 ULNXx_NEWLINE_xXThe participant either has adequate coagulation function as defined by international normalized ratio (INR) ? 1.5 and partial thromboplastin time (PTT) no more than 5 seconds above the ULN, or is on a stable dose of anticoagulantXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT) =< 1.5 x ULNXx_NEWLINE_xXActivated partial thromboplastin time =< 1.5 times ULNXx_NEWLINE_xXActivated partial thromboplastin time =< 1.5 times ULNXx_NEWLINE_xXProthrombin time (PT) such that the international normalized ratio (INR) is less than or equal to 1.2 x ULN (institutional upper limit of normal) (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and a partial thromboplastin time (PTT) less than or equal to 1.2 x ULN; subjects receiving anticoagulant therapy are eligible if their INR is stable and PT/PTT therapeutic and within the recommended range for the desired level of anticoagulationXx_NEWLINE_xXProthrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.2 X upper limit of normal (ULN)Xx_NEWLINE_xXInternational normalized ratio (INR) of prothrombin time (PT; PT-INR) and activated partial thromboplastin time (aPTT) =< 1.5: subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists per medical history; close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of careXx_NEWLINE_xXPartial thromboplastin time (PTT) within normal limits (WNL)Xx_NEWLINE_xXProthrombin time > 1.5 x controlXx_NEWLINE_xXHave a bleeding disorder as determined by prothrombin time (PT) > 14.5 seconds, partial thromboplastin time (PTT) > 34 seconds, and platelet count < 140,000 platelets per microliter of circulating blood1Xx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) > 1.5 x ULNXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) ? 1.3 × ULNXx_NEWLINE_xXAbnormal coagulation (partial thromboplastin [PT] or activated partial thromboplastin time [aPTT] > 30% above normal limits)Xx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin (PTT) =< 1.5 x IULNXx_NEWLINE_xXPartial thromboplastin time (PTT) =< 60Xx_NEWLINE_xXWithin 30 days of surgery: Activated partial thromboplastin time (aPTT) =< 40Xx_NEWLINE_xXPartial thromboplastin time (PTT) < 1.5 times the upper limit of normal (heparin, lovenox or alternative anticoagulants are acceptable)Xx_NEWLINE_xXActivated partial thromboplastin time (APTT) or partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXEvidence of bleeding diathesis or coagulopathy (partial thromboplastin time [PTT] and/or either prothrombin time [PT] or international normalized ratio [INR] > 1.5 x upper limit of normal) (except for subjects receiving anti-coagulation therapy); concurrent use of Coumadin or warfarin will be acceptable and monitoring patients on warfarin or Coumadin will follow the standard of care as dictated by the prescribing physician (PT/PTT); if the prescribing physician is not a Moffitt medical doctor (MD), then the prescribing MD will be notified by the research staff of the subject participating in the study, and monitors for PT, PTT will be obtained from patient during the 3 month study visit for reviewXx_NEWLINE_xXProthrombin time (PT)/activated partial thromboplastin time (aPTT) =< 1.5 x institutional upper limit of normal (ULN) for ageXx_NEWLINE_xXInternational normalized ratio (INR)/ partial thromboplastin time (PTT) =< 1.5 x ULNXx_NEWLINE_xXInternational normalized ratio (INR) and activated partial thromboplastin time (aPTT) </= 2 x ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULNXx_NEWLINE_xXInternational Normalized Ratio (INR) ?1.5 and a partial thromboplastin time (PTT) ?5 seconds above the ULN.Xx_NEWLINE_xXPartial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) =< 1.5 times the upper limit of normalXx_NEWLINE_xXAn international normalized ratio (INR) > 1.6, or a partial thromboplastin time (PTT) > 40 secondsXx_NEWLINE_xXActivated partial thromboplastin time (aPTT) =< 40 (within 30 days of surgery)Xx_NEWLINE_xXSubjects unable to undergo routine endoscopy with biopsy:\r\n* Women who are pregnant or breastfeeding\r\n* Prothrombin time < 50% of control; partial thromboplastin time (PTT) > 50 sec, or international normalized ratio (INR) > 2.0\r\n* Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other significant medical issuesXx_NEWLINE_xXPartial thromboplastin time (PTT) greater than 50 seconds (sec) or international normalized ratio (INR) greater than 2.0Xx_NEWLINE_xXInternational normalized ratio (INR) > 1.4 and activated partial thromboplastin time (aPTT) > 3 seconds above the upper limit of normal for age, within 1 week prior to enrollment.Xx_NEWLINE_xXProthrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXScreening laboratory values (serum chemistry, hematology, prothrombin time [PT](international normalized ratio [INR])/activated partial thromboplastin time [APTT], and creatine phosphokinase [CPK]) obtained up to 28 days prior to administration of first vaccine injection on day 0 within institutional normal range or judged to be not clinically significant by principal investigator (PI) and medical monitorXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) within normal institutional limitsXx_NEWLINE_xXPresence of coagulopathy (prothrombin time [PT] or partial thromboplastin time [PTT] > 1.2 x upper limit of normal)Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) (activated partial thromboplastin time [aPTT]) =< 1.5 x upper limit of normalXx_NEWLINE_xXThrombin time (TT), prothrombin time (PT), or partial thromboplastin time (PTT) > 2 x upper limit of normalXx_NEWLINE_xXPrior anticoagulant therapy use is allowed provided therapy is discontinued at least 7 days prior to the breast biopsy in order to reduce the risk of bleeding. For participants who have taken an anticoagulation within the past 7 days, international normalized ratio must be ? 1.5 x institutional upper limit of normal and prothrombin time and partial thromboplastin time ? ULN prior to the breast biopsy.Xx_NEWLINE_xXActivated partial thromboplastin time (aPTT) within normal institutional limitsXx_NEWLINE_xXPatients not taking warfarin must have prothrombin time (PT)/partial thromboplastin time (PTT) levels =< 1.5 times the upper limit of normal provided by the reference laboratory performing the testXx_NEWLINE_xXActivated partial thromboplastin time (APTT)/partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normalXx_NEWLINE_xXInternational Normalized Ratio (INR) and activated Partial Thromboplastin Time [PTT] within normal institutional limitsXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULNXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 times institutional upper limit of normalXx_NEWLINE_xXProthrombin time (PT) < 1.5 × ULN or international normalized ratio (INR) < 1.3 and partial thromboplastin time (PTT) < 1.5 × ULN; unless the patient is on a therapeutic anticoagulantXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) within normal institutional limitsXx_NEWLINE_xXPartial thromboplastin time (PTT) =< 2 x upper limit of normal (ULN)Xx_NEWLINE_xXPTT (partial thromboplastin time) =< 1 x ULNXx_NEWLINE_xXPT/PTT/INR (prothrombin time/partial thromboplastin time) without clinically significant abnormalities after review by the study physiciansXx_NEWLINE_xXContraindication to biopsy:\r\n* Bleeding disorders\r\n* Prothrombin time (PT)/partial thromboplastin time (PTT) >= 1.5 times the upper limit of normal\r\n* Artificial heart valveXx_NEWLINE_xXPatients with coagulopathies who are at increased risk for bleeding or on active anti-coagulation therapy (platelets less than 100,000 per mm^3 or prothrombin time [PT]/partial thromboplastin time [PTT] greater than 1.5 times the upper normal limit [UNL]); patients are eligible if the underlying cause is correctableXx_NEWLINE_xXPartial thromboplastin time less than 4.0 times below or above the upper or lower limit rangeXx_NEWLINE_xXPartial thromboplastin time (PTT) =< 1.2 X ULN (evaluated within 28 days of randomization)Xx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x institutional upper limit of normal (within 14 days of study registration)Xx_NEWLINE_xXActivated partial thromboplastin time (aPTT) and prothrombin time (PT) not to exceed 1.5 x upper limit of normal (ULN), completed within 2 weeks prior to start of protocol therapyXx_NEWLINE_xXProthrombin time (PT)/partial thromboplastin time (PTT) =< the institution ULNXx_NEWLINE_xXPT/PTT > the institution ULNXx_NEWLINE_xXProthrombin time > 1.5 x controlXx_NEWLINE_xXPatients with abnormal prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) or bleeding diathesisXx_NEWLINE_xXProthrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.2 X upper limit of normal (ULN)Xx_NEWLINE_xXCoagulopathy (prothrombin time [PT] or partial thromboplastin time [PTT] > 1.5 x upper limit of normal)Xx_NEWLINE_xXinternal normalized ratio and partial thromboplastin time <1.5x upper limit of normalXx_NEWLINE_xXThe patient has adequate coagulation: prothrombin time (PT), partial thromboplastin time (PTT), and an International Normalized Ratio within normal limits.Xx_NEWLINE_xXActivated partial thromboplastin time (aPTT) or plasma thromboplastin (PT) outside the institution's standard of care.Xx_NEWLINE_xXProthrombin time (PT), partial thromboplastin time (PTT) =< 1.5 times upper limit of normalXx_NEWLINE_xX