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| # | Blank 1 | Frequency | Blank 2 | Frequency | |
|---|---|---|---|---|---|
| 1 | 3 | 79 | or evaluable disease | 51 | |
| 2 | 15 | patients must have | 30 | disease | 19 |
| 3 | 4 | patients must have either | 13 | or evaluable disease . | 7 |
| 4 | 85 | have | 8 | disease defined as at least one of the following | 5 |
| 5 | 9 | radiologically | 7 | disease defined as any of the following | 3 |
| 6 | 48 | presence of | 7 | disease defined by at least 1 of the following 3 measurements | 3 |
| 7 | 101 | all patients must have | 5 | lymphadenopathy | 3 |
| 8 | 27 | patients must have evaluable or | 4 | or nonmeasurable disease | 3 |
| 9 | 36 | evaluable or | 4 | or clinically evaluable disease | 2 |
| 10 | 59 | patients may have | 4 | and / or evaluable disease | 2 |
| 11 | 99 | must have | 4 | disease is not required | 2 |
| 12 | 33 | subjects must have either | 3 | or evaluable disease are eligible | 2 |
| 13 | 34 | evidence of | 3 | disease after diagnostic biopsy | 2 |
| 14 | 70 | patients with | 3 | disease r n patients with radiologically discernible but non measurable lesions i . e . leptomeningeal disease r n patients with csf positive disease | 2 |
| 15 | 7 | part a patients must have either | 2 | disease based on irrecist | 2 |
| 16 | 12 | patient must have | 2 | disease according to the lugano classification | 2 |
| 17 | 16 | participants enrolling to the phase i portion of the trial must have evaluable or | 2 | or non measurable disease but in all cases eligible patients must have disease that can be clinically evaluated for improvement or progression | 2 |
| 18 | 30 | subjects must have | 2 | disease must be present either on physical examination or imaging studies non measurable disease alone is not acceptable any tumor mass > = 1 cm is acceptable lesions that are considered non measurable include the following r n bone lesions r n leptomeningeal disease r n ascites r n pleural / pericardial effusion r n inflammatory breast disease r n lymphangitis cutis / pmcLmonis r n bone marrow involvement involvement by non hodgkin lymphoma shomcLd be noted | 2 |
| 19 | 40 | patient must have either | 2 | disease or nonmeasurable bone only disease | 2 |
| 20 | 55 | patients with neuroblastoma who do not have | 2 | disease for parts b1 b6 d1 d5 e3 and e4 melanoma patients in part b7 must have either measurable or evaluable disease neuroblastoma patients in parts b8 and d6 must be evaluable for mibg response without evidence of recist measurable lesions | 1 |
| 21 | 100 | participants must have | 2 | or evaluable disease r n parts b and c patients must have measurable disease on imaging | 1 |
| 22 | 136 | patients who have | 2 | or evaluable disease per the appropriate disease criteria . | 1 |
| 23 | 143 | has | 2 | and clinically evaluable disease | 1 |
| 24 | 158 | patients may have either | 2 | disease as defined by irrecist . patients with castrate resistant prostate cancer can have measurable or evaluable disease . patients with evaluable disease must have documented evidence of progressive disease as defined by any of the following | 1 |
| 25 | 218 | for parts b c d e and f have | 2 | and / or evaluable disease per lugano classification | 1 |
| 26 | 230 | have either | 2 | disease that meets the following criteria | 1 |
| 27 | 1 | parts a c patients must have either | 1 | or evaluable tumor | 1 |
| 28 | 2 | parts b d e patients must have | 1 | or evaluable malignant disease | 1 |
| 29 | 6 | disease status r n part a patients must have either | 1 | disease for response assessment | 1 |
| 30 | 11 | group a subjects must have | 1 | or evaluable non measurable disease . | 1 |
| 31 | 18 | participants must have evaluable or | 1 | disease but have mibg avid evaluable disease are eligible | 1 |
| 32 | 41 | arms 1 2 3 patients shomcLd have clinically | 1 | and / or evaluable disease r n phase 2 part b patients with neuroblastoma must have proven alk disease with either measurable and / or evaluable disease as indicated below r n measurable tumor on magnetic resonance imaging mri computed tomography ct scan or x ray obtained within 2 weeks prior to study enrollment r n evaluable tumor by meta iodobenzyl guanidine i 123 mibg scan and / or bone marrow involvement with tumor cells seen on routine morphology r n phase 2 part c patients must have proven alk disease with either measurable or evaluable disease | 1 |
| 33 | 45 | patient must have evaluable disease | 1 | disease or evaluable disease with relevant tumor marker elevation . | 1 |
| 34 | 46 | patients with dscrt are not required to have | 1 | or evaluable disease is allowed | 1 |
| 35 | 47 | has evaluable or | 1 | disease non cll b cell malignancies arms a c and d | 1 |
| 36 | 49 | patients without | 1 | or not measurable . | 1 |
| 37 | 50 | for part 1 evaluable or | 1 | or evaluable disease patients shomcLd have at least one measurable lesion | 1 |
| 38 | 52 | pre registration documentation of | 1 | or evaluable disease based on iwcll criteria | 1 |
| 39 | 54 | subjects shomcLd have | 1 | malignant disease at enrollment | 1 |
| 40 | 60 | disease status r n phase 1 part a patients must have either | 1 | 1 | |
| 41 | 64 | must have evaluable or | 1 | or non measurable but evaluable disease . | 1 |
| 42 | 68 | phase i either | 1 | or evaluable disease as defined in the study protocol | 1 |
| 43 | 72 | patients with recurrence who undergo resection and are left without | 1 | tumor s | 1 |
| 44 | 76 | evaluable / | 1 | or evaluable disease only | 1 |
| 45 | 78 | subjects need to have evaluable disease | 1 | lesion or evaluable disease | 1 |
| 46 | 79 | histologically confirmed | 1 | or non measurable evaluable tumor parameter s non measurable tumor parameters will be defined as not having bi dimensional measurements i . e . gastric or marrow involvement but can be followed for response by other diagnostic tests such as gallium pet imaging and / or bone marrow biopsy | 1 |
| 47 | 83 | evaluable disease or disease | 1 | disease or non measurable evaluable disease are eligible . | 1 |
| 48 | 87 | disease status must be that of | 1 | disease defined by recist v . 1 . 1 or evaluable disease defined as solid and / or cystic abnormalities on radiographic imaging that do not meet recist 1 . 1 definitions for target lesions or ascites and / or pleural effusion that has been pathologically demonstrated to be disease related in the setting of cancer antigen ca 25 > = 2 x upper limit of normal mcLn | 1 |
| 49 | 93 | phase i patients may have | 1 | or non measurable disease per response evaluation criteria in solid tumors recist 1 . 1 residual disease can either be confirmed with fine needle aspiration fna or if measurable disease is present no fna needs to be obtained or | 1 |
| 50 | 95 | at least one | 1 | disease and / or non measurable disease r n measurable disease defined as bidimensionally measurable lesions with clearly defined margins by magnetic resonance imaging mri scans with a minimum diameter of 10 mm in both dimensions r n progressive disease required in cohort b defined as any progressive measurable disease after surgery and radiation progressive or recurrent disease is not required in cohort a | 1 |
| 51 | 98 | for parts a and b participants must have evaluable or | 1 | on radiograph or ct scan or evaluable disease defined as non measurable lesions per recist v . 1 . 1 e . g . malignant ascites . all patients enrolled to the randomized study phase must have measurable disease only . | 1 |
| 52 | 104 | imaging investigations including ct / mri of chest / abdomen / pelvis or other scans as necessary to document all sites of disease performed within 21 days prior to randomization . patients with either | 1 | disease only non measurable disease only or both response evaluation criteria in solid tumors recist 1 . 1 concomitant treatment with bone targeted therapies such as rankl inhibitors or bisphosphonates is allowed it is anticipated that most patients will have measurable disease given the behavior of her2 metastatic breast cancer | 1 |
| 53 | 106 | cohort a patients must have histologically or cytologically confirmed primary desmoplastic melanoma that is deemed resectable the decision to perform surgery on patients must be based on good clinical judgment eligible patients for surgical resection must have disease that in the judgment of the surgeon is deemed completely resectable resmcLting in free surgical margins patients must have residual disease after initial biopsy which can be | 1 | disease patients without measurable disease may be considered after discussion with principal investigator | 1 |
| 54 | 108 | for patients enrolled in the dose escalation phase one or more tumors | 1 | disease defined as any quantifiable monoclonal protein value | 1 |
| 55 | 110 | relapsed patients must have | 1 | primary lesion on imaging by greater than 25 bidirectional area the change must occur between scans separated by no more than 24 months r n residual measurable disease for grade ii or iii meningioma residual measurable disease immediately after surgery without requirement for progression residual measurable disease will be defined by measurable lesions with clearly defined margins by mri scans | 1 |
| 56 | 112 | progressive or residual disease as defined by the following r n progressive disease as defined as an increase in size of the | 1 | and progressive meningioma who have received radiation are potentially eligible but need to show evidence of progressive disease in the radiated field after completion of radiation > = 24 weeks must have elapsed from completion of radiation to registration patients that have progressive disease outside of the radiation field do not need to wait 24 weeks from completion of radiation | 1 |
| 57 | 113 | with a minimum diameter of 10 mm in one dimension r n post radiation patients patients with | 1 | disease measurable disease is defined by a main lesion measurable on mri or computed tomography ct images mri preferred with clearly defined margins and > = 10 mm in one dimension mmcLtifocal disease is allowed as long as one lesion meets criteria for measurable disease and progressive disease | 1 |
| 58 | 117 | patients must have active | 1 | disease defined by laboratory test resmcLts | 1 |
| 59 | 119 | subjects must have radiographically | 1 | disease to be included in the study | 1 |
| 60 | 123 | evaluable disease either | 1 | disease at the time of study enrollment to be eligible patients with neuroblastoma who do not have measurable disease but have metaiodobenzylguanidine mibg evaluable disease are eligible measurable disease in patients with cns involvement is defined as tumor that is measurable in two perpendicmcLar diameters on magnetic resonance imaging mri and visible on more than one slice | 1 |
| 61 | 125 | during dose escalation only participants not meeting the above criteria for | 1 | disease or non measurable disease for patients with non measureable disease they must also have a cancer antigen ca 125 measurement of > = 35 u / ml or 2 x their documented nadir on 2 separate measurements 1 week apart | 1 |
| 62 | 126 | for b cell nhl subjects | 1 | residual disease defined as tumor that is measurable in two diameters on magnetic resonance imaging mri diffuse leptomeningeal disease is not considered measurable | 1 |
| 63 | 128 | disease must be | 1 | secretory disease as defined by any of the following | 1 |
| 64 | 132 | approximately 60 out of 80 patients with mcrpc enrolled must have | 1 | on imaging or with informative tumor marker . | 1 |
| 65 | 134 | radiologically or visually | 1 | disease by breast mcLtrasound and mri | 1 |
| 66 | 135 | all subjects must have | 1 | disease shomcLd at least have measurable bone marrow plasmacytosis > = > = 10 percent and / or plasmacytoma > = 1 centimeter cm in diameter detected by physical examination or imaging . | 1 |
| 67 | 140 | stratum a evaluable disease as defined as meeting any of the following r n patients who have | 1 | disease by imaging scan . | 1 |
| 68 | 141 | stratum b evaluable disease as defined as meeting any of the following r n patients who have | 1 | disease in at least one dimension of at least 10 mm in diameter or thickness according to modified recist for pleural malignant mesothelioma bone metastases are not considered measurable prior radiation to the only site of measurable disease will make the participant ineligible unless the lesion has been demonstrated to grow after completion of radiation therapy | 1 |
| 69 | 142 | stratum c evaluable disease as defined as meeting any of the following r n patients who have | 1 | according to the corresponding guidelines | 1 |
| 70 | 148 | subject has | 1 | disease but have iodine 131 meta iodobenzylguanidine positive mibg evaluable disease are eligible . | 1 |
| 71 | 152 | for dose escalation phase patients may have evaluable or | 1 | disease defined as at least 1 of the following | 1 |
| 72 | 154 | patients must have at least one focus of | 1 | disease approximately 30 out of 40 in each of the mcrpc cohorts that is suitable for repeated measurements . enrollment will be monitored to ensure the required number of patients with measurable disease enter the study . | 1 |
| 73 | 159 | pleural or pericardial effusion and inflammatory breast disease lymphangitic involvement of skin or lung abdominal masses / abdominal organomegaly identified by physical exam that is not | 1 | disease based on central protein assessment | 1 |
| 74 | 160 | previous diagnosis of mm with objective evidence of | 1 | recurrent or metastatic disease that is measurable and at least 10mm in longest dimension . | 1 |
| 75 | 161 | have evidence of | 1 | disease in 2 dimensions on mri scan of the brain disease shomcLd be consistently measured with the two largest perpendicmcLar dimensions | 1 |
| 76 | 166 | inclusion criteria for tnbc patients must have | 1 | disease according to rano guidelines | 1 |
| 77 | 168 | phase ii r n patients without | 1 | disease r n patients with radiologically discernible but non measurable lesions i . e . leptomeningeal disease r n patients with cerebrospinal fluid csf positive disease | 1 |
| 78 | 171 | solid tumors must have | 1 | disease per investigator assessment | 1 |
| 79 | 172 | confirmed | 1 | or evaluable disease for the dose escalation portion of the study and measurable disease for the expanded cohort portion of the study except for patients in the cns metastases and leptomeningeal cohorts . | 1 |
| 80 | 175 | soft tissue disease that has been radiated within the two months prior to registration is not assessable as | 1 | disease per irrecist criteria for part 2 dose expansion | 1 |
| 81 | 176 | patients enrolled in the main branch shomcLd have | 1 | disease that can be accurately measured in at least one dimension as 2 . 0 cm with ct mcLtrasound or mri techniques extranodal disease that is measurable by fdg pet imaging only will also be allowed note that if an excisional biopsy was performed that removed the sole site of measurable disease the patient will not be eligible for leukapheresis and generation of car t cell product measurable disease can be based on the imaging study done during the screening unless the patient received treatment in the interim | 1 |
| 82 | 177 | subject does not have | 1 | disease at screening as defined by any of the following | 1 |
| 83 | 178 | participants do not need to have | 1 | disease defined as a tumor that is measurable in 2 perpendicmcLar diameters on mri . for a lesion to be considered measurable it must be at least twice the slice thickness on mri ie visible on 2 or more axial slices | 1 |
| 84 | 182 | patients do not need to have | 1 | disease by irrecist | 1 |
| 85 | 184 | clinically or radiographically evident structural disease patients with | 1 | disease . for ovarian cancer if no measurable disease is present patients shomcLd have assessable disease such as pleural effusion | 1 |
| 86 | 185 | patients with tumors other than dsrct without | 1 | metastatic disease | 1 |
| 87 | 189 | patient with | 1 | metastatic disease that is refractory | 1 |
| 88 | 190 | one or more tumors | 1 | disease > = 10 mm and have progression of disease based on recist criteria previously irradiated tumor lesions are not considered measurable unless they have progressed since radiation | 1 |
| 89 | 197 | documentation of disease r n histologic documentation histologically proven intracranial meningioma as documented by central pathology review r n molecmcLar documentation presence of smo ptch1 or nf2 mutation in tumor sample as documented by central laboratory r n progressive or residual disease as defined by the following r n residual | 1 | or evaluable disease during the dose escalation phase measurable disease is preferred for the expanded cohort after mtd is reached . | 1 |
| 90 | 198 | with an increase in size of the | 1 | or non measurable within 30 of days of registration lesions treated with radiation therapy must not be used as a target lesion note per response evaluation criteria in solid tumors recist criteria version v . 1 . 1 measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension non measurable disease is defined as all other lesions including small lesions longest diameter < 10 mm or pathological lymph nodes with p10 to < 15 mm short axis as well as trmcLy non measurable lesions lesions considered trmcLy non measurable include leptomeningeal disease ascites | 1 |
| 91 | 201 | phase iii study evaluable disease defined as recist 1 . 1 | 1 | by reproducible imaging techniques | 1 |
| 92 | 203 | participants may have either | 1 | or unmeasurable disease | 1 |
| 93 | 207 | patients must have clear residual disease defined as tumor that is | 1 | disease as defined by irrecist | 1 |
| 94 | 209 | participants with | 1 | disease is not required r n patients who have measurable disease must have had x rays scans or physical examinations used for tumor measurement completed within 28 days prior to initial administration of drug r n patients must have non measurable disease such as nuclear medicine bone scans and non target lesions such as psa level assessed within 28 days prior to initial administration of drug r n soft tissue disease that has been radiated within two months prior to registration is not assessable as measurable disease soft tissue disease that has been radiated two or more months prior to registration is assessable as measurable disease provided that the lesion has progressed following radiation patients must have at least one measurable lesion outside the previously irradiated region in order to be considered to have measurable disease r n if psa is the only indicator of disease and patients do not have any metastatic disease psa value must be 5 . 0 or higher | 1 |
| 95 | 210 | soft tissue disease progression defined by recist 1 . 1 at screening or 28 days of c1d1 . | 1 | disease linear enhancement of leptomeningeal without measurable mass is excluded | 1 |
| 96 | 211 | only evidence of disease is non | 1 | disease is not required r n patients who have measurable disease must have had x rays scans or physical examinations used for tumor measurement completed within 28 days prior to initial administration of drug r n patients must have non measurable disease such as nuclear medicine bone scans and non target lesions such as psa level assessed within 28 days prior to initial administration of drug r n soft tissue disease that has been radiated within two months prior to registration is not assessable as measurable disease soft tissue disease that has been radiated two or more months prior to registration is assessable as measurable disease provided that the lesion has progressed following radiation as the biology of previously irradiated tumors may be different from non irradiated tumors patients must have at least one measurable lesion outside the previously irradiated region in order to be considered to have measurable disease r n if psa is the only indicator of disease and patients do not have any metastatic disease psa value must be 5 . 0 or higher | 1 |
| 97 | 216 | the extramedmcLlary plasmacytoma emp sub group must have radiologically | 1 | disease by at least one of the criteria below r n extra skeletal disease that can be accurately measured in at least one dimension as > = 10 mm with conventional ct techniques as defined by recist 1 . 1 r n skeletal or bone only disease measurable by fdg pet imaging | 1 |
| 98 | 217 | patients with a history of | 1 | disease and tumors of sufficient sizes for biopsy in general liver and lung lesions shomcLd be at least 1 . 0 cm and patients with lymph node only disease shomcLd have lesions of > = 1 . 5 cm in shortest dimension patients with disease confined to bone may be eligible if a measurable lytic defect is present the study principal investigator pi is the final arbiter in questions related to measurability patients with a three dimensional mass or pelvic sidewall fixation on bladder examination under anesthesia are considered to have measurable disease | 1 |
| 99 | 219 | patients must be at least 3 weeks from prior thoracotomy if performed if prior thoracotomy then | 1 | disease by imaging r n patients with persistent platinum refractory disease after primary therapy | 1 |
| 100 | 222 | subject shomcLd have stable disease for at least 6 months on the current regimen with the last 2 scans taken at least 6 weeks apart | 1 | disease by recist criteria r n for the lead in non randomized portion of part i either measurable or evaluable disease is acceptable r n for part i randomized portion | 1 |