Patients who have had or are planning to have the following invasive procedures are not eligible:\r\n* Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment\r\n* Subcutaneous port placement or central line placement is not considered major surgery; external central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollment\r\n* Core biopsy within 7 days prior to enrollment\r\n* Fine needle aspirate within 7 days prior to enrollment\r\n* NOTE: For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy
Patients who have had or are planning to have the following invasive procedures are not eligible:\r\n* Major surgical procedure, laparoscopic procedure, or open biopsy within 28 days prior to enrollment\r\n* Central line placement or subcutaneous port placement is not considered major surgery but must be placed at least 3 days prior to enrollment for external lines (e.g., Hickman or Broviac catheter, peripherally inserted central catheter [PICC]) and at least 7 days prior to enrollment for a subcutaneous port\r\n* Core biopsy within 7 days prior to enrollment\r\n* Fine needle aspirate within 7 days prior to enrollment\r\n* Surgical or other wounds must be adequately healed prior to enrollment\r\n* NOTE: For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy
Patients who have had or are planning to have the following invasive procedures will be excluded:\r\n* Major surgical procedures, laparoscopic procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 therapy; subcutaneous port placement or central line placement is not considered major surgery, but must be placed greater than 48 hours from planned day 1 of therapy\r\n* Core biopsy within 7 days prior to day 1 therapy\r\n* Fine needle aspirate or central line placement within 48 hours prior to day 1 therapy\r\nNote: Routine bone marrow aspirate and biopsy for the purposes of disease staging are not part of these exclusion guidelines
Patients who have undergone major surgery within 28 days or subcutaneous venous access device placement within 7 days prior to study enrollment
Minor surgery/subcutaneous venous access device placement within 7 days prior to first dose of protocol therapy
Patients who have had or are planning to have the following invasive procedures will be excluded- Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1 therapy (Subcutaneous port placement or central line placement is not considered major surgery but must be placed greater than 48 hours from planned Day 1 of therapy); Core biopsy within 7 days prior to Day 1 therapy; Fine needle aspirate or central line placement within 48 hours prior to Day 1therapy.
Patients who have had or are planning to have the following invasive procedures are not eligible:\r\n* Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment\r\n* Central line placement or subcutaneous port placement is not considered major surgery; external central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollment\r\n* Core biopsy within 7 days prior to enrollment\r\n* Fine needle aspirate within 7 days prior to enrollment\r\n* Surgical or other wounds must be adequately healed prior to enrollment; Note: for purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy
Central line placement or subcutaneous port placement is not considered major surgery but must be placed at least 2 days prior to study drug administration.
Patients who have had or are planning to have the following invasive procedures are not eligible:\r\n* Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 14 days prior to initiation of protocol therapy; there should be no anticipation of need for major surgical procedures during the course of the study\r\n* Central line placement or subcutaneous port placement is not considered major surgery; external central lines must be placed at least 3 days prior to initiation of protocol therapy and subcutaneous ports must be placed at least 7 prior to initiation of protocol therapy
The patient has undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment
The patient has undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment
Have had major surgery within 21 days of starting therapy. Placement of a venous access device within 21 days of starting therapy is allowed.
The patient has undergone major surgery within 28 days prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 2 days prior to first dose of protocol therapy; the patient has elective or planned major surgery to be performed during the course of the clinical trial
Central line placement or subcutaneous port placement is not considered major surgery but must be placed at least 2 days prior to study drug administration
Patients who have had or are planning to have the following invasive procedures are not eligible:  \r\n* Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment\r\n* Central line placement or subcutaneous port placement is not considered major surgery but must be placed at least 3 days prior to enrollment for external lines (e.g. Hickman or Broviac) and at least 7 days prior to enrollment for subcutaneous port\r\n* Core biopsy within 7 days prior to enrollment\r\n* Fine needle aspirate within 7 days prior to enrollment\r\n* NOTE: for purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy
Patients who have had or are planning to have the following invasive procedures are not eligible:\r\n* Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment\r\n* Subcutaneous port placement or central line placement is not considered major surgery; external central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollment\r\n* Core biopsy within 7 days prior to enrollment\r\n* Fine needle aspirate within 7 days prior to enrollment\r\n* NOTE: for purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy
No major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization
Patients who have elective or planned major surgery to be performed during the course of the clinical trial; minor surgery/subcutaneous venous access device placement within 7 days prior to first dose of protocol therapy is permitted
Have undergone major surgery within 28 days (?28 days) prior to randomization or subcutaneous venous access device placement within 7 days (?7 days) prior to randomization.
Minor surgical procedure(s) within 7 days of enrollment or randomization, or not yet recovered from prior surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent ? 1 day before enrollment or randomization is acceptable)
have experienced any of the following: a major surgical procedure, significant traumatic injury, non-healing wound, peptic ulcer, or bone fracture less than or equal to 28 days prior to enrollment, or placement of a subcutaneous venous access device less than or equal to 7 days prior to the first dose of study treatment unless the procedure is of low risk of bleeding in the judgment of the investigator
Have undergone major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to first dose of study treatment, except if the procedure is minimally invasive (for example, introduction of peripherally inserted central catheter [PICC] line) and the investigator does not anticipate any significant bleeding.
Undergone major surgery within 28 days prior to first dose of study drug or have subcutaneous venous access device placement within 7 days prior to first dose. Additional Exclusion Criteria For Part D
The participant underwent major surgery within 28 days prior to randomization or central venous access device placement within 7 days prior to randomization.
Central line placement or subcutaneous port placement is not considered major surgery. External central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollment.
Recent major surgery within the prior 4 weeks; (mediastinoscopy or placement of a central venous access will be allowed as long as placement was more than 7 days prior to receiving study drug)
Minor surgical procedures except placement of tunneled central venous access device within 3 days prior to enrollment
The participant has undergone major surgery within 28 days prior to randomization or has undergone central venous access device placement within 7 days prior to randomization
No major surgery within 30 days prior to registration for protocol therapy. Placement of a venous access device within 30 days prior to registration for protocol therapy is allowed.
Minor surgical procedure(s) within 7 days of enrollment or not yet recovered from prior minor surgery (placement of central venous access device, fine needle aspiration, or endoscopic biliary stent ? 1 day before enrollment is acceptable)
Minor surgical procedures, placement of tunneled central venous access device within 3 days prior to randomization/enrollment
Has undergone major surgery within 4 weeks prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization
Major surgery within 28 days prior the first dose of study medication, or subcutaneous venous access device placement within 7 days prior to randomization
Placement of a subcutaneous venous access device within 7 days prior to the first dose of study treatment unless the procedure is judged of low risk of bleeding.
Major surgery [excluding Central Venous Access Device (CVAD) replacement and bone marrow aspiration and non-open biopsy] within the last 7 days prior to enrollment that may be associated with a risk of bleeding. Open biopsy is considered a major surgery.