Patients must NOT have previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:\r\n* Non-melanoma skin cancer, in situ cervical cancer, superficial bladder cancer, or breast cancer in situ OR\r\n* Prior malignancy completely excised or removed and patient has been continuously disease free for >  years OR\r\n* Prior malignancy cured by non-surgical modalities and patient has been continuously disease free for >  years
Other types of invasive malignancy that are not disease free within  years except for non-melanoma skin cancer, lentigo maligna, any carcinoma-in-situ or prostate cancer with low risk factors
Patients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for >=  years
History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least  years
Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix); if there is a history of prior malignancy, the patient must be disease-free for >= -years; patients whose lymphoma has transformed from a less aggressive histology remain eligible
Active second malignancy or history of a previous second malignancy within the last  years. \r\n* Exceptions include the following permitted conditions  provided a complete remission was achieved at least  years prior to initiating protocol-indicated treatment and no additional therapy (with the exception of allowable anti-estrogen/androgen therapy or bisphosphonates) is ongoing or required during the trial period: non-melanoma skin cancers (e.g. basal or squamous cell); superficial bladder cancer; or carcinoma in situ of the prostate, cervix, or breast.
History of active malignancy other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast).
Patients with a history of prior malignancy with the exception of non-melanoma skin cancer, carcinoma in situ of the cervix, in situ carcinoma of the bladder, or other malignancy that has undergone potentially curative therapy with no evidence of disease for the last >  years and that is deemed by the investigator to be a low risk for recurrence
History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least  years
Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least  years
Any other malignancy from which the patient has been disease-free for less than  years, except for non-melanoma skin cancer, or in situ carcinoma of any site
Active concurrent malignancy (except non-invasive non-melanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia); if there is a history of prior malignancy, the patient must be disease-free for >= -years at the time of study entry
Active concurrent malignancy (except non-melanoma skin cancer, prostatic intraepithelial neoplasia, or carcinoma in situ of the cervix); if there is a history of prior malignancy, the patient must be disease-free for ?  years; patients whose lymphoma has transformed from a less aggressive histology remain eligible
FOR ALL PHASES (Ib AND II): History of any other malignancy within the past  years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix
Patients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for >=  years
Prior malignancy except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than  years prior to st dose of investigational drug
History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least  years
Presence of second active tumor, other than non-melanoma skin cancer, carcinoma in situ of the cervix, or Kaposis sarcoma (KS) that requires systemic therapy
Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a -year disease-free interval.
Other primary malignancy within past  years except carcinoma in situ of the cervix or urinary bladder or non-melanoma skin cancer
Subjects with a history of prior malignancy with the exception of non-melanoma skin cancer, carcinoma in situ of the cervix, in situ carcinoma of the bladder, or other malignancy that has undergone potentially curative therapy with no evidence of disease for the last >  years and that is deemed by the investigator to be a low risk for recurrence
Another primary malignancy other than CML within the past  years except non-melanoma skin cancer, or carcinoma in situ of the cervix.
Active concurrent malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix, low risk prostate cancer); if there is a history of prior malignancy, the patient must be disease-free for >=  years
Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, early stage prostate cancer, or carcinoma in situ of the cervix; patients with a previous non-pancreatic, non-periampullary malignancy without evidence of disease for >  years will be allowed to enter the trial
Any other malignancy from which the patient has been disease-free for less than  years, except for non-melanoma skin cancer, controlled localized prostate cancer, in situ carcinoma of any site
Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, early stage prostate cancer, or carcinoma in situ of the cervix; patients with a previous non-pancreatic, non-periampullary malignancy without evidence of disease for >  years will be allowed to enter the trial
History of another malignancy within the last five years except non-melanoma skin cancer, carcinoma insitu of uterine cervix, uteri, and breast from which the patient has been disease free for at least  years; second primary breast cancers are allowed regardless of the number of years since they were first diagnosed
Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for >=  years will be allowed to enter the trial
Patients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uterus, or breast from which the patient has been disease free for =<  years
Other malignancy that is either active or for which patient has received treatment in the last five years excluding non-melanoma skin cancer and carcinoma in situ of the cervix
History of second malignancy, other than non-melanoma skin cancer or in situ carcinoma of the cervix or the breast, unless the tumor was successfully treated at least  years before trial entry and with no evidence of relapse or active cancer
Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for >=  years will be allowed to enter the trial
Any other malignancy from which the patient has been disease-free for less than  years, except for non-melanoma skin cancer, in situ carcinoma of any site
Patients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uterus, or breast, unless the patient has been disease free for >=  years
Any other diagnosis of malignancy or evidence of malignancy (except non-melanoma skin cancer, in-situ carcinoma of the cervix) within  years prior to screening for this study
Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, early stage prostate cancer, or carcinoma in situ of the cervix; patients with a previous non-pancreatic, non-periampullary malignancy without evidence of disease for >  years will be allowed to enter the trial
Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease.
Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a -year disease-free interval.
Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix, bladder, or prostate not requiring treatment. Subjects with previous malignancies are eligible provided that they have been disease-free for ? years
Had prior malignancy other than carcinoma in situ of the cervix or non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least  years previously with no subsequent evidence of recurrence. If the patient has a medical history of a previous tumor that is not included in this criteria and that the Investigator feels is irrelevant for the objectives of the study, it should be evaluated with the Sponsor or Medical Monitor.
Prior additional malignancy within  years except for non-melanoma skin cancer, carcinoma in situ of the breast, oral cavity or cervix.
Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a -year disease-free interval, or are deemed at low risk for recurrence by his/her treating physician.
Prior secondary malignancy <  years prior to consent (except non-melanoma skin cancer or carcinoma in situ of the uterine cervix) or receiving other specific treatment for this cancer (monoclonal antibody, small molecule pathway inhibitor)
Other invasive cancer within  years before randomization; exceptions are colonic polyps, non-melanoma skin cancer or carcinoma-in-situ of the cervix
TREATMENT: Patients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for >  years
Previous malignant disease being disease-free for less than  years (except carcinoma in situ [CIS] of the cervix and non-melanoma skin cancer)
Patient with known active invasive malignancy other than NSCLC (exceptions: non-melanoma skin cancer or carcinoma in-situ of the cervix or bladder)
A prior or concurrent malignancy of any other site or histology unless the patient has been disease-free for >=  years except for non-melanoma skin cancer and/or stage Ta prostate cancer or carcinoma in situ of the uterine cervix
Patients must NOT have previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:\r\n* Non-melanoma skin cancer, in situ cervical cancer, breast cancer in situ, or superficial bladder cancer (noninvasive papillary carcinoma or carcinoma in situ)\r\n* Prior malignancy completely excised or removed and patient has been continuously disease free for >  years
PHASE II: Patients must NOT have previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:\r\n* Non-melanoma skin cancer, in situ cervical cancer, breast cancer in situ, or superficial bladder cancer (noninvasive papillary carcinoma or carcinoma in situ)\r\n Prior malignancy completely excised or removed and patient has been continuously disease free for >  years
Presence of second active tumor, other than non-melanoma skin cancer, carcinoma in situ of the cervix, or Kaposis sarcoma (KS) that requires systemic therapy
Second primary malignancy within the past  years (except non-melanoma skin cancer, in situ carcinoma of the cervix, breast cancer)
Previous history of invasive malignancy (except non-melanoma skin cancer) unless the patient has been disease free for at least  years prior to study entry (or first day of chemotherapy for patients having started chemotherapy prior to first step registration); patients with a previous history of carcinoma in situ are eligible
Concurrent or prior malignancy in the last  years other than non-melanoma skin cancer and in-situ carcinoma of the cervix or thymoma
Previous (within the past  years) or concurrent malignancy diagnosis (expect non-melanoma skin cancer or in situ carcinoma of the cervix)
Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease.
History of concurrent or previously non-breast malignancies except for appropriately treated () non-melanoma skin cancer and () in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease-free >/=  years
A prior or concurrent malignancy of any other site or histology unless the patient has been disease-free for >=  years except for non-melanoma skin cancer and/or stage Ta prostate cancer or carcinoma in situ of the uterine cervix or a urothelial carcinoma of the upper urinary tract stage pTa, pTis or pT that has not been free of disease after treatment for more than a  year period
History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least  years
Patients with a history of another malignancy that progressed or required treatment within the past year prior to registration are not eligible for participation; Note: the exceptions to this include non-melanoma skin cancer or excised carcinoma in situ of the cervix
Second primary malignancy within  years (not including in situ carcinoma of the cervix, non-melanoma skin cancer or low-grade [Gleason score =< ] localized prostate cancer) at the time of consideration for study enrollment
Patients who have a history of another primary malignancy from which the patient has been disease free for <  year; with the exceptions of non-melanoma skin cancer and carcinoma in situ of the cervix, uteri, or breast
Patients who have a history of another primary malignancy within  years, with the except non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for >=  years
History of second malignancy, other than non-melanoma skin cancer or in situ carcinoma of the cervix or the breast, unless the tumor was successfully treated at least  years before trial entry and with no evidence of relapse or active cancer
Patients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for greater than or equal to  years
Concurrent active malignancy other than nonmelanoma skin cancer or carcinoma in situ of the cervix, bladder, or prostate not requiring treatment. Subjects with previous malignancies are eligible provided that they have been disease free for ? years
Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix); if there is a history of prior malignancy, the patient must be disease-free for >= -years; patients whose lymphoma has transformed from a less aggressive histology remain eligible
Patients must NOT have previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:\r\n* Non-melanoma skin cancer, in situ cervical cancer, or breast cancer in situ OR\r\n* Prior malignancy completely excised or removed and patient has been continuously disease free for >  years OR\r\n* Prior malignancy cured by non-surgical modalities and patient has been continuously disease free for >  years
History of another malignancy or concurrent malignancy including prior malignant melanoma. Exceptions to this include: Patients who have been disease-free for  years or patients with a history completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ, multiple primary melanomas, or other malignancies for which the patient has been disease free for >  years.
Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix); if there is a history of prior malignancy the patients must be disease free and off treatment for >=  years
Patients who have a history of another primary malignancy and are off treatment =<  years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix
Patients with a history of other primary cancers are eligible if the pathology report confirming the diagnosis of primary breast cancer is available and the other primary cancer was curatively treated with a -year disease-free interval\r\n* Patients with non-melanoma skin cancer are eligible; however, patients with squamous cell carcinoma of other sites (except in-situ cervix) are not eligible
No other diagnosed malignancy (except non-melanoma skin cancer or cervical carcinoma in situ, which are allowable), unless the patient has been disease-free for at least  years
Second primary malignancy (skin cancer other than melanoma allowed) that is disease free for less than  years
Patients with a prior or concurrent malignancy (other than non-melanoma skin cancer or carcinoma in-situ of the cervix) are ineligible unless the previous cancer was treated  years or more prior to the current tumor and the patient has remained continually disease free
Patients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for >=  years
History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least  years
Second primary malignancy with the following exceptions which are allowed:\r\n* Carcinoma in situ of the cervix\r\n* Non-melanoma skin cancer\r\n* History of low-grade (Gleason score =< ) localized prostate cancer even if diagnosed <  years prior to registration\r\n* Treated stage I breast cancer even if diagnosed =<  years prior to registration\r\n* Other prior malignancy (including melanoma) allowed if it was diagnosed and definitively treated at least  years previously with no subsequent evidence of recurrence
Patients with another malignancy in the past  years except: curatively treated non-melanoma skin cancer, or carcinoma in situ (either cervix or breast) that does not require further treatment.
Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix; subjects with previous malignancies are eligible provided that they have been treated with curative intent and remain disease free for  years or more
Any active malignancy (unrelated, non-hematological malignancy) diagnosed within the past  months of starting the study drug (other than curatively treated carcinoma-in-situ of the cervix or non-melanoma skin cancer)
No active concurrent malignancy is allowed, except inactive non-melanoma skin cancer or in situ carcinoma of the cervix; prior cancer is eligible only if the patient has been disease-free for >=  years
History of any malignancy; exceptions: non?melanoma skin cancer or carcinoma in situ (CIS) of the cervix
History of cancer treatment =<  months prior to randomization, excepting hormonal therapy (except treatment for non-melanoma skin cancer or carcinoma-in-situ of the cervix)
Patients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for >=  years
Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for >  years will be allowed to enter the trial
Patients who have a history of another primary malignancy, with the exceptions of: non-melanoma skin cancer, and carcinoma in situ of the cervix, uteri, or breast from which the patient has been disease free for ? years;
Concurrent active malignancy other than non-melanomatous skin cancer or carcinoma in-situ of the cervix, unless treatment for the previous cancer was completed >  years prior to study entry and patient has remained disease-free
Malignancy other than non-melanoma skin cancer, carcinoma in situ, or low grade prostate cancer for which watch-and-wait approach is standard of care, unless disease free for at least  years
Diagnosis of any other invasive cancer (other than non-melanoma skin cancer or carcinoma in situ of the cervix) that requires ongoing treatment or for which there is evidence of active disease
History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least  years