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) Prothrombin time (PT)/ international normalized ration (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN Patients 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 assessment Prothrombin 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 randomization International normalized ratio (INR) < 1.5; partial thromboplastin time (PTT) < 1.5 upper limit of normal (ULN); d-dimer < 250ng/mL Patients must have adequate coagulation (international normalized ratio (INR) or prothrombin time (PT), partial thromboplastin time (PTT) ?1.5 times ULN) Prothrombin 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 subjects The 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 cabozantinib Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN) Prothrombin 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 ULN International normalized ratio (INR) =< 1.5 and partial thromboplastin time (PPT) =< 5 seconds above the upper limit of normal (ULN) The 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 treatment Prothrombin 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]). Prothrombin 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 normal Adequate 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. The 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 treatment Adequate coagulation function, defined by prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT), or thrombin time (TT) of ?1.5 × ULN Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN International 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. Prothrombin 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) The 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), PHASE I: Prothrombin time (PT) (or international normalized ratio [INR]) and partial thromboplastin time (PTT) =< 1.5 x ULN International normalized ratio (INR)/partial thromboplastin time (PTT) has to be =< 1.5 x ULN Prothrombin time (PT) or international normalized ratio (INR) and a partial thromboplastin time (PTT) > 1.5 times the upper limit of normal Subject has prothrombin time/International Normalized Ratio or partial thromboplastin time test results at screening ?1.5 x ULN. Prothrombin time (PT) or international normalized ratio (INR), partial thromboplastin time (PTT) =< 1.5 x ULN Adequate coagulation function as defined by International Normalized Ratio ?1.5 or prothrombin time ?1.5 x ULN, and partial thromboplastin time ?1.5 x ULN Coagulation parameters: international normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN Prothrombin time (PT)/ international normalized ratio (INR), partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN) Prothrombin 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. Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test =< 1.5 x ULN Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 x upper limit of normal (ULN). Prothrombin time (PT)/institutional normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) Within 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 treatment Prothrombin 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). The 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 treatment International normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN International normalized ratio (INR) and activated partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN) provided the patient is not on anticoagulation therapy International normalized ratio (INR)/partial thromboplastin time (PTT) =< 1.5 x ULN; unless patient is on therapeutic anticoagulation Prothrombin 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 assignment Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) Prothrombin time/international normalized ratio (PT/INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 X upper limit of normal (ULN) FULL 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 discretion Serum coagulation studies (international normalized ratio [INR]/partial thromboplastin time [PTT]) and platelet counts suitable for surgery per surgeon discretion Prothrombin time (PT)/ international normalized ratio (INR) and partial thromboplastin time (PTT) test =< 1.3 ULN Prothrombin 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. Abnormal coagulation parameters (prothrombin time [PT] > 15 seconds, partial thromboplastin time [PTT] > 40 seconds, and/or international normalized ratio [INR] > 1.5) Prothrombin time (PT)/international normalized ration (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN Prothrombin 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 ULN For 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 normal International normalized ratio (INR) =< 1.5 or prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits (WNL) of the institution The 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 treatment Prothrombin 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 ULN Prothrombin 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 randomization 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 treatment Blood 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 normal Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN The 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 treatment Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.2 x institutional ULN The 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 treatment Normal blood coagulation as evidenced by partial thromboplastin time (PTT) < 1.5 IULN and international normalized ratio (INR) < 1.5 Abnormal 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) Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x institutional ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x institutional ULN Prothrombin time (PT)/international normalized ratio (INR); partial thromboplastin time (PTT) =< 1.3; =< 1.3 x ULN Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN for age Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) ? 1.5 x ULN (except for subjects receiving anticoagulation therapy) International 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 range Within 14 days prior to first dose of study drug treatment: International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULN The 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 treatment INR (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.) Prothrombin 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 ULN Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) Prothrombin 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 ULN Serum 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 PI The 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 treatment Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN), OR international normalized ratio (INR) < 1.5 International normalized ratio (INR) or partial thromboplastin time (PTT)/prothrombin time (PT) =< 1.5 ULN, unless the patient is on stable therapeutic dose of warfarin International normalized ratio INR/ prothrombin time (PT)/ partial thromboplastin time (PTT) each < 1.5 x ULN Prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN Prothrombin 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 normal Prothrombin 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 The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 x the laboratory ULN Active 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 screening Prothrombin 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-coagulation Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN Prothrombin 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 treatment Prothrombin 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 International normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x ULN Prothrombin 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) Prothrombin 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 anticoagulation Prothrombin 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 ULN International normalized ratio ?1.5 × ULN and partial thromboplastin time ?5 seconds above ULN. Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN Only for patients who test positive for hepatitis B virus or hepatitis C virus: partial thromboplastin time (PTT)/international normalized ratio (INR) =< ULN (institutional) Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 upper limit of normal (ULN) Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN. Prothrombin time (PT), partial thromboplastin time (PTT) and international normalized ratio (INR) =< 1.5 upper limit of normal (ULN) Other: INR (prothrombin time ratio) or partial thromboplastin time (PTT) >1.5 x ULN Coagulation parameters: international normalized ratio (INR) =< 2, prothrombin time (PT) and partial thromboplastin time (PTT) < 1.5 X institutional ULN Normal prothrombin time (PT)/international normalized ratio (INR) and partial prothrombin time (PTT) Subjects with coagulopathies, including thrombocytopenia with platelet count < 75,000, international normalized ratio (INR) > 1.5 and partial thromboplastin time > 50 sec Prothrombin 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 parameters Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 x ULN The 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 treatment Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.5 x upper limit of normal (ULN), OR international normalized ratio (INR) < 1.5 The 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 anticoagulated Prothrombin time/international normalized ratio (INR) and partial thromboplastin time within normal limits Prothrombin 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 performed No patients will have coagulation parameters: international normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% deviation of the institutional ULN Prothrombin 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 range Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) < 1.5 x ULN Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 X upper limit of normal (ULN) International normalized ratio (INR) > 1.6 and a partial thromboplastin time (PTT) > 40 seconds Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN International normalized ratio (INR) < 2, prothrombin time (PT) < 20 sec, and partial thromboplastin time (PTT) < 55 sec Adequate coagulation system defined as an international normalized ratio (INR) of less than 1.4 and a partial thromboplastin time (PTT) of less than 34 The 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) Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional upper limit of normal (ULN) Prothrombin 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 cohorts Prothrombin 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) The 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 treatment The participant has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 X the laboratory ULN Prothrombin 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 ULN Prothrombin 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 anticoagulation International 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) The 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 registration active, 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); International 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) Patients 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) Subjects 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) International normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN International normalized ratio (INR)/ partial thromboplastin time (PTT) =< 1.5 x ULN Normal partial thromboplastin time (PTT) and either international normalized ratio (INR) or prothrombin time (PT) < 1.5 x ULN Prothrombin time (PT)/partial thromboplastin time (PTT)/international normalized ratio (INR) =< 1.5 upper limit of normal (ULN) The 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 treatment The subject has prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) test results at screening >= 1.3 x the laboratory ULN Patients 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 randomization International 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 TPI 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) Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.3 upper limit of normal (ULN) The 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 treatment The 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 normal Prothrombin time (PT)-international normalized ratio (INR)/partial thromboplastin time (PTT) < 1.5 x ULN except in patients receiving active anticoagulation International Normalized Ratio (INR) and activated partial thromboplastin time [PTT] ? 1.5×ULN, if not therapeutically anticoagulated. Coagulation parameters: International normalised ratio (INR) < 2 and partial prothrombin Time (PTT) = 2xULN Patients must have prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) within 1.2 x the upper limit of normal Prothrombin time (PT)/International normalized ratio (INR) and partial thromboplastin time (PTT) <=1.3xULN Coagulation parameters: International normalized ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 50% of deviation of institutional ULN International normalized ratio (INR) and partial thromboplastin time (PTT) = 1.3 x ULN Prothrombin 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) The 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 anticoagulant Prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT) =< 1.5 x ULN Prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.2 X upper limit of normal (ULN) Evidence 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 review International normalized ratio (INR)/ partial thromboplastin time (PTT) =< 1.5 x ULN Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN International Normalized Ratio (INR) ?1.5 and a partial thromboplastin time (PTT) ?5 seconds above the ULN. An international normalized ratio (INR) > 1.6, or a partial thromboplastin time (PTT) > 40 seconds Subjects 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 issues Partial thromboplastin time (PTT) greater than 50 seconds (sec) or international normalized ratio (INR) greater than 2.0 Prior 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. Subjects with coagulopathies, including thrombocytopenia with platelet count < 75,000, international normalized ratio (INR) > 1.5 and partial thromboplastin time > 50 sec International Normalized Ratio (INR) and activated Partial Thromboplastin Time [PTT] within normal institutional limits Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 x institutional ULN Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.5 times institutional upper limit of normal Prothrombin 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 anticoagulant Prothrombin 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) Patients with abnormal prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) or bleeding diathesis Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =< 1.2 X upper limit of normal (ULN) The patient has adequate coagulation: prothrombin time (PT), partial thromboplastin time (PTT), and an International Normalized Ratio within normal limits.