Biologic response modifiers (eg, granulocyte colony-stimulating factor) within  weeks before study entry. Chronic erythropoietin therapy is permitted provided that no dose adjustments were made within  months before first dose of study treatment
Patients may not have received chemotherapy, targeted therapies, biologic response modifiers and/or hormonal therapy within the last  days
Prior systemic treatments for metastatic disease are permitted but may not be ongoing, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy
May not have received cytotoxic chemotherapy, targeted therapies, biologic response modifiers, chemotherapy, and hormonal therapy within the last  weeks, or nitrosureas within the last  weeks prior to study treatment.
Use of biologic response modifiers, such as granulocyte colony-stimulating factor (G-CSF), will not be permitted within  weeks prior to study entry; G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity, such as febrile neutropenia, when clinically indicated or at the discretion of the investigator; however, they may not be administered to prevent a dose reduction; patients taking chronic erythropoietin are permitted, provided no dose adjustment is undertaken within  month prior to randomization or during the study
Use of biologic response modifiers within  days of first dosing
A history of prior radiotherapy, chemotherapy, including infusion or perfusion therapy for current disease or any immunotherapy including tumor vaccines, interferon-alfa, interleukins, levamisole or other biologic response modifiers within the past  weeks
Treatment with radiotherapy-response or biological-response modifiers
Have used biologic response modifiers, such as granulocyte-colony stimulating factor, within  weeks prior to signing the ICF.
A history of prior radiotherapy, chemotherapy, including infusion or perfusion therapy for current disease or any immunotherapy including tumor vaccines, interferon-alfa, interleukins, levamisole or other biologic response modifiers within the past  weeks