The subject has or had any active infection requiring systemic antibiotic, antifungal or antiviral therapy within the past 4 weeks
All patients receiving antifungal therapy voriconazole, posaconazole, or fluconazole must have sirolimus reduced according to the Standard Practice Antifungal Therapy Guidelines
Systemic infection requiring treatment with antibiotics, antifungal, or antiviral agents within seven days of registration
Have a chronic or active infection that requires systemic antibiotics, antifungal or antiviral treatment
Currently receiving systemic antibiotic, antiviral, or antifungal therapy for the treatment of an active infection
Recent or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment within 2 weeks prior to the start of study drug
Concomitant 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.
Uncontrolled active infection (bacterial, fungal, viral, mycobacterial) not responding to treatment with intravenous antibiotics, antiviral or antifungal agents
Absence of uncontrolled active infection (bacterial, fungal, viral, mycobacterial) not responding to treatment with antibiotics, antiviral agents, or antifungal agents
Off antibiotic/antifungal therapy for >/=14 days (Cohort C)
Has active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) ? 10 days of C1D1
Active 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 drug
Active infection requiring antibiotics, antifungal or antiviral agents, that in the opinion of the investigator would compromise the patient’s ability to tolerate therapy
Uncontrolled active infection (bacterial, viral, fungal, mycobacterial) not responding to treatment with intravenous antibiotics, antiviral or antifungal agents, or long-term treatment with oral agents
EXCLUSION CRITERIA FOR PATIENTS WITH NSCLC OR TNBC (COHORT B): Uncontrolled active infection (bacterial, viral, fungal, mycobacterial) not responding to treatment with intravenous antibiotics, antiviral or antifungal agents, or long-term treatment with oral agents
EXCLUSION CRITERIA FOR TNBC: Uncontrolled active infection (bacterial, viral, fungal, mycobacterial) not responding to treatment with intravenous antibiotics, antiviral or antifungal agents, or long-term treatment with oral agents
Has active, serious infection requiring systemic therapy. Patients may receive prophylactic antibiotics and antiviral therapy at the discretion of the treating physician.
Patient has or had any active infection requiring antibiotic, antifungal, or antiviral therapy within the 2 weeks prior to administration of Toca 511.
Any 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.
Active (uncontrolled) infection requiring systemic antibiotic therapy with antibacterial, antifungal, or antiviral agents (excluding HIV)
Active, systemic infection requiring intravenous (IV) antibiotic, antifungal, or antiviral therapy or other serious infection within 14 days before the first dose of study drug.
Ongoing bacterial, viral, or antifungal infection requiring antimicrobial treatment with the exception of thrush
Acute active infection requiring intravenous antibiotics, antiviral (except antiviral directed at hepatitis B), or antifungal agents within 14 days of first dose
Receipt of any systemic (oral, intravenous, or inhaled) antifungal therapy for this infection episode for 4 or more consecutive days (>= 96 hours) immediately before randomization.
Developed the current episode of IA infection during receipt of >13 days of antifungal prophylaxis with an agent considered to be a mold-active antifungal agent.
Chronic or current active infection requiring systemic antibiotic, antifungal, or antiviral treatment
Patients with an active infection that require systemic antibiotics, antiviral, or antifungal treatments
Presence of a fungal infection requiring systemic antifungal treatment at enrollment
Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy. Prophylactic antibiotic, antifungal and/or antiviral therapy is permitted
Patients with any serious active infection (i.e., requiring an intravenous antibiotic, antifungal, or antiviral agent)
Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment (defined as requiring IV antimicrobial, antifungal or antiviral agents) ( Subjects on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other inclusion/exclusion criteria are met and there is no evidence of active infection at Screening and/or Cycle 1 Day 1 (predose))
Active infection requiring antibiotic, antiviral, or antifungal treatment.
Per PI discretion, active infection that is not well controlled by antibacterial or antiviral therapy.
Received > 24 hours of systemic antibacterial therapy within 72 hours of the initiation of inpatient IV study drug for treatment of suspected infection; antibiotic prophylaxis is allowed; prophylactic use of antiviral or antifungal medication is permitted
Acute infection requiring intravenous antibiotics, antiviral or antifungal agents during the 14 days prior to first dose of rucaparib
Active infection requiring systemic antibiotic therapy with antibacterial, antifungal, or antiviral agents (excluding HIV)
Treatment with appropriate antiviral therapy for patients with active HBV infection is required
Active infection not well controlled by antibacterial or antiviral therapy.
Currently active and uncontrolled infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment
History of chronic or recurrent infections that require continual use of antiviral, antifungal, or antibacterial agents.
Uncontrolled infection; to be eligible, patients receiving treatment for an infection (antibiotic, antifungal or antiviral treatment) must be afebrile (< 38.3 degrees Celsius [C]) and without hemodynamic instability or dyspnea from pneumonia for > 48 hours (hrs) prior to the start of induction therapy
Participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy
Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments
Uncontrolled 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.
Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment (defined as requiring IV antimicrobial, antifungal or antiviral agents) ? Subjects on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other inclusion/exclusion criteria are met and there is no evidence of active infection at randomization
Active infection requiring IV antibiotics, antifungal or antiviral agents, that in the opinion of the investigator would compromise the patient’s ability to tolerate therapy
Active or uncontrolled infection. Patients with an infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ?72 hrs.
All patients receiving antifungal therapy voriconazole, posaconazole, or fluconazole and who are then randomized to ARM 2 must have sirolimus reduced according to the Standard Practice Antifungal Therapy Guidelines
Invasive fungal or viral infection not responding to appropriate antifungal or antiviral therapies.
Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
Evidence of significant active infection requiring antimicrobial, antifungal, antiparasitic, or antiviral therapy or for which other supportive care is given
Patients with an active infection that requires systemic antibiotics, antiviral, or antifungal treatments
Ongoing systemic bacterial, fungal, or viral infections at randomization (defined as requiring IV antimicrobial, antifungal or antiviral agents)
Subjects on antimicrobial, antifungal or antiviral prophylaxis are not specifically excluded if all other I/E criteria are met
Serious, uncontrolled infection requiring systemic antibiotic, antifungal or antiviral therapy
Active infection requiring systemic antibacterial/antibiotic, antifungal, or antiviral therapy.
Active or uncontrolled infection. Patients with any infection receiving treatment (antibiotic, antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ?72 hrs. Patients with fevers believed to be due to leukemia or MDS are eligible provided a thorough infection work-up is negative and the patient is clinically and hemodynamically stable.
Does the subject have, or has the subject had, within the past 4 weeks any infection requiring antibiotic, antifungal or antiviral therapy?
Acute active infection requiring systemic antibiotics, antiviral (except antiviral directed at hepatitis B) or antifungal agents within 14 days of first dose
Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening.
Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to randomization.
Active systemic viral, bacterial, or fungal infection requiring antimicrobial, antiviral therapy or antifungal therapy within 2 weeks prior to the first dose of study drug (routine antimicrobial prophylaxis is acceptable)
Patients with active infection requiring systemic antibiotics, antiviral, or antifungal treatments
Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy
The participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy.
Known active infections requiring IV antibiotic, antiviral, or antifungal therapy.
Active or uncontrolled infection. Patients with any infection receiving treatment (antibiotic,antifungal or antiviral treatment) may be entered into the study but must be afebrile and hemodynamically stable for ?72 hrs. Patients with fevers believed to be due to leukemia or MDS are eligible provided a thorough infection work-up is negative and the patient is clinically and hemodynamically stable.
Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
Use of systemic antibacterial, antifungal, or antiviral medications for the treatment of acute clinically significant infection within 2 weeks of first veledimex dose. Concomitant therapy for chronic infections is not allowed. Subjects must be afebrile prior to Ad-RTS-hIL-12 injection; only prophylactic antibiotic use is allowed perioperatively
Have a chronic or active infection that requires systemic antibiotics, antifungal or antiviral treatment
Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment, except concomitant antiviral systemic therapy for chronic hepatitis B or C.
Active uncontrolled infection [i.e., antibiotic, antifungal or antiviral intervention indicated or surgical procedure (i.e., pleural or deep abscess drainage) conducted within 15 days prior to inclusion].