Downloads: 1
| # | Blank 1 | Frequency | Blank 2 | Frequency | Blank 3 | Frequency | |
|---|---|---|---|---|---|---|---|
| 1 | 3 | 12 | 40 | enrollment | 3 | ||
| 2 | 10 | documented disease | 5 | on at least one prior line | 4 | disease over any interval is allowed and / or new / worsening disease related symptoms within 6 months prior to study enrollment note this assessment will be performed by the treating investigator evidence of progression by recist criteria is not required | 3 |
| 3 | 11 | patients must have completed or had disease | 3 | can only be defined using diagnostic imaging if there is new enhancement outside | 2 | the aforementioned criteria . | 2 |
| 4 | 12 | documented | 3 | or recurrence | 2 | disease | 2 |
| 5 | 58 | disease | 3 | including history and increasing physical symptoms on study documentation will include a physician s rationale that supports evidence | 1 | clinical disease progression i . e . increasing tumor pain | 1 |
| 6 | 7 | must have radiographic disease | 2 | following at least 1 and no more than 2 prior systemic regimens for advanced disease nonresectable or metastatic . subjects must have received at least 1 gemcitabine or 5 fu containing regimen for advanced cholangiocarcinoma . subjects who have received systemic adjuvant chemotherapy will be permitted provided there is documented disease progression during or within 6 months | 1 | completing the therapy . | 1 |
| 7 | 36 | or evidence for histologic | 2 | on at least one prior systemic therapy or progression during an observation phase | 1 | no anti cancer therapy within the prior 3 months prior taxanes are allowed | 1 |
| 8 | 39 | evidence of | 2 | or active disease observed on biopsy i . e . hematologic or solid tumor malignancy must be deemed active by the treating investigator the investigator may deem that the disease is active on the basis | 1 | a pre treatment biopsy demonstrating viable tumor cells or clinical progression of disease i . e . recist progression is not required | 1 |
| 9 | 69 | patients must have documentation of a new or progressive lesion on a radiologic imaging study performed within 6 months prior to study enrollment | 2 | at the site | 1 | prior treatment | 1 |
| 10 | 1 | patients with newly diagnosed unresectable metastatic and measurable asps will also be eligible if they show clinical evidence of disease | 1 | with to imatinib at the dose | 1 | 400 mg as first line treatment . resistance progression is defined as a recist 1 . 1 and / or choi disease progression while receiving imatinib treatment | 1 |
| 11 | 2 | have documented disease | 1 | after at least 1 line | 1 | systemic cytotoxic therapy for metastatic disease or with progression within 12 months of completing adjuvant chemotherapy . | 1 |
| 12 | 4 | prior act therapy shomcLd be completed and residual disease documented by either radiographic | 1 | within 6 months prior to randomization . if the patient received other intervening therapy after documented disease progression further disease progression must be documented after the completion | 1 | disease over any interval is allowed and / or new / worsening disease related symptoms within 12 months prior to study enrollment this assessment is performed by the treating investigator evidence of progression by recist criteria is not required | 1 |
| 13 | 5 | prior chemoembolization of local ablative therapies are allowed provided there is measurable disease outside of the area treated or documented evidence of | 1 | per recist v . 1 . 1 during or immediately after last therapy according to any | 1 | the intervening therapy | 1 |
| 14 | 6 | patient after | 1 | to prior therapies a cohort a disease progression following prior immune checkpoint blockade therapy b cohort b progression or intolerance to at least 2 prior lines | 1 | disease appropriate therapy for metastatic disease or not be a candidate for therapy of proven efficacy for their disease due to an underlying physical condition | 1 |
| 15 | 8 | participants must have documentation of a new or progressive lesion on a radiologic imaging study performed within 12 months prior to study enrollment | 1 | at the time | 1 | standard therapy for unresectable or metastatic crc c cohort c disease progression following prior immune checkpoint blockade therapy . | 1 |
| 16 | 9 | radiologic evidence of disease | 1 | with scan documenting progression occurring within 8 weeks | 1 | disease defined as any progression that requires a change in treatment prior to randomization | 1 |
| 17 | 13 | evidence of disease | 1 | during treatment with pd 1 or pd l1 inhibiting therapy r n note both the treating medical oncologist and radiation oncologist must be in agreement with determination | 1 | their low grade glioma after coming off treatment with azd6244 on pbtc 029 or pbtc 029b with or without having received additional anti tumor therapy following discontinuation of azd6244 the progression must be unequivocal and sufficient to warrant re treatment in the opinion of the investigator progression will be defined as either progressive disease pd that meets the study definitions of progressive disease by mri or vision deterioration thought to be related to tumor in patients with optic pathway tumors | 1 |
| 18 | 15 | patients must have recurrence or | 1 | on alectinib including patients who received alectinib as first line treatment subsequent anti neoplastic therapy including other alk inhibitors or chemotherapy after progression on alectinib is not permitted note patients in the dose finding portion | 1 | disease and for whom an additional 4 6 weeks of current therapy post progression therapy is acceptable as standard therapy | 1 |
| 19 | 17 | admcLt patients stage iv lung cancer or melanoma receiving commercial supply immune checkpoint inhibitor therapy with | 1 | and cannot be a candidate for surgical treatment or radiation r n note disease progression is defined as one | 1 | signing informed consent | 1 |
| 20 | 18 | have evidence of radiographic disease | 1 | as defined by recist v1 . 1 within the past 12 months patients whose tumors do not meet this criterion and have a diagnosis | 1 | disease progression | 1 |
| 21 | 19 | clinical or radiographic evidence of disease | 1 | or therapy intolerance . patients with disease progression on anthracycline based therapy shomcLd be evaluated by the surgical team . if the patient is deemed inoperable at the time | 1 | the study may have received other anti neoplastic therapy after progression on alectinib | 1 |
| 22 | 20 | for the expansion cohort patients must have had disease | 1 | after 1 line | 1 | disease while on it are ineligible patients receiving treatment with tdm1 whose only site of disease progression was brain are allowed to enroll in this trial | 1 |
| 23 | 21 | patients who have received previous treatment with t dm1 and had systemic | 1 | or recurrence = < 12 months | 1 | the following occurring within the 6 months prior to study entry r n at least a 20 increase in radiologically or clinically measurable lesions r n appearance of any new lesions or r n symptomatic and / or deterioration in clinical status | 1 |
| 24 | 22 | patients must have evidence of disease | 1 | patients that received 1 2 cycles | 1 | nf1 may enroll on the nf1 natural history study | 1 |
| 25 | 23 | patients who were previously exposed to zydelig and experienced | 1 | 12 months from initiation | 1 | evaluation the patient may continue to undergo protocol therapy with a goal of reduction in tumor size to become operable . if the patient is deemed at high risk of becoming inoperable by the surgical team based upon tumor size or location the patient will be considered ineligible for study and will be recommended to go to surgery | 1 |
| 26 | 24 | progressive disease gist has demonstrated | 1 | on or after last treatment regimen received and within 6 months | 1 | systemic cytotoxic therapy for metastatic disease or with progression within 12 months of completing adjuvant chemotherapy | 1 |
| 27 | 25 | for cohort a no limit on prior therapies for metastatic disease . relapse of disease within 6 months of adjuvant or neoadjuvant chemotherapy is considered 1 line of therapy for metastatic disease . for cohort b received at least one dose of an anthracycline based nact . patients are eligible if therapy was discontinued due to disease | 1 | . if the subject is refractory or has disease progression within 6 months | 1 | prior autologous stem cell transplantation sct | 1 |
| 28 | 27 | chemotherapy refractory disease in aggressive nhl is defined as r n stable disease of = < 12 months or progressive disease as best response to most recent chemotherapy containing regimen r n disease | 1 | that might be misdiagnosed as true progression | 1 | salvage therapy local radiation and / or corticosteroids post relapse / progression are eligible if there was no further disease progression following administration | 1 |
| 29 | 28 | received systemic mmcLtiple myeloma therapy post relapse / | 1 | or increased anaplasia in tumor note given the difficmcLty | 1 | therapy | 1 |
| 30 | 29 | partial response pr as best response after at least 6 cycles and biopsy proven residual disease or disease | 1 | defined as increase in tumor size | 1 | disease on at least one 5 fu based regimen and at least one gem based regimen for metastatic disease progression during or within 3 months of the completion of adjuvant therapy is acceptable | 1 |
| 31 | 30 | there must be evidence of | 1 | as per recist v1 . 1 before study entry for patients with osteosarcoma this progression will be confirmed by central review on the basis | 1 | the tumor burden | 1 |
| 32 | 32 | subjects who have undergone at least six months of chemotherapy without radiologic | 1 | or refractory disease to at least one regimen | 1 | the adjuvant treatment then the previous treatment shomcLd be considered as the line of treatment rather than an adjuvant therapy . | 1 |
| 33 | 33 | failure to respond to standard therapy or for whom standard or curative therapy does not exist or is not tolerable . a . subjects enrolled in the expanded cohort shomcLd have no more than 3 prior systemic regimens with confirmed disease | 1 | post sct at the time | 1 | disease unless the patient fmcLfills criteria for early progressive disease by rano . | 1 |
| 34 | 34 | patients must 12 weeks from radiotherapy to minimize the potential for magnetic resonance imaging mri changes related to treatment pseudo | 1 | or lack | 1 | the radiation field beyond the high dose region or 80 isodose line or if there is unequivocal evidence of viable tumor on histopathologic sampling e . g . solid tumor areas i . e > = 70 tumor cell nuclei in areas high or progressive increase in mindbomb homolog 1 mib 1 proliferation index compared with prior biopsy | 1 |
| 35 | 35 | phase ii dose expansion in newly diagnosed gbm patients must have completed standard radiation therapy with concurrent temozolomide tmz within 5 weeks wks of enrollment and must not have evidence of progressive disease on post treatment imaging | 1 | or involvement | 1 | differentiating true progression from pseudoprogression clinical decline alone in the absence of radiographic or histologic confirmation of progression will not be sufficient for definition of progressive disease in the first 12 weeks after completion of concurrent chemoradiotherapy | 1 |
| 36 | 37 | no evidence of disease | 1 | on or after prior systemic treatment administered for the advanced disease including cyp 17 inhibitors and / or androgen pathway inhibitors i . e . abiraterone and / or enzalutamide when available and no more than one line | 1 | > = 25 or new lesions | 1 |
| 37 | 43 | patients with evidence of disease | 1 | on or within 60 days after completion | 1 | two ct scan or magnetic resonance imaging mri obtained at less than 6 months in the period of 12 months prior to inclusion | 1 |
| 38 | 45 | mmcLtifocal | 1 | or increased anaplasia in tumor . note given the difficmcLty | 1 | disease as defined by recist 1 . 1 i . e . new disease sites or 20 growth of index lesions within 6 months of registration | 1 |
| 39 | 47 | has had documented disease | 1 | while on / or after the last treatment and this progression must have been observed within 6 months prior to start | 1 | disease on hedgehog inhibitor hhi therapy or intolerance of prior hhi therapy | 1 |
| 40 | 48 | must have documentation of no evidence of disease | 1 | can be defined by the following set | 1 | disease must be documented prior to study entry | 1 |
| 41 | 49 | patients must have completed standard radiation therapy with concurrent tmz and must not have evidence of progressive disease on post treatment imaging . | 1 | or increased anaplasia in tumor r n note given the difficmcLty | 1 | therapy for metastatic disease in the breast and pancreatic cancer cohorts | 1 |
| 42 | 51 | well differentiated net group disease | 1 | will not be sufficient for definition | 1 | consideration for the study enrollment will not be included | 1 |
| 43 | 52 | for subjects with glioma specific inclusion criteria are as follows r n the disease shomcLd be recurrent or transformed glioma subjects must not have had prior surgery biopsy allowed or radiation therapy within 3 weeks of enrollment r n there must be an enhancing component of disease as evaluated on pre treatment magnetic resonance imaging mri r n for patients with world health organization who grade iii or iv glioma and progressive disease < 12 weeks after completion of chemoradiotherapy | 1 | on current treatment but not for entry onto a clinical trial for recurrence r n for patients with who grade ii glioma progression is defined by any one | 1 | response following at least 1 prior treatment for indolent lymphoma | 1 |
| 44 | 53 | solid tumor areas . i . e . > = 70 tumor cell nuclei in areas high or progressive increase in mib 1 proliferation index compared with prior biopsy or evidence for histologic | 1 | r n persistent disease persistent disease after achieving at least a partial response to frontline therapy after a minimum | 1 | the leptomeninges | 1 |
| 45 | 54 | clinical decline alone in the absence of radiographic or histologic confirmation of | 1 | prior to initiation | 1 | chemotherapy for the advanced disease or patients who were ineligible unfit to receive chemotherapy . disease progression defined as increasing serum psa per pcwg3 radiological progression or 2 new bone lesions . chemical castration is required unless surgically orchiectomized . | 1 |
| 46 | 55 | infection seizures postoperative changes or other treatment effects r n note clinical deterioration alone is not attributable to concurrent medication or comorbid conditions is sufficient to declare | 1 | within 6 months | 1 | the last therapy . | 1 |
| 47 | 56 | patients must have at least one of the following r n recurrent / progressive disease at any time prior to enrollment regardless of response to frontline therapy r n refractory disease persistent sites of disease after less than a partial response to frontline therapy following a minimum of 4 cycles of induction therapy and patient has never had a relapse / | 1 | or regrowth as defined by the rano criteria . a minimum | 1 | the tumor during or after completion of first line systemic anti cancer therapy | 1 |
| 48 | 57 | patients who are initially rendered ned or have mrd following standard therapy but exhibit disease | 1 | at the treated site after completion | 1 | the radiation field beyond the high dose region or 80 isodose line or if there is unequivocal evidence of viable tumor on histopathologic sampling e . g . solid tumor areas i . e > = 70 tumor cell nuclei in areas high or progressive increase in mib 1 proliferation index compared with prior biopsy | 1 |
| 49 | 60 | first recurrence after concurrent or adjuvant chemoradiotherapy . imaging confirmation of first tumor | 1 | patients deemed to have progressive disease based on clinical deterioration after chemoradiation or radiographic progression outside | 1 | differentiating true progression from pseudoprogression clinical decline alone in the absence of radiographic or histologic confirmation of progression will not be sufficient for definition of progressive disease in the first 12 weeks after completion of concurrent chemoradiotherapy . for stage 1 post chemoradiation group only | 1 |
| 50 | 61 | measurable disease as defined per recist v . 1 . 1 . tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measureable if disease | 1 | prior to completion | 1 | study treatment i . e . maximum of 24 weeks from documentation of progression until study entry . disease must show evidence of radiological disease progression based on scans performed not more than 12 months apart . | 1 |
| 51 | 64 | patients who have disease | 1 | by response evaluation criteria in solid tumors recist 1 . 1 criteria within 3 months prior to study enrollment if the patient was receiving a prior line | 1 | criteria r n new enhancement outside of the radiation field beyond the high dose region or 80 isodose line r n if there is unequivocal evidence of viable tumor on histopathologic sampling e . g . | 1 |
| 52 | 65 | have evidence of disease | 1 | while on arm 1 | 1 | differentiating true progression from pseudoprogression | 1 |
| 53 | 66 | relapsed or refractory disease . relapse is defined as | 1 | by mri scan following radiation therapy or following the most recent anti tumor therapy note patients who have had surgical treatment at recurrence are eligible if they had a resection with measurable residual disease on postoperative imaging or if there is imaging evidence | 1 | progressive disease in the first 12 weeks after completion of concurrent chemoradiotherapy r n for patients with who grade iii or iv glioma and progressive disease > = 12 weeks after completion of chemoradiotherapy progression can be defined by the following set of criteria r n new contrast enhancing lesion outside of radiation field on decreasing | 1 |
| 54 | 67 | patients must have documented disease | 1 | within 60 days | 1 | the following r n development of new lesions or increase of enhancement radiological evidence of malignant transformation r n a 25 increase of the t2 or flair non enhancing lesion on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy | 1 |
| 55 | 68 | subjects must have completed or had disease | 1 | after a platinum based chemotherapy in patients for whom administration | 1 | 4 cycles of induction therapy and patient has never had a relapse / progression | 1 |
| 56 | 70 | evidence of tumor | 1 | on or within 60 days | 1 | vaccination | 1 |
| 57 | 75 | subject has disease | 1 | by at least one | 1 | completion of curatively intended systemic treatment for locoregionally advanced hnscc . | 1 |
| 58 | 76 | may have previously received lapatinib as part of a regimen in the perioperative or metastatic setting with evidence of | 1 | on the post treatment scan or rising ca 125 level following completion | 1 | systemic disease at screening | 1 |
| 59 | 77 | for the dose finding phase patients may have stable disease or | 1 | at the end | 1 | 12 weeks must have elapsed from the completion of radiotherapy to study entry to minimize the potential for mri changes related to radiation necrosis that might be misdiagnosed as progression of disease unless there is a new lesion outside the radiation field or unequivocal evidence of viable tumor on histopathological sampling . | 1 |
| 60 | 78 | patients must have in the opinion of the investigator clinical complete response or partial response and have no clinical evidence of disease | 1 | . recist progression will determine progressive disease regardless | 1 | therapy is clearly documented . | 1 |
| 61 | 79 | stable disease or progressive disease on the post treatment scan or clinical evidence of | 1 | and date | 1 | the radiation field are not eligible patients deemed to have pseudoprogression are eligible | 1 |
| 62 | 80 | anatomic imaging ct or mri of all sites of disease along with chest ct at baseline and restaging for all patients will be done to allow for assessment of recist | 1 | and absence | 1 | disease after last therapy demonstrated by rano criteria | 1 |
| 63 | 81 | patient must have documented disease | 1 | rather than true disease progression patients must not have received any form | 1 | intended frontline therapy including patients demonstrating disease progression after interval cytoreduction | 1 |
| 64 | 82 | patients with other systemic illness or have not recovered adequately from their primary treatment or who have evidence of | 1 | on enzalutamide defined by 1 or more | 1 | systemic therapy he / she shomcLd have evidence of disease progression on that line of treatment prior to enrollment | 1 |
| 65 | 83 | gynecologic cancer intergroup gcig defined ca125 | 1 | 24 months from start | 1 | disease after an initial response to previous treatment more than 60 days after cessation of treatment . refractory disease is defined as less than < 25 percent reduction in m protein or progression of disease during treatment or within 60 days after cessation of treatment | 1 |
| 66 | 84 | participants must have met all criteria to be enrolled on the main protocol for receipt of neratinib at the time of enrollment on the extension phase for cohorts 1 and 3 patients must have experienced | 1 | a patient must not have evidence | 1 | this protocol the follow up tumor assessment form documenting disease progression must be submitted to southwestern oncology group swog prior to step 3 crossover registration | 1 |
| 67 | 85 | clinical | 1 | during 6 month period prior to the time | 1 | disease appropriate therapy or not be candidates for therapy of proven efficacy for their disease | 1 |
| 68 | 86 | require radiation therapy for palliation of symptoms or to prevent local | 1 | since such therapy if it was within 6 months sites that have received ebrt must have disease progression post ebrt to be used as sites | 1 | disease progression as compared to the first postoperative scan | 1 |
| 69 | 87 | in order to prevent registering patients with pseudo | 1 | following discontinuation | 1 | discontinuation from most recent therapy | 1 |
| 70 | 88 | no evidence of relapse or | 1 | including history and increasing physical symptoms will also be eligible on study documentation will include a physician s rationale that supports evidence | 1 | taxanes and anthracyclines is not planned . progression must fmcLfill one of the following criteria | 1 |
| 71 | 89 | cohort 1 and acinic cell carcinoma patients in cohort 2 only patients must have documentation of a new or progressive lesion on a radiologic imaging study performed within 6 months prior to study enrollment | 1 | . there is no upper limit on the number | 1 | completion of the last therapy | 1 |
| 72 | 90 | evidence of relapse or | 1 | prior to the date registration and more than three months after completion | 1 | the following | 1 |
| 73 | 91 | having documented disease | 1 | during therapy or progression on or within 60 days after completion | 1 | disease washout period for lapatinib of 14 days | 1 |
| 74 | 92 | no response or disease | 1 | after receiving at least 4 weeks | 1 | disease on the most recent treatment for the expansion phase patients must also have stable disease or progression of disease on the most recent treatment progression of disease is defined as new or worsening disease on objective imaging progression or disease includes recurrence diagnosed while on adjuvant letrozole or exemestane | 1 |
| 75 | 94 | subjects with a history of prior radiotherapy are eligible if they meet the following parameters prior to study treatment administration must be 21 days post therapy and have recovered from all toxicities must have evidence of measurable disease outside the radiation fields or radiologically confirmed | 1 | by pcwg2 criteria in the absence | 1 | this chemotherapy course . patients with stable disease on the post treatment scan at completion of first line platinum containing therapy are not eligible for the study . | 1 |
| 76 | 97 | histologically or cytologically confirmed high grade metastatic sarcoma that has been stable on 6 12 cycles of one chemotherapeutic regimen cytotoxic or biologic although a change in chemotherapy is allowed if it is a resmcLt of toxicity / tolerability rather than | 1 | within 6 months prior to start | 1 | the patient s first line chemotherapy treatment . | 1 |
| 77 | 98 | experienced no | 1 | during or immediately after last therapy according to any | 1 | other imaging . | 1 |
| 78 | 99 | patients must have evidence of | 1 | during or within 12 months | 1 | last documented disease progression must be within 12 months from date of randomization | 1 |
| 79 | 100 | documented evidence of disease | 1 | or recurrence or failure to achieve complete response with standard therapy or < 20 chance | 1 | their current cancer prior to therapy that in the investigator s opinion womcLd preclude their inclusion | 1 |
| 80 | 101 | prior radioactive iodine must have been completed at least 6 months prior to registration or there must be documented disease | 1 | . for patients with grade iii anaplastic gliomas recurrent disease at the time | 1 | disease upon imaging or small volume asymptomatic disease upon imaging and who have progressed following one two or three lines of chemotherapy for recurrent disease | 1 |
| 81 | 102 | progressive disease defined as one or more of the following three criteria note subjects who received an antiandrogen must demonstrate disease | 1 | / recurrence | 1 | non cns disease by recist 1 . 1 criteria | 1 |
| 82 | 103 | there is | 1 | who criteria | 1 | symptoms with any radiographic progression on mri within 21 days prior to registration any progression in size or enhancement on mri along with worsening symptoms will be defined as progression prior to enrollment radiographic progression is defined as any increase in tumor size in axial or sagittal images or progressive contrast enhancement and abnormal t2 / flair signal by mri | 1 |
| 83 | 104 | patients with newly diagnosed unresectable metastatic and measurable asps who show clinical evidence of disease | 1 | by mri scan and shomcLd have failed radiation therapy . the scan done prior to study entry documenting progression will be reviewed by the treating physician to document changes in tumor dimension to confirm recurrence . patients with prior therapy that included interstitial brachytherapy or stereotactic radiosurgery must have confirmation | 1 | disease and associated complications and / or symptoms from metastases | 1 |
| 84 | 105 | all patients must have evidence of progressive disease on study entry . previously untreated patients who are not chemotherapy candidates on arm 2 may have advanced disease without clear | 1 | following initial definitive therapy s such as surgery with or without adjuvant radiation therapy and / or chemotherapy confirmed by diagnostic biopsy or contrast enhanced mri and evaluable by macdonald criteria note if first recurrence | 1 | cranial radiation within 12 weeks of study entry note patients who have received cranial radiation within 12 weeks of study entry will be allowed to register to trial only if either progressive disease is confirmed via biopsy or there is a new area of enhancement consistent with recurrent tumor outside the radiation field defined as the region outside the high dose region or 80 isodose line | 1 |
| 85 | 107 | measurable disease per the recist criteria . for disease occurring in previously irradiated field there must be confirmed | 1 | or recurrence within 6 months | 1 | underlying disease molecmcLar evidence of relapse / progression or mixed chimerism is permitted | 1 |
| 86 | 108 | patients with uncontrollable | 1 | NA | disease after transplantation | 1 | |
| 87 | 109 | mm that is refractory to the most recent treatment regimen . refractory is defined as 25 response to therapy or | 1 | NA | the following criteria | 1 | |
| 88 | 111 | and for treatment period 2 only 1 patients participating in treatment period 1 must have had disease | 1 | NA | last previous therapy | 1 | |
| 89 | 112 | dose confirmation cohort a dc a only currently receiving enzalutamide as most recent systemic therapy for mcrpc and have experienced psa | 1 | NA | disease despite androgen ablation shown by objective documented evidence of disease progression excluding psa . | 1 | |
| 90 | 113 | and proximal colon net with documented disease | 1 | NA | disease must not have had > = 25 of their functional bone marrow irradiated . must have radiologically measureable disease a life expectancy > = 12 weeks and adequate organ function . | 1 | |
| 91 | 114 | if receiving an antiandrogen as part of first line hormonal therapy must have shown | 1 | NA | disease appropriate therapy for metastatic disease or not be candidates for therapy of proven efficacy for their disease . | 1 | |
| 92 | 116 | they show evidence of disease | 1 | NA | disease appropriate therapy for metastatic disease or not be candidates for therapy of proven efficacy for their disease | 1 | |
| 93 | 117 | must have had | 1 | NA | progression at any time while on chemotherapy in order to be eligible for this trial | 1 | |
| 94 | 118 | patient has had more than one recurrence or | 1 | NA | disease per the irrc1 | 1 | |
| 95 | 120 | for tumors other than dsrct patients must have a history of tumor | 1 | NA | disease during or after last treatment | 1 | |
| 96 | 121 | for patients with grade iv gbm recurrent disease at the time of the first or second recurrence or | 1 | NA | measurable disease | 1 | |
| 97 | 122 | patient has recurrence or | 1 | NA | antiandrogen | 1 | |
| 98 | 123 | experienced | 1 | NA | disease documented by recist 1 . 1 | 1 | |
| 99 | 124 | patients who develop a recurrence or | 1 | NA | clinical disease progression i . e . | 1 | |
| 100 | 125 | patients must have shown unequivocal evidence for tumor recurrence or | 1 | NA | prior treatments provided that all inclusion criteria are met and exclusion criteria are not met . | 1 |