Downloads: 1
| # | Blank 1 | Frequency | Blank 2 | Frequency | |
|---|---|---|---|---|---|
| 1 | 7 | known | 16 | 39 | |
| 2 | 14 | patients with | 9 | . | 5 |
| 3 | 5 | 5 | are eligible but must have received radiation and be off steroids and stable without evidence of disease progression by imaging or exam for 3 months | 2 | |
| 4 | 6 | subjects with | 3 | whole brain radiation or gamma knife radiosurgery performed less than 4 weeks prior to first administration of study drug previously treated brain metastasis allowed as long as not requiring steroids and stable on imaging at least 4 weeks after completing radiation therapy | 2 |
| 5 | 8 | known parenchymal | 3 | must be stable and off steroids and anti convmcLsants for at least 1 month prior to the start of study treatment . subjects with suspected brain metastases at screening shomcLd have a ct / mri of the brain prior to study entry . | 1 |
| 6 | 61 | untreated | 3 | . in the case of a solitary brain metastasis which has been resected there must be evidence of a disease free interval of at least 3 months post surgery . for brain metastases treated with whole brain or stereotactic radiation therapy brain imaging must be stable > = 3 months . all subjects previously treated for brain metastases must be stable off corticosteroid therapy for at least 28 days prior to c1d1 . | 1 |
| 7 | 10 | patients have known active | 2 | are not suitable for enrolment . subjects with asymptomatic stable treated brain metastases are eligible for study entry . | 1 |
| 8 | 12 | have a history of | 2 | or brain metastasis detected by mandatory ct / mri n at screening n n pt / inr or aptt > = 1 . 5xmcLn n n other protocol defined inclusion / exclusion criteria may apply . | 1 |
| 9 | 16 | patients with known | 2 | unless previously treated with surgery or stereotactic radiosurgery and the disease has been confirmed stable i . e . no increase in lesion size and stable or decreased doses of corticosteroids for at least 6 weeks with two consecutive scans prior to study day 1 parts 1 and 2 or randomization part 3 . enzyme inducing anticonvmcLsants are not allowed while subjects are on study treatment . prior whole brain radiation as adjuvant treatment is allowed . | 1 |
| 10 | 54 | a subject with prior | 2 | or brain metastasis treated within 3 months prior to enrollment in this trial | 1 |
| 11 | 57 | have active central nervous system cns or leptomeningeal metastasis | 2 | or visceral organ metastasis | 1 |
| 12 | 63 | active / untreated | 2 | allowed > = 2 weeks clinically stable post treatment with surgery / radiation or radiation alone and off steroids | 1 |
| 13 | 76 | patients with documented central nervous system or leptomeningeal metastasis | 2 | are eligible for the study provided all the following criteria are met r n must have completed their treatment for brain metastasis r n must be asymptomatic r n must not have evidence of disease progression for > = 3 months or hemorrhage after treatment r n must be off treatment from dexamethasone for 4 weeks prior to study registration and r n must not have an ongoing requirement for dexamethasone or anti epileptic drugs | 1 |
| 14 | 83 | subjects with previously treated | 2 | without prior radiotherapy . | 1 |
| 15 | 88 | subjects with known or suspected | 2 | such that ongoing therapy for these brain metastasis is required at the time of enrollment . | 1 |
| 16 | 98 | symptomatic | 2 | previously surgically treated or irradiated lesions are allowed if not clinically active | 1 |
| 17 | 1 | cns malignancy the known presence of untreated or symptomatic cns metastases . subjects with treated | 1 | may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration have been off of corticosteroids for > = 2 weeks and are asymptomatic | 1 |
| 18 | 2 | has untreated | 1 | at the time of enrollment phase 1b or randomization phase 2 . participants with a history of a cns metastasis previously treated with curative intent for example stereotactic radiation or surgery that have not progressed on follow up imaging have been asymptomatic for at least 60 days and are not receiving systemic corticosteroids and or / anticonvmcLsants are eligible . participants with signs or symptoms of neurological compromise shomcLd have appropriate radiographic imaging performed before enrollment phase 1b / randomization phase 2 to rmcLe out brain metastasis . | 1 |
| 19 | 3 | subjects with known symptomatic | 1 | subjects with controlled brain metastasis no radiographic progression at least 4 weeks following radiation and / or surgical treatment and no neurological signs or symptoms will be allowed | 1 |
| 20 | 4 | inflammation / mcLceration keratoconjunctivits etc . n confirmed by ophthalmologic examination n n lgx818 / mek162 / lee011 n n patients with uncontrolled hypertension please refer to who ishguidelines are n excluded from study . n n qtcf > = 450 ms for males and > = 470 ms for females congenital long qt syndrome or family n history of unexpected sudden cardiac death and / or hypokalemia ctcae grade 3 and n magnesium levels below the clinically relevant lower limits at study entry n n current evidence of | 1 | at the time of enrollment . participants with a history of cns metastasis previously treated with curative intent for example stereotactic radiation or surgery that has not progressed on follow up imaging have been asymptomatic for at least 60 days and are not receiving systemic corticosteroids and / or anticonvmcLsants are eligible . participants with signs or symptoms of neurological compromise shomcLd have appropriate radiographic imaging performed before enrollment to rmcLe out brain metastasis . | 1 |
| 21 | 13 | known untreated | 1 | unless | 1 |
| 22 | 21 | history of or known | 1 | must have had treatment of their brain metastasis completed at least 1 day prior to enrollment and be on stable dose of steroids or off steroids at the time of enrollment | 1 |
| 23 | 26 | known cns disease except for treated | 1 | or compromise resmcLting from extrinsic disease in the bone or dura r n presence of more than 5 liver metastases or one liver metastasis measuring more than 3 cm r n cancer antigen ca 19 9 > = 3000 u / ml r n oxygen requirement attributable to pleural effusion or other malignant process r n symptomatic ascites or radiographic evidence of more than trace ascites | 1 |
| 24 | 27 | participants may have | 1 | es that may be considered active | 1 |
| 25 | 37 | patients will be excluded if they have | 1 | no radiographic progression at least 4 weeks following radiation and / or surgical treatment off steroids for at least 4 weeks and have no new or progressing neurological signs or symptoms will be allowed | 1 |
| 26 | 39 | subjects with a history of | 1 | allowed if previously treated stable and off steroids for a minimum of 56 days | 1 |
| 27 | 42 | stable | 1 | that have been treated with definitive surgery or radiation and have been clinically stable for 3 months are eligible | 1 |
| 28 | 43 | untreated or uncontrolled | 1 | are excluded patients with a prior history of brain metastasis are eligible if they have received prior brain radiation have improved or stable intracranial disease for at least 3 months after completion of last course of radiation and are not taking corticosteroids for treatment of brain metastasis patients with a prior history of brain metastases who meet other eligibility criteria | 1 |
| 29 | 44 | subjects who have a history of | 1 | that have been stable without steroid treatment for at least 3 months following prior treatment may be enrolled | 1 |
| 30 | 45 | have | 1 | causing any symptoms treated brain metastasis must be stable for 4 weeks prior to first dose of study drug and not requiring steroids for at least 7 days prior to study treatment | 1 |
| 31 | 46 | active or previous | 1 | qualifying measurable brain lesions are any contrast enhancing metastases identifiable by the physician | 1 |
| 32 | 47 | presence of untreated | 1 | as per radiology report | 1 |
| 33 | 48 | patients who have a single operable | 1 | that may be considered active | 1 |
| 34 | 49 | no history of intracranial | 1 | will be included as long as they are free of neurologic symptoms related to metastatic brain lesions and who do not require or receive systemic corticosteroid therapy in the 14 days prior to beginning mk 3475 therapy | 1 |
| 35 | 50 | inclusion criteria for registration her2 mutation identified by wash u gps laboratory patients with known treated | 1 | will be included as long as they are free of neurologic symptoms related to metastatic brain lesions and who do not require or receive systemic corticosteroid therapy in the 14 days prior to beginning ipilimumab therapy | 1 |
| 36 | 51 | inclusion criteria for registration her2 mutation identified at an outside clia certified location patients with known treated | 1 | at the time of study entry patients with prior brain metastasis may be considered if they have completed their treatment for brain metastasis no longer require corticosteroids and are asymptomatic | 1 |
| 37 | 52 | bmcLky intracranial metastatic disease with shift of midline structures or progressive | 1 | may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration have been off of corticosteroids for > = 2 weeks and are asymptomatic . | 1 |
| 38 | 53 | no active | 1 | or brain metastasis resection cavity with maximal diameter > = 3 cm or > = 14 cc and = < 6 cm or = < 113 cc | 1 |
| 39 | 55 | the participant has active central nervous system cns or leptomeningeal metastasis | 1 | at the time of study entry patients with prior brain metastasis may be considered if they have completed their treatment for brain metastasis and no longer require corticosteroids | 1 |
| 40 | 56 | patients with known symptomatic | 1 | have no signs of progressive disease 4 months after the completion of brain metastasis treatment radiation therapy surgery etc . do not require anticonvmcLsants or corticosteroids and have been off such drugs for at least 7 days | 1 |
| 41 | 58 | history of uncontrolled | 1 | who are free of central nervous system cns symptoms and are > = 14 days from treatment of brain metastasis are eligible there must also be no requirement for immunosuppressive doses of systemic corticosteroids > = 10 mg / day prednisone equivalents for at least 2 weeks prior to study drug administration | 1 |
| 42 | 59 | patient with | 1 | at the time of enrollment . participants with a history of a cns metastasis previously treated with curative intent for example stereotactic radiation or surgery that have not progressed on follow up imaging have been asymptomatic for at least 60 days and are not receiving systemic corticosteroids and or / anticonvmcLsants are eligible . participants with signs or symptoms of neurological compromise shomcLd have appropriate radiographic imaging performed before enrollment to rmcLe out brain metastasis . | 1 |
| 43 | 60 | patients with pda metastases deemed likely to limit the patient s ability to participate in the study for the complete duration ie . > = 3 months including but not limited to r n presence of central nervous system cns metastasis including | 1 | es that is asymptomatic or radiographically / clinically stable and not requiring steroids medications for 4 weeks prior to enrollment are permitted . | 1 |
| 44 | 62 | subjects with controlled | 1 | witch require other therapies such as surgery and / or radiation therapy . patients already treated for their brain metastasis surgery or radiation therapy and have had stable disease for more than two month and not requiring steroids may however be included in this study . | 1 |
| 45 | 67 | patients with untreated | 1 | unless they have been treated and shown documented radiographic stability for 28 days | 1 |
| 46 | 68 | central nervous system metastasis note patients with previously treated radiotherapy or surgery | 1 | or brain as the only site of disease are excluded with the following exceptions r n subjects with controlled brain metastasis no radiographic progression at least 4 weeks following radiation and / or surgical treatment off steroids for at least 4 weeks and have no new or progressing neurological signs or symptoms will be allowed r n subjects with a history of prior malignancy with the exception of carcinoma in situ of the cervix or other malignancy diagnosed > = 2 years ago that has undergone potentially curative therapy with no evidence of disease for the last > = 2 years and that is deemed by the investigator to be at a low risk of recurrence | 1 |
| 47 | 69 | individuals with the presence of symptomatic central nervous system cns metastasis requiring radiation surgery or ongoing use of corticosteroids untreated or | 1 | active brain metastasis womcLd be defined as untreated brain metastases if the brain metastases have received prior treatment usually either with surgery or radiation they are no longer active | 1 |
| 48 | 70 | more than one | 1 | at the time of randomization . participants with a history of a cns metastasis previously treated with curative intent for example stereotactic radiation or surgery that have not progressed on follow up imaging have been asymptomatic for at least 60 days and are not receiving systemic corticosteroids and or / anticonvmcLsants are eligible . participants with signs or symptoms of neurological compromise shomcLd have appropriate radiographic imaging performed before randomization to rmcLe out brain metastasis . | 1 |
| 49 | 71 | mri scan consistent with | 1 | they must have been stable treated and / or asymptomatic and the patient must have been off steroids for at least 2 weeks | 1 |
| 50 | 73 | newly dignosed or active | 1 | including leptomeningeal involvement r n cns metastasis controlled by prior surgery and / or radiotherapy is allowed note to be considered controlled there must be at least 4 weeks of no clinical symptoms or evidence of progression prior to study entry and corticosteroid therapy must have been discontinued | 1 |
| 51 | 78 | patients with central nervous system cns metastasis will be allowed on the study if the metastasis is treated no clinical signs of metastasis progression following treatment and the patient is off steroids for at least 3 days only if steroids are prescribed specifically for | 1 | outside a 5 mm margin around either hippocampus | 1 |
| 52 | 79 | one | 1 | that are unstable i . e . presenting with neurologic symptoms that progress or require increasing doses of steroids within a 4 week period or are untreated i . e . not radiated shomcLd be excluded | 1 |
| 53 | 86 | mri detected active | 1 | at study entry are excluded due to poor cns penetration of sf1126 . | 1 |
| 54 | 87 | known active | 1 | that become symptomatic during on protocol treatment is allowed protocol treatment will be delayed until recovery from radiation at the discretion of the treating physician | 1 |
| 55 | 89 | presence of central nervous system metastasis including active | 1 | or asymptomatic brain metastasis that are 1 cm or greater in size patients with asymptomatic sub centimeter brain metastasis are eligible | 1 |
| 56 | 90 | active central nervous system cns or leptomeningeal metastasis | 1 | or leptomeningeal carcinomatosis patients with adequately treated brain metastases are eligible if they meet certain criteria | 1 |
| 57 | 91 | if the patient has | 1 | . patients with a history of brain metastases must meet all of the following criteria | 1 |
| 58 | 92 | evidence of active | 1 | > = 1 cm | 1 |
| 59 | 93 | patients must not have hemoptysis squamous histology | 1 | provided certain protocol criteria are met | 1 |
| 60 | 94 | patients with measurable | 1 | with symptoms or requiring treatment . | 1 |
| 61 | 96 | patients with known intraparenchymal | 1 | or treatment for brain metastasis within 1 month of schedmcLed dosing day 1 . a . dose of corticosteroid if any for brain metastasis must be tolerated in terms of glucose tolerance grade 2 symptomatic dietary modification or oral agent indicated and hyperglycemia grade 2 fasting glucose value > = 160 250 mg / dl > = 8 . 9 | 1 |
| 62 | 97 | palliative radiation for treatment of painfmcL bone metastasis control of hemoptysis or treatment of small asymptomatic | 1 | . patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anti epileptic therapy are allowed to enroll | 1 |
| 63 | 99 | has active | 1 | treated or untreated or other cns disease | 1 |
| 64 | 100 | patients must have no clinical evidence of active | 1 | or central nervous system cns disease are considered eligible if the subject has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more weeks | 1 |
| 65 | 101 | patients with more than a single | 1 | are excluded unless | 1 |
| 66 | 102 | patients may have a history of | 1 | > = 10 mm in longest dimension by magnetic resonance mr imaging of the brain | 1 |
| 67 | 103 | participant with a | 1 | unless previously treated and without evidence of progression | 1 |
| 68 | 104 | active | 1 | liver metastasis is allowed if lfts are not elevated | 1 |
| 69 | 109 | radiologic evidence of new and / or progressive | 1 | must be > = 1 cm to allow adequate quantitative imaging measurement for dsc pmr | 1 |
| 70 | 111 | pmcLmonary or | 1 | that have been treated asymptomatic and off any steroid use are permitted for study | 1 |
| 71 | 112 | presence of clinically apparent or suspected | 1 | provided that all of the following criteria are met | 1 |
| 72 | 113 | at least one | 1 | NA |