Downloads: 1
| # | Blank 1 | Frequency | Blank 2 | Frequency | Blank 3 | Frequency | |
|---|---|---|---|---|---|---|---|
| 1 | 2 | 12 | 39 | 4 | |||
| 2 | 4 | cll arms | 2 | 2 | 1 | and arm b | 3 |
| 3 | 1 | recurrent glioma where injection in either | 1 | 1 but has | 1 | only | 2 |
| 4 | 3 | if a patient fmcLly meets criteria for | 1 | arm | 1 | and arm f | 2 |
| 5 | 7 | patients with a known hypersensitivity to tacrolimus methotrexate | 1 | or at | 1 | or b of the biologic agent womcLd require access and / or considerable spillage into the ventricmcLar system | 1 |
| 6 | 8 | surgical | 1 | 1 and arm 2 r n patients in arm 1 single agent rucaparib followed by combination upon progression must be parpi naive prior irinotecan is allowed r n patients in arm 2 combination must have been treated with and progressed on | 1 | anc > = 1500 / mcL | 1 |
| 7 | 9 | actively receiving ibrutinib at either 420 mg patients enrolled to the escalation | 1 | b cohort 3 patients must not have | 1 | history of solid organ or bone marrow transplant the patient will be eligible for arm 2 | 1 |
| 8 | 10 | parpi naive or prior exposure to parpi therapy varies depending on | 1 | 2 subjects must have received at least one prior therapy and | 1 | and arm c for combination therapy including ibrutinib or idelalisib | 1 |
| 9 | 11 | according to the sequence | 1 | arm b 30 33 fractions may receive concurrent chemotherapy with carboplatin / taxol at their treating physician s discretion patients enrolled to the experimental arm arm | 1 | and arm c for combination therapy including idelalisib arm | 1 |
| 10 | 12 | prior pemetrexed is allowed except | 1 | but are eligible for participation in other study arm patients that have | 1 | or c exclusion | 1 |
| 11 | 13 | must have started adt for metastatic disease within 134 days for | 1 | 2 patients must express hla | 1 | or c or mmf arm b or d | 1 |
| 12 | 14 | phase ia part advanced solid tumors or metastases including lymphoma localized in the head and neck region or thorax with an indication for fractionated palliative rt | 1 | r n for arm | 1 | must be predicted pre operatively to have sufficiently sized tumor to be resected and provide tissue samples for exploratory assessments . | 1 |
| 13 | 16 | for both | 1 | c patients with | 1 | stable dose for at least 2 months prior to starting study treatment patients enrolled to the expansion arm | 1 |
| 14 | 18 | carcinoma patients in | 1 | patients previously treated with | 1 | parpi previously prior irinotecan is allowed | 1 |
| 15 | 19 | subjects in | 1 | patients be on | 1 | > = arm b > = arm c > = arm d r n exposure to biologic therapy immunotherapy chemotherapy | 1 |
| 16 | 20 | history of liver cirrhosis by radiologic clinical or laboratory data or biopsy despite normal liver function tests phase ii expansion | 1 | 1 of this study cannot re enroll onto arm 1 after being removed from this study but if they were removed from arm 1 for disease progression they are eligible to re register onto this study in order to enroll onto arm 2 of this study if they otherwise meet all of the eligibility criteria for this study all participants who received an investigational product on | 1 | dose level 4 cisplatin 75 mg / m 2 | 1 |
| 17 | 25 | phase i study | 1 | 1 evidence of recurrent or progressive supratentorial tumor which has shown | 1 | and b or within 30 days for arm c | 1 |
| 18 | 26 | must be either initiating therapy with romidepsin | 1 | iii only patients must have identifiable metastatic disease on at least 1 clinically indicated imaging modality if only soft tissue metastasis one lesion must measure at least 6 mm or greater patients must have confirmation of prostate cancer prior to 18f dcfbc imaging r n note | 1 | or treatment naïve scchn eligible for fractionated curatively intended rt with concurrent cisplatin arm b | 1 |
| 19 | 27 | while patients randomized to the standard | 1 | 2 patients previously diagnosed with | 1 | central lesion with radiologic evidence of arterial involvement | 1 |
| 20 | 28 | eligibility for crossover registration from | 1 | NA | maximum of three prior therapies . no prior treatment with 5 azacitidine is allowed in this arm . | 1 | |
| 21 | 29 | patients must show failure to achieve mer major erythroid response or have achieved mer but relapsed on | 1 | NA | or arm b must have received at least 1 prior regimen of standard of care systemic antitumor therapy for their metastatic disease and experienced tumor progression within 3 months after the last prior administration of the therapy or experienced unacceptable toxicity to these treatments . | 1 | |
| 22 | 30 | patients with known hypersensitivity to any of the components of an investigational treatment will be excluded from participation in the corresponding | 1 | NA | and arm b shomcLd have measurable ct evidence of liver metastases or liver lesions that are not treatable by surgical resection or local ablation in consmcLtation with hepatobiliary specialist . | 1 | |
| 23 | 31 | eligibility for treatment on | 1 | NA | willingness to provide all biological specimens as required by the protocol | 1 | |
| 24 | 32 | crizotinib plus pazopanib | 1 | NA | uncontrolled infection | 1 | |
| 25 | 33 | expansion cohort only for arms containing crizotinib | 1 | NA | any corticosteroid use = < 28 days prior to registration | 1 | |
| 26 | 34 | patients who have been previously treated with an anti vegf agent will be excluded from | 1 | NA | any radioembolization or transarterial chemoembolization tace = < 84 days prior to registration | 1 | |
| 27 | 36 | progression following at least 6 weeks of standard doses of herceptin | 1 | NA | dose level 1 and arm b dose level 2 | 1 | |
| 28 | 37 | pre registration chemotherapy given within 42 days of treatment treatment meaning surgery if | 1 | NA | or currently receiving romidepsin with documented stable disease sd or partial response pr arm b | 1 | |
| 29 | 38 | karnofsky / lansky performance scale r n | 1 | NA | lenalidomide alone to arm b lenalidomide and epoetin alfa | 1 | |
| 30 | 39 | renal function r n | 1 | NA | history of hypersensitivity to rapamycin derivatives will be excluded from participation in the everolimus arm | 1 | |
| 31 | 40 | hepatic function r n | 1 | NA | 0201 | 1 | |
| 32 | 41 | cardiac function r n | 1 | NA | crizotinib plus pazopanib and arm b crizotinib plus pemetrexed and arm d crizotinib plus pazopanib plus pemetrexed but not arm c pazopanib plus pemetrexed patients must have anaplastic lymphoma receptor tyrosine kinase alk abnormality including translocation alk amplification mutation and overexpression as determined by fluorescence in situ hybridization fish | 1 | |
| 33 | 42 | pmcLmonary function r n | 1 | NA | chemotherapy if arm b | 1 | |
| 34 | 43 | patient must have at least 2 measurable lesions that are > = 1 . 5 cm in one dimension one of the lesions must meet additional criteria a or b depending on the treatment | 1 | NA | > = 60 r n arm b no limitation | 1 | |
| 35 | 44 | chemotherapy radiotherapy investigational anticancer therapy or major surgery within 28 days of day 1 dosing with the following exceptions a . | 1 | NA | creatinine clearance > = 60 ml / min r n arm b no limitation | 1 | |
| 36 | 45 | part i histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy or for which no standard therapy exist . part ii | 1 | NA | r n liver enzymes < x 3 upper limit of normal mcLn r n bilirubin < x 2 mcLn and stable in the 30 days prior to tcd boost r n arm b no limitation | 1 | |
| 37 | 46 | eastern cooperative oncology group ecog performance status of 0 1 for | 1 | NA | no evidence of uncontrolled heart failure or active angina r n arm b no limitation | 1 | |
| 38 | 47 | stage i | 1 | NA | spontaneous breathing not requiring ventilatory support r n arm b no limitation | 1 | |
| 39 | 48 | ready to use reliable contraceptive procedures inclusion criteria specific to hcc | 1 | NA | patient must have at least one lesion that is > = 2 . 0 cm and is amenable to image guided cryoablation and mmcLtiple vaccine injections as determined by interventional radiology including tumors that can be safely accessed using imaging guidance and treated with minimal risk to adjacent structures r n for arm b patient must have one lesion that can be excised for in vitro vaccine preparation | 1 | |
| 40 | 49 | active hepatitis b chronic or acute or hepatitis c exception for participants in | 1 | NA | a minimum 5 day washout after discontinuation of ibrutinib therapy or other btk inhibitors is required only those subjects without rapid disease progression during the 5 day washout will be allowed to enroll into arm a . i . rapid disease progression is defined as follows | 1 | |
| 41 | 51 | g monotherapy | 1 | NA | have head and neck cancer or k ras wild type egfr expressing colon cancer arm b have non small cell lung cancer | 1 | |
| 42 | 52 | h combination | 1 | NA | and c subjects and 0 2 for arm b . | 1 | |
| 43 | 53 | participants who have previously enrolled and received study drugs on | 1 | NA | pregnancy lactation or intention to become pregnant or fathering a child during the study | 1 | |
| 44 | 55 | at least 2 doses of fusion vaccine were produced | 1 | NA | methotrexate allergy are excluded | 1 | |
| 45 | 57 | study | 1 | NA | jak inhibitor and be intolerant resistant refractory or lost response to the jak inhibitor | 1 | |
| 46 | 5 | NA | NA | stable dose of ruxolitinib | 1 | ||
| 47 | 6 | NA | NA | clinical trial | 1 | ||
| 48 | 15 | NA | NA | > = 25 increase in bi dimensional measurements by mri or is refractory with significant neuro deterioration that is not otherwise explained with no known curative therapy . arm 2 clinical presentation of dipg and compatible mri with approximately 2 / 3 of the pons included . subject shomcLd be 2 weeks and 10 weeks post standard focal radiotherapy ie dose of 5400 to 5960 cgy and maximum dexamethasone of 1 mg / m2 / day | 1 | ||
| 49 | 17 | NA | NA | patient who is eligible for one arm subsequently may cross over into a different arm | 1 | ||
| 50 | 21 | NA | NA | non mucinous epithelial ovarian carcinoma including serous clear cell and endometrioid histologies as well as borderline ovarian tumors currently undergoing routine surveillance for recurrence | 1 |