Protocol treatment is to begin within 2 calendar days of patient randomization.
The minimum time requirement between date of surgery and randomization must be at least 4 weeks (28 days)
Complete recovery from surgery and standard post-operative therapy (if required); patients must be completely recovered from surgery at the time of randomization; the minimum time requirement between date of surgery and randomization must be at least 28 days, the maximum time requirement between surgery and randomization must be 90 days if no adjuvant chemotherapy was administered, 240 days if adjuvant chemotherapy was administered, and 300 days if adjuvant chemotherapy and radiation therapy was administered
Patients must have adequately recovered from surgery and any administered chemotherapy/radiotherapy at the time of randomization (NOTE: adjuvant chemotherapy and/or radiation is not required)\r\n* Minimum time between date of surgery and randomization is 4 weeks (28 days)\r\n* Maximum time allowed between surgery and randomization:\r\n** 3 months (90 days) if no chemotherapy is administered\r\n** 8 months (240 days) if adjuvant chemotherapy was administered\r\n** 10 months (300 days) if adjuvant chemotherapy and radiation therapy was administered
The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 70 days; also, if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 70 days
Platelet count >= 100 x 10^9/L measured within 28 days prior to randomization
Serum or plasma creatinine =< 1.5 x ULN measured within 28 days prior to randomization
CYP3A isoenzymes within 7 days of randomization.
Radiotherapy within 14 days before randomization; seven days may be considered if to single area
Patients must be able to start treatment within 56 days of randomization.
Randomization within 28 days of diagnosis of last progression
Radiotherapy within 14 days before randomization.
Patients must be able to start treatment within 56 days of randomization.
The most recent dose of olaratumab must have been received within 180 days of randomization in this study.
Treatment with any investigational products or with chimeric or fully human monoclonal antibodies within 30 days before randomization, systemic anticancer therapy or radiotherapy within 14 days before randomization (Note: \spot\ radiation for areas of pain is permitted), and major surgery within 14 days before randomization.
Radiotherapy within 14 days before randomization; seven days may be considered if to single area
Subjects who within 14 days prior to randomization have had major surgery or a lumbar puncture (or epidural steroid injection);
Protocol treatment is to begin within 2 working days of patient randomization
Palliative surgery and/or radiation treatment < 21 days prior to date of randomization.
Exposure to any systemic chemotherapy within 21 days of date of randomization.
Receipt of posaconazole or voriconazole as empirical treatment for this infection for 4 days (96 hours) or more within the 15 days immediately before randomization.
Unexplained temperature > 38.5° C for any 7 consecutive days or chronic diarrhea defined as > 3 stools/day persisting for 15 consecutive days, within the 30 days prior to randomization.
Loco-regional therapy to the liver within 28 days before randomization
Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior use of hydroxyurea or other palliative treatment for leukocytosis is allowed.
The participant received radiotherapy within 14 days prior to randomization.
Radiotherapy within 14 days of randomization
Participant has had radiation therapy within 14 days of randomization
Radiotherapy within 14 days prior to randomization except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to randomization. Subjects must have recovered from radiotherapy toxicities prior to randomization
Thrombocytopenia (sustained for at least 21 days) within 14 days prior to randomization
The interval between completion of standard adjuvant chemotherapy and randomization must be less than or equal to 60 days.
Surgery completed at least 28 days before randomization;
Radiotherapy within 28 days of randomization
Have radiation therapy within 14 days prior to randomization.
Surgically rendered free of disease within 90 days of randomization
Chemotherapy, biologic anti-cancer therapy, or central field radiation therapy =< 28 days prior to randomization; Note: local or stereotactic radiation =< 14 days prior to randomization
The participant is receiving chronic therapy with any of the following within 7 days prior to randomization:
The participant received radiotherapy within 14 days prior to randomization.
Immunotherapy within the 21 days prior to randomization
Focal therapy within the 7 days prior to randomization
Extended field therapy within the 21 days prior to randomization
Subject has received any chemotherapy within 21 days prior to randomization.
Participant has had radiation therapy within 14 days of randomization
Participant has had plasmapheresis within 28 days of randomization
Radiotherapy within 14 days before randomization.
Radiotherapy to any site for any reason =< 14 days prior to randomization
Hematopoietic Status (within 30 days prior to randomization):
Hepatic Status (within 30 days prior to randomization):
E 02. Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. Participants on biphosphonates prior to study entry.
Diagnostic of cholangiocarcinoma made more than 45 days prior to randomization
Radiotherapy to any site for any reason within 28 days prior to randomization, except for palliative radiotherapy to bone lesions within 14 days prior to randomization
Prior palliative or curative radiotherapy must be completed at least 14 days prior to randomization
An interval shorter than 21 days from the last dose of chemotherapy or HER2-directed\n             therapy until the time of randomization
Less than 28 days elapsed from prior treatment with immunotherapy, radiotherapy, or surgery to the time of randomization.
Protocol treatment is to begin within 2 working days of patient randomization.
Less than 28 days elapsed from prior radiotherapy, from prior surgery and prior chemotherapy to the time of randomization; less than 42 days elapsed from prior major surgery to the time of randomization
Palliative surgery and/or radiation treatment within 30 days prior to date of randomization.
Exposure to any systemic chemotherapy within 30 days of date of randomization.
Immunotherapy within 21 days prior to randomization
Immunotherapy within 21 days prior to randomization.
Participants with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation (whole brain radiation therapy, focal radiation therapy, and stereotactic radiosurgery) ending at least 14 days prior to randomization, or after surgical resection performed at least 28 days prior to randomization. The participant may have no evidence of Grade 1 (or greater) Central Nervous System (CNS) hemorrhage based on pretreatment scans(performed within 21 days before randomization).
Radiotherapy to multiple sites or immunotherapy/antibody therapy within 28 days prior to randomization; localized radiotherapy to a single site within 7 days prior to randomization
Surgery within 28 days prior to randomization
Surgery must be scheduled no sooner than 10 days after randomization and no more than twelve weeks after randomization
ESA therapy within the 28 days prior to randomization.
Receipt of ART for at least 180 days prior to randomization
Has severe hepatic insufficiency within 5 days before randomization
Platelets >= 100 X 10^9/L (evaluated within 28 days of randomization)
The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 180 days if chemotherapy is not delivered adjuvantly; if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 180 days