Received oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXReceived oral or intravenous (IV) antibiotics within 2 weeks prior to randomization; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXActive infection or chronic infection requiring chronic suppressive antibioticsXx_NEWLINE_xXActive infection requiring treatment with antibioticsXx_NEWLINE_xXReceived oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXReceived oral or intravenous (IV) antibiotics within 14 days prior to randomization; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXPatients must not have a serious intercurrent illness, including ongoing or active infection requiring parental antibioticsXx_NEWLINE_xXPatients must not have an active infection requiring oral or IV antibiotics within 14 days prior to registration; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXPatient has an infection requiring treatment with systemic antibiotics or antiviral medication or has completed treatment for such an infection within 14 days prior to planned first dose of study drugXx_NEWLINE_xXActive infection requiring intravenous (IV) antibioticsXx_NEWLINE_xXActive infection requiring parenteral or oral antibiotics within 2 weeks before planned start of study therapyXx_NEWLINE_xXActive infection requiring intravenous antibiotics within 1 week of study enrollment (day 1).Xx_NEWLINE_xXKnown active infection requiring parenteral or oral anti-infective treatment within 14 days of randomization.Xx_NEWLINE_xXSerious infection requiring antibiotics within 2 weeks prior to randomization, including but not limited to infections requiring hospitalization or IV antibiotics, such as bacteremia, or severe pneumoniaXx_NEWLINE_xXActive infection requiring intravenous antibiotics at cycle 1 day 1Xx_NEWLINE_xXActive infection or chronic infection requiring chronic suppressive antibiotics.Xx_NEWLINE_xXSubject has an uncontrolled active infection requiring treatment and fever 38.3°C or higher 48 hours before the first dose of study drug. Controlled infections (i.e. 3 negative cultures completing antibiotics and/or stable fungal infection in therapy) are allowed provided the subject has a temperature of < 38.3°C within 48 hours of the first dose of study drug.Xx_NEWLINE_xXReceived oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXCurrent infection requiring parenteral antibioticsXx_NEWLINE_xXActive systemic infection requiring intravenous antibiotics within 2 weeks of treatment startXx_NEWLINE_xXAcute infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first doseXx_NEWLINE_xXActive infections requiring antibiotics, physician monitoring or recurrent fevers >100.4?F (38.0?C) associated with a clinical diagnosis of active infectionXx_NEWLINE_xXPatients with any unstable medical issue (including cardiac issues as above, active treatment for symptomatic pulmonary embolism, cerebrovascular accident [CVA], renal or hepatic insufficiency, active infection/sepsis requiring intravenous [IV] antibiotics)Xx_NEWLINE_xXOngoing or active infection; the requirement for intravenous (IV) antibiotics is considered active infectionXx_NEWLINE_xXKnown active infection requiring parenteral or oral anti-infective treatment, once a patient has completed antibiotics and symptoms of infection have resolved to < grade 2, they are then considered eligible from an infection standpointXx_NEWLINE_xXActive infection requiring IV antibiotics at day 1 of cycle 1Xx_NEWLINE_xXAcute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior cycle 1, day 1Xx_NEWLINE_xXActive infection requiring parenteral antibiotics within 2 weeks before planned first dose of study drugXx_NEWLINE_xXActive infection requiring IV antibiotics within 2 weeks of study doseXx_NEWLINE_xXNo active infection requiring antibioticsXx_NEWLINE_xXHas an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection.Xx_NEWLINE_xXSystemic infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of registrationXx_NEWLINE_xXSerious/active infection or infection requiring parenteral antibioticsXx_NEWLINE_xXPatients with active infection requiring antibiotics are not eligible (with the exception of uncomplicated UTI and uncomplicated respiratory tract infections)Xx_NEWLINE_xXOngoing active infection; the requirement for intravenous (IV) antibiotics is considered active infectionXx_NEWLINE_xXPatients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])Xx_NEWLINE_xXAcute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first doseXx_NEWLINE_xXAcute active infection requiring systemic antibiotics, antivirals, or antifungals within 14 days prior to first doseXx_NEWLINE_xXActive infection requiring antibioticsXx_NEWLINE_xXActive infection requiring iv antibiotics at day 1 of cycle 1Xx_NEWLINE_xXReceived oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXPatients who are otherwise ineligible to receive the antibiotics in this studyXx_NEWLINE_xXTreatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment, except prophylactic antibioticsXx_NEWLINE_xXActive infection (infection requiring intravenous antibiotics)Xx_NEWLINE_xXEXCLUSION - PROCUREMENT: Active infection requiring antibioticsXx_NEWLINE_xXThe patient has any ongoing or active infection, including active tuberculosis; Note: a urinary tract infection controlled with oral antibiotics initiated at least 7 days prior to study entry is acceptableXx_NEWLINE_xXActive infection requiring intravenous (IV) antibiotics within 14 days before Day 1, Cycle 1Xx_NEWLINE_xXActive infection requiring intravenous antibiotics at week 1 day 1Xx_NEWLINE_xXSerious infection requiring oral or IV antibiotics/antifungals/antivirals and/or hospitalization within 28 days prior to screening\r\n* Patients on prophylactic oral antibiotics, antifungals and antivirals due to prolonged neutropenia in the absence of documented infection are eligible\r\n* Patients who are treated with IV antibiotics for neutropenic fever, are eligible if no infectious etiology was determined and the last dose of antibiotics was >= 7 days from cycle 1, day 1Xx_NEWLINE_xXMust be free of systemic infection; subjects with active infections (whether or not they require antibiotic therapy) may be eligible after complete resolution of the infection; subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatmentXx_NEWLINE_xXInfection requiring intravenous antibiotic therapy or other serious infection within 14 days before study enrollmentXx_NEWLINE_xXMust be free of systemic infection; subjects with active infections (whether or not they require antibiotic therapy) may be eligible after complete resolution of the infection; subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatmentXx_NEWLINE_xXReceived oral or intravenous (IV) antibiotics within 2 weeks prior to Cycle 1, Day 1. Participants receiving prophylactic antibiotics (for prevention of a urinary tract infection chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXActive infection requiring IV antibiotics on Cycle 1, Day 1Xx_NEWLINE_xXInfection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before randomization.Xx_NEWLINE_xXCurrent infection requiring parenteral antibioticsXx_NEWLINE_xXPatients with active infection will not be eligible, but may become eligible once infection has resolved and they are at least 7 days from completion of antibioticsXx_NEWLINE_xXActive infection requiring IV anti-infective usage within the last 7 days prior to study treatment.Xx_NEWLINE_xXIf they have a major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drugXx_NEWLINE_xXPatients should not have any evidence of active or uncontrolled infection requiring treatment with antibioticsXx_NEWLINE_xXCurrently using antibiotics and/or anti fungal agent (however, topical antibiotics are permitted).Xx_NEWLINE_xX=< 14 days before first dose of protocol-indicated treatment:\r\n* Anti-cancer therapy with an approved or investigational agent (including chemotherapy, hormonal therapy, targeted therapy, immunotherapy, or biological therapy).\r\n* Radiosurgery or radiotherapy. (Note: A tumor lesion situated in a previously irradiated area is considered a measurable/target lesion only if subsequent disease progression has been documented in the lesion.)\r\n* Initiation of a new erythropoietin, darbepoietin, and/or bisphosphonate therapy.\r\n* Minor surgery. (Note: Placement of a vascular access device is not considered minor or major surgery.)\r\n* Serious or uncontrolled infection.\r\n* Infection requiring parenteral antibiotics. (Note: Patients with a non-serious infection under active treatment and controlled with oral antibiotics initiated at least 10 days prior to initiation of protocol-indicated treatment are not excluded – e.g. urinary tract infection controlled with oral antibiotics.)\r\n* Unexplained fever > 38.0 degree Celsius (C).Xx_NEWLINE_xXActive serious infection not controlled by oral or intravenous antibioticsXx_NEWLINE_xXSystemic infection requiring intravenous (IV) antibiotic or antifungal or antiviral therapy within 7 days preceding the first dose of study drug, or other severe infectionXx_NEWLINE_xXReceived therapeutic oral or IV antibiotics within 2 weeks prior to Day 0;Xx_NEWLINE_xXChronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis CXx_NEWLINE_xXKnown active infection requiring parenteral or oral anti-infective treatment within 14 days of initiation of therapyXx_NEWLINE_xXClinically significant active infection requiring intravenous antibiotics (=< 14 days prior to registration)Xx_NEWLINE_xXMust be free of systemic infection:\r\n* Subjects with active infections (whether or not they require antibiotic therapy) may be eligible after complete resolution of the infection\r\n* Subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatmentXx_NEWLINE_xXTherapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to first day of study treatment:\r\n* Patients receiving prophylactic antibiotics (eg, to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligibleXx_NEWLINE_xXHave a chronic or active infection that requires systemic antibiotics, antifungal or antiviral treatmentXx_NEWLINE_xXActive infection requiring systemic antibiotics or antifungals within 7 days prior to first dose of study drug; exception: tetracycline family antibiotics (tetracycline, doxycycline, minocycline) administered for the management of cetuximab-related rash may be continued per the investigator’s judgmentXx_NEWLINE_xXCurrent infection requiring parenteral antibioticsXx_NEWLINE_xXActive infection requiring intravenous antibiotics (must be completed prior to registration)Xx_NEWLINE_xXHas an uncontrolled infection requiring IV antibiotics, antivirals, or antifungalsXx_NEWLINE_xXGENERAL: Received oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1.\r\n* Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible.Xx_NEWLINE_xXCurrently with an active acute infection, or suspected infection, a single oral temperature of ? 101° F or a temperature of ? 100.4°F sustained over a 1 h period in past 24 h. Subjects on prophylactic antibiotics are not excluded from studyXx_NEWLINE_xXReceived oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXUncontrolled infection requiring systemic antibiotics/antivirals/antifungalsXx_NEWLINE_xXSevere infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.Xx_NEWLINE_xXRecent or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment within 2 weeks prior to the start of study drugXx_NEWLINE_xXReceived oral or IV antibiotics within 2 weeks prior to start of study treatment.\r\n* Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligible.Xx_NEWLINE_xXActive infection requiring the use of systemic antibioticsXx_NEWLINE_xXParticipant has an active infection requiring IV antibioticsXx_NEWLINE_xXConcomitant therapy that includes other chemotherapy that is or may be active against AML except for prophylaxis and/or treatment of opportunistic or other infection with antibiotics, antifungals and/or antiviral agents.Xx_NEWLINE_xXInfection requiring intravenous antibiotics that was completed < 1 week of study enrollment (day 1) with the exemption of prophylactic antibiotics for long line insertion or biopsyXx_NEWLINE_xXActive infection requiring systemic antibiotics within 2 weeks prior to cycle 1, day 1; prophylactic short-term antibiotics will be allowedXx_NEWLINE_xXPatients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])Xx_NEWLINE_xXActive infection requiring antibiotics (with the exception of uncomplicated urinary tract infection)Xx_NEWLINE_xXHave uncontrolled intercurrent illness including, but not limited to, an ongoing/active infection requiring parenteral antibiotics.Xx_NEWLINE_xXReceived therapeutic oral or IV antibiotics within 2 weeks prior to first day of study treatment:\r\nPatients receiving prophylactic antibiotics (eg, to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligibleXx_NEWLINE_xXActive infection (requiring oral or intravenous antibiotics or antiviral therapy).Xx_NEWLINE_xXActive serious infection not controlled by oral or intravenous antibiotics.Xx_NEWLINE_xXWithin 14 days before first dose of protocol-indicated treatment:\r\n* Active uncontrolled infection; patients with infection under active treatment and controlled with antibiotics initiated at least 14 days prior to initiation of protocol-indicated treatment are not excluded (e.g. urinary tract infection controlled with antibiotics)Xx_NEWLINE_xXReceived oral or IV antibiotics for an infection within 2 weeks prior to the first study treatment. Subjects receiving prophylactic antibiotics are eligibleXx_NEWLINE_xXPatients with active systemic infections requiring intravenous antibiotics within 1 week prior to enrollmentXx_NEWLINE_xXTreatment with therapeutic oral or IV antibiotics within 14 days prior to initiation of study treatment; patients receiving prophylactic antibiotics (e.g. for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXReceived oral or IV antibiotics within 2 weeks prior to study treatment; but patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXActive infection requiring intravenous antibiotics (antibiotics should have been completed prior to registration)Xx_NEWLINE_xXReceived oral or IV antibiotics within 2 weeks prior to cycle 1, day 1 a) Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXSerious infection requiring parenteral antibiotic therapy or any other serious infection within 14 days before randomization.Xx_NEWLINE_xXOral or IV antibiotics within 2 weeks prior to enrollmentXx_NEWLINE_xXHas an active infection requiring systemic therapy with IV antibioticsXx_NEWLINE_xXActive serious infection not controlled by oral or intravenous antibiotics.Xx_NEWLINE_xXPresence of an serious illness, uncontrolled illness, or active infection requiring IV antibiotics.Xx_NEWLINE_xXReceived therapeutic oral or IV antibiotics within 1 week prior to cycle 1 day 1\r\n* Subjects receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive pulmonary disease exacerbation) are eligibleXx_NEWLINE_xXActive infection or chronic infection requiring chronic suppressive antibioticsXx_NEWLINE_xXUncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; however, prophylactic use of these agents is acceptable even if parenteralXx_NEWLINE_xXHave active infection requiring antibioticsXx_NEWLINE_xXActive infection requiring intravenous (IV) antibiotics or other uncontrolled intercurrent illness requiring hospitalization.Xx_NEWLINE_xXReceived oral or IV antibiotics =< 2 weeks prior to cycle 1, day 1\r\n* Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXReceived oral or IV antibiotics within 2 weeks prior to cycle 1, day 1\r\n* Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXInfection requiring intravenous antibiotic use within one week of enrollment.Xx_NEWLINE_xXHas active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) ? 10 days of C1D1Xx_NEWLINE_xXActive infection requiring parenteral antibioticsXx_NEWLINE_xXHas an active infection requiring systemic antibiotics within 10 days of registrationXx_NEWLINE_xXPatients should not be on antibiotics for any infection but post operative antibiotics are allowed if used prophylactically but should be completed prior to starting RTXx_NEWLINE_xXClinically significant active infection requiring intravenous antibiotics =< 14 days prior to registrationXx_NEWLINE_xXReceived oral or IV antibiotics within 2 weeks prior to cycle 1, day 1\r\n* Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXAcute infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first doseXx_NEWLINE_xXPatients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])Xx_NEWLINE_xXPatients with active infection will not be eligible, but may become eligible once infection has resolved and at least 7 days have relapsed after antibiotics use was completedXx_NEWLINE_xXActive clinically serious infections requiring antibiotics, antiviral or antifungal agents; participants must be off these agents for at least 28 days prior to the first dose of the study drugXx_NEWLINE_xXPatients with active infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study until resolution of the infection; patients on prophylactic antibiotics, antifungals or antivirals are acceptableXx_NEWLINE_xXChronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis CXx_NEWLINE_xXHIV infection, active Hepatitis B or C infection, or active infections requiring oral or intravenous antibiotics or that can cause a severe disease and pose a severe danger to lab personnel working on patients' blood or tissue. If positive test results are not indicative of an active infection, patients can be included.Xx_NEWLINE_xXActive infection requiring intravenous antibiotics or an unexplained febrile (> 101.5 degrees Fahrenheit [F]) illnessXx_NEWLINE_xXActive infection requiring antibiotics, antifungal or antiviral agents, that in the opinion of the investigator would compromise the patient’s ability to tolerate therapyXx_NEWLINE_xXKnown HIV-1 or any active infection requiring IV antibioticsXx_NEWLINE_xXSerious/active infection or infection requiring parenteral antibioticsXx_NEWLINE_xXActive infection requiring antibiotics or antifungals within 7 days prior to first dose of study drugXx_NEWLINE_xXTreatment with intravenous (systemic antibiotics, antivirals, or antifungals) within 14 days prior to start of treatmentXx_NEWLINE_xXPatients with acute hepatitis or active infection that requires parenteral antibioticsXx_NEWLINE_xXAny uncontrolled active systemic infection requiring intravenous (IV) antibioticsXx_NEWLINE_xXMajor systemic infection requiring antibiotics 72 hours or less prior to first dose of study drugXx_NEWLINE_xXHas active, serious infection requiring systemic therapy. Patients may receive prophylactic antibiotics and antiviral therapy at the discretion of the treating physician.Xx_NEWLINE_xXActive infection requiring intravenous (IV) antibiotic usage within the last week prior to study treatmentXx_NEWLINE_xXActive infection requiring IV antibiotics 7 days before enrollmentXx_NEWLINE_xXActive infection requiring intravenous antibioticsXx_NEWLINE_xXActive infection requiring parenteral antibioticsXx_NEWLINE_xXChronic or current active infectious disease requiring systemic antibiotics, antifungals, or antiviralsXx_NEWLINE_xXSubjects with an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis A, B or C infectionXx_NEWLINE_xXEvidence of ongoing or active infection requiring intravenous antibiotics;Xx_NEWLINE_xXAny ongoing infection whether receiving or not receiving antibiotics or have received intravenous antibiotics, antiviral, or antifungal agents within 2 weeks prior to the start of the study drug.Xx_NEWLINE_xXActive infection requiring intravenous antibiotics within 7 days before enrollmentXx_NEWLINE_xXInfection requiring parenteral antibiotics, antivirals, or antifungals within 2 weeks prior to C1D1.Xx_NEWLINE_xXSubjects with active infection that requires parenteral antibioticsXx_NEWLINE_xXActive infection requiring parenteral antibioticsXx_NEWLINE_xXPatients must not have an active major systemic infection requiring systemic antibiotics 72 hours or less prior to the first dose of study drugXx_NEWLINE_xXPatients should be free of active infection requiring antibioticsXx_NEWLINE_xXSevere, active comorbidity, defined as follows:\r\n* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\r\n* Active Crohn’s disease or ulcerative colitis\r\n* SclerodermaXx_NEWLINE_xXActive infection requiring intravenous (IV) antibiotic usage within the last week prior to the dosimetry portion of the studyXx_NEWLINE_xXNo active infection: patients should be afebrile; if present, pulmonary infiltrates or other sites of infection must be improving on antibiotics; patients should not require oxygen; study chair will be the arbiter of this criterionXx_NEWLINE_xXActive infection requiring intravenous antibiotics at the time of registrationXx_NEWLINE_xXAcute infection requiring treatment (IV antibiotics, antivirals, or antifungals) within 14 days prior to initiation of studyXx_NEWLINE_xXOral or IV antibiotics within 2 weeks prior to enrollmentXx_NEWLINE_xXAcute infection requiring systemic anti-infectives, antivirals, or antifungals within two weeks prior to first doseXx_NEWLINE_xXPatients with an active infection requiring intravenous antivirals, antibiotics or antifungals; patients on prolonged antifungal therapy are still eligible if they are culture negative and biopsy negative in suspected residual radiographic lesions have stabilized or regressed and they meet other organ function criteriaXx_NEWLINE_xXPatients must be free of systemic infection requiring intravenous (IV) antibiotics at the time of registration; patients must be off IV antibiotics for at least 7 days prior to registrationXx_NEWLINE_xXMust be free of systemic infection; subjects with active infections (whether or not they require antibiotic therapy) may be eligible after complete resolution of the infection; subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatmentXx_NEWLINE_xXHas an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection.Xx_NEWLINE_xXActive infection requiring systemic therapy with IV antibioticsXx_NEWLINE_xXUnstable systemic disease in the opinion of the treating physician, for example active infection requiring intravenous (IV) antibioticsXx_NEWLINE_xXUncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the studyXx_NEWLINE_xXActive infection or chronic infection requiring chronic suppressive antibiotics.Xx_NEWLINE_xXUncontrolled active infection requiring systemic antibiotics, antivirals, or antifungals within one week prior to first dose; prophylactic antimicrobials are permittedXx_NEWLINE_xXActive, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.Xx_NEWLINE_xXActive infection requiring antibioticsXx_NEWLINE_xXActive infection not adequately responding to appropriate antibiotics (i.e. ongoing temperatures of >= 38 degree Celsius)Xx_NEWLINE_xXSerious active infection requiring intravenous (IV) antibioticsXx_NEWLINE_xXActive clinically significant infection requiring antibioticsXx_NEWLINE_xXMust not have acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrollment.Xx_NEWLINE_xXAcute active infection requiring intravenous antibiotics, antiviral (except antiviral directed at hepatitis B), or antifungal agents within 14 days of first doseXx_NEWLINE_xXPatients must be free of systemic infection requiring intravenous (IV) antibiotics at the time of registration; patients must be off IV antibiotics for at least 7 days prior to registrationXx_NEWLINE_xXAcute infection requiring systemic antibiotics, antivirals, or antifungals within 14 days prior to first doseXx_NEWLINE_xXPatients should be free of active infection requiring intravenous antibioticsXx_NEWLINE_xXActive serious infection not controlled by oral or intravenous antibioticsXx_NEWLINE_xXActive infection requiring antibioticsXx_NEWLINE_xXPatients with ongoing use of prophylactic antibiotics are eligible as long as there is no evidence of active infection and the antibiotic is not included on the list of prohibited medicationsXx_NEWLINE_xXPatients with an active infection that require systemic antibiotics, antiviral, or antifungal treatmentsXx_NEWLINE_xXPatients must be free of systemic infection requiring intravenous (IV) antibiotics at the time of registration; patients must be off IV antibiotics for at least 7 days prior to registrationXx_NEWLINE_xXActive infection requiring treatment with systemic antibiotics or systemic anti-fungal agentsXx_NEWLINE_xXActive infection requiring parenteral antibioticsXx_NEWLINE_xXActive infection requiring oral or intravenous antibioticsXx_NEWLINE_xXActive uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia that require IV antibiotics within 2 weeks of starting study treatmentXx_NEWLINE_xXActive infection or chronic infection requiring chronic suppressive antibiotics.Xx_NEWLINE_xXTreated with antibiotics for infection within one week prior to study entry.Xx_NEWLINE_xXUncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within 14 days prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the studyXx_NEWLINE_xXPatients with any serious active infection (i.e., requiring an intravenous antibiotic, antifungal, or antiviral agent)Xx_NEWLINE_xXActive, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.Xx_NEWLINE_xXPatients who have an acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to registration are NOT eligible for participationXx_NEWLINE_xXInfection requiring intravenous antibiotic use within 1 week.Xx_NEWLINE_xXPatients with active chronic or current infections requiring oral or intravenous antibiotics are NOT eligible for enrollment to the study until resolution of the infection and completion of therapeutic antibioticsXx_NEWLINE_xXSerious active infection not controlled by antibioticsXx_NEWLINE_xXActive infection requiring antibiotic, antiviral, or antifungal treatment.Xx_NEWLINE_xXPatients who have received oral or IV antibiotics within 2 weeks before initiation of study treatment; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXActive clinically serious infection requiring intravenous antibiotics at the time of study entry (CTCAE Grade 2)Xx_NEWLINE_xXORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Signs or symptoms of systemic systemic infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infectionXx_NEWLINE_xXHPV-ASSOCIATED OROPHARYNX SQUAMOUS CELL CARCINOMA: Signs or symptoms of systemic bacterial infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infection)Xx_NEWLINE_xXIf they have a major systemic infection requiring antibiotics 72 hours or less prior to the first dose of study drugXx_NEWLINE_xXHas an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals.Xx_NEWLINE_xXMajor active infection requiring parenteral antibiotics.Xx_NEWLINE_xXActive infection requiring IV antibiotic usage within the last week prior to study treatmentXx_NEWLINE_xXInfection requiring intravenous antibiotic use within 1 week.Xx_NEWLINE_xXActive infection requiring parenteral antibioticsXx_NEWLINE_xXReceived oral or IV antibiotics within 2 weeks prior to cycle 1, day 1 (Patients receiving prophylactic antibiotics [e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease] are eligible.)Xx_NEWLINE_xXActive infection requiring intravenous (IV) antibiotics or other uncontrolled intercurrent illness requiring hospitalization.Xx_NEWLINE_xXActive infection requiring intravenous (IV) antibiotics or other uncontrolled intercurrent illness requiring hospitalizationXx_NEWLINE_xXTreatment with antibiotics within 2 weeks (14 days) of dosingXx_NEWLINE_xXReceived oral or IV antibiotics within 2 weeks prior to week 1, day 1\r\n* Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXActive infection requiring parenteral antibiotics.Xx_NEWLINE_xXAcute infection requiring intravenous antibiotics, antiviral or antifungal agents during the 14 days prior to first dose of rucaparibXx_NEWLINE_xXSubjects with an active infection requiring antibiotics or at an increased risk of latent infection that may affect safe study participationXx_NEWLINE_xXReceived oral or IV antibiotics within 2 weeks prior to cycle 1, day 1\r\n* Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXRefractory congestive heart failure unresponsive to medical treatment, active infection resistant to all antibiotics, or advanced non-MDS associated pulmonary disease requiring >2 liters per minute oxygen.Xx_NEWLINE_xXSerious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior.Xx_NEWLINE_xXSerious infection requiring hospitalization or intravenous (IV) antibiotics within 14 days prior to enrollmentXx_NEWLINE_xXSubjects with active infection requiring IV antibiotics within 2 weeks of study enrollment (day 1) are excludedXx_NEWLINE_xXReceived oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXSubject has an uncontrolled active infection requiring treatment and fever 38.3°C or higher 48 hours before the first dose of study drug. Controlled infections (i.e. 3 negative cultures completing antibiotics and/or stable fungal infection in therapy are allowed provided the subject has a temperature of <38.3°C within 48 hours of the first dose of study drugXx_NEWLINE_xXUncontrolled active infection; patients with infection requiring parenteral antibiotics are eligible if the infection is controlledXx_NEWLINE_xXActive infection-must be afebrile and off antibioticsXx_NEWLINE_xXParticipants with an active infection requiring antibiotics are excluded (a positive screening urinalysis may be repeated)Xx_NEWLINE_xXPatients must not have an active infection requiring current treatment with parenteral antibioticsXx_NEWLINE_xXActive, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungalsXx_NEWLINE_xXUncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptableXx_NEWLINE_xXReceived oral or IV antibiotics within 2 weeks prior to cycle 1, day 1\r\n* Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXUncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the studyXx_NEWLINE_xXActive infection requiring antibiotics or antifungals within 7 days prior to first dose of study drugXx_NEWLINE_xXPatients with post-obstructive pneumonia are eligible provided they no longer require intravenous antibiotics at registrationXx_NEWLINE_xXUncontrolled infection requiring active treatment (systemic antibiotics, anti-virals, or anti-fungals) within 14 daysXx_NEWLINE_xXAny active infection not controlled by antibioticsXx_NEWLINE_xXInfection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment unless the patient is felt to have fully recovered and any antibiotics that are continued are either beta lactam antibiotics or are specifically allowed on studyXx_NEWLINE_xXActive infection or chronic infection requiring chronic suppressive antibioticsXx_NEWLINE_xXPatients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])Xx_NEWLINE_xXActive infection requiring intravenous antibioticsXx_NEWLINE_xXSerious, active infections requiring treatment with IV antibioticsXx_NEWLINE_xXAt least 7 days beyond any infection requiring intravenous antibiotic use (Oral\n             antibiotics may be administered prophylactically as clinically indicated)Xx_NEWLINE_xXPatients have an active infection and require intravenous (IV) or oral antibioticsXx_NEWLINE_xXPatients with acute hepatitis or active infection that requires parenteral antibioticsXx_NEWLINE_xXPatients with any unstable medical issue (including cardiac issues as above, active treatment for pulmonary embolism, cerebrovascular accident [CVA], renal or hepatic insufficiency, active infection/sepsis requiring IV antibiotics)Xx_NEWLINE_xXReceived therapeutic oral or IV antibiotics within 2 weeks prior to first dosing.Xx_NEWLINE_xXReceipt of intravenous antibiotics for infection within 7 days prior to enrollmentXx_NEWLINE_xXEvidence of any active infection requiring hospitalization or IV antibiotics within 2 weeks prior to study enrolment.Xx_NEWLINE_xXPatients should be free of active infection requiring antibiotics (with the exception of an uncomplicated urinary tract infection [UTI])Xx_NEWLINE_xXActive infection, or chronic infection requiring chronic suppressive antibiotics.Xx_NEWLINE_xXPatients should be free of active infection requiring parenteral antibiotics.Xx_NEWLINE_xXPatients with active infection requiring parenteral antibiotics.Xx_NEWLINE_xXKnown active infection requiring parenteral or oral anti-infective treatmentXx_NEWLINE_xXActive pulmonary infection not responsive to conventional antibioticsXx_NEWLINE_xXTreatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment; patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the studyXx_NEWLINE_xXReceived therapeutic oral or IV antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXSigns or symptoms of serious active infection requiring oral or i.v. antibiotics within 2 weeks prior to cycle 1 day 1 and/or hospitalization at study entry including, but not limited to, hospitalization for complications of infection, bacteremia, active tuberculosis or severe pneumoniaXx_NEWLINE_xXPatients with active infection and requiring intravenous (IV) or oral antibioticsXx_NEWLINE_xXSigns or symptoms of systemic bacterial infection (use of antibiotics to treat superficial infection or contamination of tumor shall not, by itself, be considered evidence of infection).Xx_NEWLINE_xXSerious active infection requiring intravenous (i.v.) antibiotics at enrollmentXx_NEWLINE_xXSigns/symptoms of infection, or use of antibiotics within 2 weeks of study drugXx_NEWLINE_xXOngoing infection that requires parenteral treatment with antibioticsXx_NEWLINE_xXAny known HIV infection or AIDS or any concurrent infection requiring IV antibioticsXx_NEWLINE_xXActive systemic infections requiring intravenous antibioticsXx_NEWLINE_xXCurrently requiring any type of full-dose anti-coagulation treatment, systemic administration of antibiotics or chronic administration of anti-viral agentsXx_NEWLINE_xXPatients must not have uncontrolled active systemic infection requiring intravenous antibioticsXx_NEWLINE_xXPatients with active systemic infection requiring intravenous antibioticsXx_NEWLINE_xXParticipant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapyXx_NEWLINE_xXAcute bacterial or fungal infection requiring intravenous antibiotics at the time of registration or within 2 weeks of cycle 1 day 1.Xx_NEWLINE_xXTherapeutic oral or IV antibiotics within 2 weeks prior to cycle 1, day 1\r\n* Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or to prevent chronic obstructive pulmonary disease exacerbation) are eligibleXx_NEWLINE_xXActive infection requiring parenteral antibiotics, antivirals, or antifungals within 2 weeks prior to first dose of study drugXx_NEWLINE_xXHave active serious infection uncontrolled by antibiotics or antifungalsXx_NEWLINE_xXReceived oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXSerious active infection requiring intravenous antibiotics and/or hospitalization at study entryXx_NEWLINE_xXCurrent infection requiring parenteral antibioticsXx_NEWLINE_xXPatients with active infection requiring systemic antibiotics, antiviral, or antifungal treatmentsXx_NEWLINE_xXOngoing or active infection; treatment with systemic antibiotics or antifungals for ongoing or recurrent infection (topical use of antibiotics or antifungals is allowed)Xx_NEWLINE_xXHas an active infection requiring systemic antibiotics within 7 days of registrationXx_NEWLINE_xXActive infection or antibiotics within 48 hours prior to studyXx_NEWLINE_xXUncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptableXx_NEWLINE_xXPatients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.Xx_NEWLINE_xXClinically relevant active infection requiring treatment (antibiotics, antivirals, antifungals)Xx_NEWLINE_xXAcute infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to initiation of studyXx_NEWLINE_xXUncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptableXx_NEWLINE_xXActive infection within the 14 days prior to randomization requiring systemic antibioticsXx_NEWLINE_xXAny infection requiring ongoing intravenous antibiotics for managementXx_NEWLINE_xXPatient has evidence of a serious active infection (e.g., infection requiring treatment with intravenous antibiotics).Xx_NEWLINE_xXActive infection requiring intravenous (IV) antibiotics or other uncontrolled intercurrent illness requiring hospitalizationXx_NEWLINE_xXActive infection requiring antibiotics or antifungals within 7 days prior to first dose of study drugXx_NEWLINE_xXUncontrolled active infection requiring parenteral antibiotics, antivirals or antifungals within 1 week prior to the first date of study treatmentXx_NEWLINE_xXAcute infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to initiation of studyXx_NEWLINE_xXUncontrolled infections not responsive to antibiotics, antiviral medicines, or antifungal medicines or a recent infection requiring systemic treatment that was completed ?14 days before the first dose of study drug.Xx_NEWLINE_xXUncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the studyXx_NEWLINE_xXInfection requiring intravenous (IV) antibiotic therapy or other serious infection within 14 days before randomization.Xx_NEWLINE_xXUncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first doseXx_NEWLINE_xXPresence of active infection within 72 hours of treatment; patients with ongoing use of prophylactic antibiotics are eligible as long as there is no evidence of active infection and the antibiotic is not included on the list of prohibited medicationsXx_NEWLINE_xXChronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis CXx_NEWLINE_xXSubjects with active infection that requires parenteral antibioticsXx_NEWLINE_xXSerious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.Xx_NEWLINE_xXAcute active infection requiring treatment (IV antibiotics, antivirals, or antifungals) within 14 days prior to the first day of treatmentXx_NEWLINE_xXUncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1Xx_NEWLINE_xXHave an ongoing or active infection. The requirement for intravenous (IV) antibiotics is considered active infection.Xx_NEWLINE_xXUncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first doseXx_NEWLINE_xXPresence of an acute infection requiring active treatment with antibiotics/antivirals; prophylactic administration is allowedXx_NEWLINE_xXSerious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior to the first dose of study treatment.Xx_NEWLINE_xXNo acute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to cycle 1 day 1Xx_NEWLINE_xXReceipt of intravenous (IV) antibiotics for infection within 7 days prior to enrollment into the studyXx_NEWLINE_xXActive infection requiring treatment with IV antibiotics or hospitalized for treatment of an active infection in 4 wks prior to starting dose of AMG 592.Xx_NEWLINE_xXKnown active infection requiring parenteral or oral anti-infective treatmentXx_NEWLINE_xXPatients with active infection and requiring intravenous (IV) or oral antibioticsXx_NEWLINE_xXAcute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to signing consentXx_NEWLINE_xXPatients with infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study; patients on prophylactic antibiotics or antivirals are acceptable.Xx_NEWLINE_xXSerious/active infection or infection requiring parenteral antibioticsXx_NEWLINE_xXActive infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to first doseXx_NEWLINE_xXInfection requiring intravenous antibiotics within 14 days before the first dose of study drugXx_NEWLINE_xXNo significant intercurrent illness such as an active infection associated with fever lasting more than 24 hours requiring antibiotics, uncontrolled psychiatric illness, hypercalcemia (calcium greater than 11 mg), or active gastrointestinal (GI) bleedingXx_NEWLINE_xXActive infection requiring IV antibiotics, antifungal or antiviral agents, that in the opinion of the investigator would compromise the patient’s ability to tolerate therapyXx_NEWLINE_xXAny uncontrolled systemic inflammatory disease or infection requiring antibiotics, non-steroidal, or steroidal anti-inflammatory agents on a daily basisXx_NEWLINE_xXAcute active infection requiring systemic antibiotics, antivirals, or antifungals within two weeks prior to first doseXx_NEWLINE_xXConcurrent severe and/or uncontrolled medical disease including, but not limited to, ongoing or active infection requiring intravenous antibiotics, bowel obstructionXx_NEWLINE_xXConcurrent severe and/or uncontrolled medical disease including, but not limited to, ongoing or active infection requiring intravenous antibioticsXx_NEWLINE_xXPresence of acute active infection requiring antibioticsXx_NEWLINE_xXChronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis CXx_NEWLINE_xXMust be free of systemic infection; subjects with active infections (whether or not they require antibiotic therapy) may be eligible after complete resolution of the infection; subjects on antibiotic therapy must be off antibiotics for at least 7 days before beginning treatmentXx_NEWLINE_xXActive infection (including HIV/acquired immune deficiency syndrome [AIDS], hepatitis B, or hepatitis C infection) requiring systemic antibiotics, antivirals, or antifungalsXx_NEWLINE_xXSerious active infection requiring i.v. antibiotics and/or hospitalization at study entryXx_NEWLINE_xXPatients with unstable or serious concurrent illness including, but not limited to, ongoing or active infections requiring IV antibiotics or psychiatric illness/social situations that would limit compliance with study requirements are ineligible; (if patient has a stable chronic infection requiring oral antibiotics, the patient may be treated at the investigators discretion; however a clinical note must include the justification regarding the safety of treating the patient)Xx_NEWLINE_xXChronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis CXx_NEWLINE_xXUncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous antibioticsXx_NEWLINE_xXPatients with acute hepatitis or active infection that requires parenteral antibiotics are excludedXx_NEWLINE_xXPatients with an active infection requiring antibioticsXx_NEWLINE_xXChronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment as such, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis CXx_NEWLINE_xXSerious, active infections requiring treatment with intravenous (IV) antibioticsXx_NEWLINE_xXActive infection not adequately responding to appropriate antibiotics (i.e. ongoing temperatures of >= 38 degree Celsius)Xx_NEWLINE_xXUncontrolled inter-current illness including, but not limited to ongoing or active infection requiring intravenous antibiotics, ongoing immunosuppressive therapy (except for replacement steroids), active human immunodeficiency virus (HIV) infection, that might jeopardize the ability of the patient to receive the chemotherapy program outlined in this protocol with reasonable safetyXx_NEWLINE_xXPatients should be free of active infection requiring antibioticsXx_NEWLINE_xXUncontrolled infection requiring ongoing antibioticsXx_NEWLINE_xXActive infection, uncontrolled with intravenous antibioticsXx_NEWLINE_xXUncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibiotics on day 1Xx_NEWLINE_xXReceived oral or intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXPatients with active infection requiring intravenous (IV) antibiotics within 2 weeks of registrationXx_NEWLINE_xXReceived oral or IV antibiotics within 2 weeks prior to cycle 1, day 1 for treatment of active infection (patients receiving prophylactic antibiotics [e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease] are eligible)Xx_NEWLINE_xXPatients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXPatients with acute hepatitis or active infection that requires parenteral antibiotics.Xx_NEWLINE_xXChronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatmentXx_NEWLINE_xXActive systemic infections requiring intravenous antibioticsXx_NEWLINE_xXPatients must not have a serious intercurrent illness including, but not limited to, ongoing or active infection requiring parenteral antibioticsXx_NEWLINE_xXActive serious infection not controlled by oral or intravenous antibioticsXx_NEWLINE_xXPatients with active infection will not be eligible, but may become eligible once infection has resolved and they are at least 7 days from completion of antibioticsXx_NEWLINE_xXCurrent severe, uncontrolled systemic disease including an ongoing, active infection requiring treatment with antibioticsXx_NEWLINE_xXUncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first doseXx_NEWLINE_xXPatients with an active infection that requires systemic antibiotics, antiviral, or antifungal treatmentsXx_NEWLINE_xXActive infection involving IV antibiotics within 2 weeks prior to C1D1Xx_NEWLINE_xXActive infection involving IV antibiotics within 2 weeks prior to C1D1Xx_NEWLINE_xXConcurrent serious infection requiring parenteral antibiotic therapy.Xx_NEWLINE_xXActive clinically significant infection requiring antibioticsXx_NEWLINE_xXChronic or current infectious disease requiring systemic antibiotics, antifungal (excluding antifungals given for nail-beds infections), or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis CXx_NEWLINE_xXPatients have an active infection and require intravenous (IV) or oral antibioticsXx_NEWLINE_xXUncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the studyXx_NEWLINE_xXUncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.Xx_NEWLINE_xXAcute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to enrollmentXx_NEWLINE_xXPatients should not have any evidence of active or uncontrolled infection requiring treatment with antibioticsXx_NEWLINE_xXKnown active infection requiring parenteral or oral anti-infective treatment.Xx_NEWLINE_xXHas an active infection requiring antibioticsXx_NEWLINE_xXOngoing or active infection requiring parental antibiotics on Day 1Xx_NEWLINE_xXThey should have no significant intercurrent illness such as an active infection associated with fever lasting more than 24 hours requiring antibiotics, uncontrolled psychiatric illness, hypercalcemia (calcium greater than 11 mg), or active gastrointestinal (GI) bleedingXx_NEWLINE_xXKnown active infection requiring antibiotics within 7 days of the start of treatment (day 0)Xx_NEWLINE_xXReceived IV antibiotics within 2 weeks prior to cycle 1, day 1; patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are eligibleXx_NEWLINE_xXPatients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])Xx_NEWLINE_xXNo active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection)Xx_NEWLINE_xXOngoing or active infection requiring parenteral antibiotics.Xx_NEWLINE_xXOngoing or active infection requiring IV antibioticsXx_NEWLINE_xXActive infection requiring antibioticsXx_NEWLINE_xXTreatment with antibiotics within 2 weeks (14 days) of dosing.Xx_NEWLINE_xXDoes not have an uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptableXx_NEWLINE_xXAny active infection requiring the use of parenteral anti-microbial agents or that is > Grade 2;Xx_NEWLINE_xXActive infection requiring intravenous antibioticsXx_NEWLINE_xXHas an active infection requiring systemic antibiotics.Xx_NEWLINE_xXActive infection requiring antibioticsXx_NEWLINE_xXActive infection requiring intravenous (IV) antibioticsXx_NEWLINE_xXPatient with an infection requiring treatment with systemic antibiotics or antiviral medication or has completed treatment for such an infection within 4 days prior to planned initial dose of WT2725.Xx_NEWLINE_xXSerious infection requiring intravenous antibiotic therapy within 14 days prior to study treatmentXx_NEWLINE_xXAny uncontrolled active systemic infection that requires treatment with intravenous (IV) antibioticsXx_NEWLINE_xXPresence of an infection that requires intravenous antibioticsXx_NEWLINE_xXOngoing or active infection requiring antibiotics;Xx_NEWLINE_xXUncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the studyXx_NEWLINE_xXUncontrolled active infection; patients with infection requiring parenteral antibiotics are eligible if the infection is controlledXx_NEWLINE_xXHas an active infection requiring systemic antibioticsXx_NEWLINE_xXChronic or current active infections requiring systemic antibiotics, antifungals or antiviral therapyXx_NEWLINE_xXActive infection requiring IV antibioticsXx_NEWLINE_xXSerious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.Xx_NEWLINE_xXActive infection requiring intravenous antibiotics.Xx_NEWLINE_xXHas an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection.Xx_NEWLINE_xXInfection not controlled by antibioticsXx_NEWLINE_xXActive infection requiring antibioticsXx_NEWLINE_xXActive, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals. The Medical Monitor should be contacted for any uncertainties.Xx_NEWLINE_xXActive, clinically significant serious infection requiring treatment with antibiotics, anti-virals, or anti-fungals.Xx_NEWLINE_xXSerious/active infection or infection requiring parenteral antibioticsXx_NEWLINE_xXActive infection requiring parenteral antibioticsXx_NEWLINE_xXCurrent acute infection requiring intravenous antibioticsXx_NEWLINE_xXActive infection requiring antibioticsXx_NEWLINE_xXSerious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment.Xx_NEWLINE_xXUncontrolled medical illness such as infection requiring intravenous antibioticsXx_NEWLINE_xXAcute active infection requiring systemic antibiotics, antiviral (except antiviral directed at hepatitis B) or antifungal agents within 14 days of first doseXx_NEWLINE_xXThe patient has ongoing or active infection requiring parenteral antibiotics.Xx_NEWLINE_xXActive infection requiring antibioticsXx_NEWLINE_xXPatients with any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever > 38ºC within 1 week prior to first study drug administration.Xx_NEWLINE_xXSerious infection requiring parenteral antibiotics within 14 days of enrollmentXx_NEWLINE_xXAcute active infection requiring systemic antibiotics, antivirals, or antifungals within 14 days prior to first doseXx_NEWLINE_xXAcute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomizationXx_NEWLINE_xXActive infection requiring IV antibiotics within 2 weeks prior to screeningXx_NEWLINE_xXPatients with any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever > 38ºC within 2 weeks prior to first study drug administration.Xx_NEWLINE_xXActive infection requiring intravenous (IV) antibioticsXx_NEWLINE_xXActive infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening.Xx_NEWLINE_xXSerious infection requiring treatment with systemically administered antibiotics at the time of study entrance, or an infection requiring systemic antibiotic therapy within 7 days prior to the first dose of study treatment. For the HCC, HCC/BTC and BTC subgroups hepatitis C infection and hepatitis B infection if controlled with antiviral therapy are allowable.Xx_NEWLINE_xXAcute active infection requiring systemic antibiotics, antivirals, or antifungals within 14 days prior to first doseXx_NEWLINE_xXKnown active infection requiring intravenous (IV) or oral anti-infective treatmentXx_NEWLINE_xXChronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis CXx_NEWLINE_xXActive infection requiring systemic anti-microbial treatment (including antibiotics, anti-fungals, and anti-viral agents)Xx_NEWLINE_xXActive infection requiring iv antibioticsXx_NEWLINE_xXAcute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to randomization.Xx_NEWLINE_xXTreatment with antibiotics for proven infection within 1 week prior to study entry or signs and symptoms consistent with an active infection or fever > 38.1 C.Xx_NEWLINE_xXPresence of an acute infection requiring antibiotics within 4 weeks of study entry or a chronic infection including but not limited to: urinary tract infection, HIV, viral hepatitisXx_NEWLINE_xXUncontrolled infection requiring systematic antibiotics within 14 days before the first dose of study drugXx_NEWLINE_xXSerious/active infection or infection requiring parenteral antibioticsXx_NEWLINE_xXHas uncontrolled infection requiring systematic antibioticsXx_NEWLINE_xXPatients with active infection requiring systemic antibiotics, antiviral, or antifungal treatmentsXx_NEWLINE_xXHistory of any infection requiring hospitalization or intravenous antibiotics within 2 weeks before enrollment.Xx_NEWLINE_xXActive infection requiring (IV) antibiotics within 2 weeks of study enrollmentXx_NEWLINE_xXHas an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapyXx_NEWLINE_xXThe participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy.Xx_NEWLINE_xXActive infection requiring IV antibioticsXx_NEWLINE_xXChronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, active Hepatitis C, and known HIV disease. All HIV-positive patients are excluded from this study, regardless of whether they have an Acquired Immunodeficiency Syndrome (AIDS) defining disease and/or are on antiviral therapy. Prophylactic antiviral and/or antibacterial antibiotics to prevent recurrence of previous infections are permitted.Xx_NEWLINE_xXAcute active infection requiring treatment (systemic antibiotics, antivirals, or antifungals) within 14 days prior to randomizationXx_NEWLINE_xXActive infection requiring parenteral antibiotics within one-week prior to studyXx_NEWLINE_xXThe patient has received intravenous administration of antibiotics within 2 weeks prior to first study treatment or oral antibiotics within 1 week prior to first study treatment.Xx_NEWLINE_xXActive HSV infection requiring treatment, or requiring intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g. acyclovir)Xx_NEWLINE_xXActive infection requiring parenteral antibioticsXx_NEWLINE_xXActive systemic infections requiring intravenous antibioticsXx_NEWLINE_xXReceived therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to first day of study treatment; patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligibleXx_NEWLINE_xXUncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the studyXx_NEWLINE_xXAny infection requiring antibiotics within the past 2 weeks.Xx_NEWLINE_xXHave an active, clinically significant serious infection requiring intravenous treatment with antibiotics, antivirals, or antifungals.Xx_NEWLINE_xXUncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptableXx_NEWLINE_xXSerious infection requiring antibioticsXx_NEWLINE_xXPatients taking antibiotics or who plan to begin taking antibioticsXx_NEWLINE_xXUse of intravenous antibiotics within the last 6 monthsXx_NEWLINE_xXPneumonia requiring antibiotics at the time of study enrollmentXx_NEWLINE_xXPatient is currently on antibioticsXx_NEWLINE_xXPatients with a previous or current line infection are ineligible until 14 days after the completion of antibioticsXx_NEWLINE_xXUse of antibiotics =< 3 days prior to registrationXx_NEWLINE_xXPatients with ongoing use of prophylactic antibiotics are eligible as long as there is no evidence of active infection and the antibiotic is not included on the list of prohibited medicationsXx_NEWLINE_xXHave had an infection requiring the use of parenteral antibiotics within 14 days prior to the start of Day 1;Xx_NEWLINE_xXUncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to the first dose; active infection with concurrent treatment is acceptable only if the patient is clinically stableXx_NEWLINE_xXSerious concomitant medical condition that could interfere with the conduct of the clinical trial, such as unstable angina, renal failure requiring hemodialysis, or active infection requiring intravenous (IV) antibioticsXx_NEWLINE_xXInfection not controlled by antibioticsXx_NEWLINE_xXAny infection requiring parenteral antibiotics within the past 2 weeksXx_NEWLINE_xXDiagnosis of an infection requiring intravenous (IV) antibiotics 14 days prior to registrationXx_NEWLINE_xXUse of antibiotics =< 3 days prior to registrationXx_NEWLINE_xXActive infection requiring antibioticsXx_NEWLINE_xXUse of antibiotics within the past 7 daysXx_NEWLINE_xXActive systemic infection requiring ongoing intervention, including but not limited to oral and intravenous antibiotics, anti-fungals, anti-parasites, anti-viralsXx_NEWLINE_xXChronic use of systemic antibiotics; topical lotions which include antibiotics are permitted; occasional use of antibiotics is allowed, but must be stopped for 3 weeks prior to RPFNA and for 3 weeks prior to collecting blood or urine specimens for the pre-study (i.e., prior to dispensing/starting study agent) assessment of lignan levelsXx_NEWLINE_xXNo use of antibiotics in the previous 3 months; or current regular use of antibioticsXx_NEWLINE_xXSubject has known or suspected HIV or other active infections requiring acute or chronic treatment with systemic antibiotics. Conditions requiring topical antibiotics are acceptable.Xx_NEWLINE_xXHave a chronic or active infection that requires systemic antibiotics, antifungal or antiviral treatmentXx_NEWLINE_xXNo active infection within 14 days of study enrollment requiring parenteral antibioticsXx_NEWLINE_xXPatients should be free of active infection requiring antibioticsXx_NEWLINE_xXA non?urologic bacterial infection requiring active treatment with antibioticsXx_NEWLINE_xXUse of antibiotics one (1) month prior to or during this studyXx_NEWLINE_xXHistory of taken antibiotics in the previous 3 monthsXx_NEWLINE_xXUncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to C1D1.Xx_NEWLINE_xXHas an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or tested positive for active hepatitis B or C infectionXx_NEWLINE_xXPatients with ongoing use of prophylactic antibiotics are eligible as long as there is no evidence of active infection and the antibiotic is not a prohibited medicationXx_NEWLINE_xXKnown active infection requiring parenteral or oral anti-infective treatment within defined periodXx_NEWLINE_xXPatients with active and/or uncontrolled infections or who are still recovering from an infection\r\n* Actively febrile patients with uncertain etiology of febrile episode\r\n* All antibiotics should be completed at least 1 week (7 days) prior to collection\r\n* No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics\r\n* Note: Use of antibiotics for pre-operative prophylaxis is not an exclusionXx_NEWLINE_xXHave taken antibiotics =< 7 days prior to registrationXx_NEWLINE_xXActive infection requiring oral or intravenous antibioticsXx_NEWLINE_xXReceived oral or IV antibiotics within 14 days prior to Day 1Xx_NEWLINE_xXThe participant has an active infection (requiring intravenous [IV] antibiotics), including tuberculosis.Xx_NEWLINE_xXThe participant has an active infection (requiring I.V antibiotics), including tuberculosis.Xx_NEWLINE_xXKnown active infection requiring antibiotics within 7 days of initiation of study treatment, unless considered controlled in the opinion of the investigatorXx_NEWLINE_xXCurrent infection requiring parenteral antibioticsXx_NEWLINE_xX