Pleural mesothelioma malignant advanced | Peritoneal Mesothelioma Advanced | Non-squamous non-small cell lung cancer TNM clinical staging | Prior Chemotherapy Absent | Prior Immunotherapy Absent | Uveal melanoma metastatic | Liver carcinoma | Sorafenib failed | Disease Progression Radiography | Status Cirrhotic Child-Pugh Classification | Anticoagulant therapy | INR Status | Glioma Severe | Temozolomide failed
Item
1. histologically proven advanced mpm, advanced peritoneal mesothelioma (for dose escalation cohort only) or non-squamous nsclc (stage iiib/iv) who have not been treated with prior chemotherapy or immunotherapy, except that nsclc subjects with egfr mutant or alk positive must have had an egfr tyrosine kinase inhibitor (tki) or alk inhibitor and progressed or been shown to be intolerant of therapy prior to enrolling in this trial, if such alk inhibitor and egfr targeted therapy are approved and available in the country in which patients are being enrolled or histologically proven metastatic uveal melanoma who have not been treated with prior chemotherapy (mtd cohort only), or histologically proven hcc who have failed (pd and/or side effects-been intolerant of) treatment with sorafenib. failure is defined as having progressed radiographically on, or been intolerant to prior systemic therapy. intolerance is defined as discontinuation due to an ae(s) on prior systemic therapy that was unacceptable to the treating physician and / or patient, with or without dose interruption and modification. failure requires at least 14 days of treatment with sorafenib, except for a subject that has had a severe allergic reaction to sorafenib at any time, even less than 14 days of treatment with sorafenib and thus it would be imprudent to re-challenge them with that agent. cirrhotic status of child-pugh grade a-b7 must be present. child-pugh status should be determined based on clinical findings and laboratory data during the screening period (appendix e). subjects on anti-coagulants are to receive 1 point for their inr status, as they are presumed to have a <1.7 baseline pt/inr.", or histologically proven high-grade glioma who have failed (pd and/or side effects) treatment with radiotherapy ± temozolomide.
boolean
C0854889 (UMLS CUI [1])
C1377610 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C4324656 (UMLS CUI [3,1])
C3258246 (UMLS CUI [3,2])
C1514457 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1514461 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0220633 (UMLS CUI [6,1])
C1522484 (UMLS CUI [6,2])
C2239176 (UMLS CUI [7])
C1516119 (UMLS CUI [8,1])
C0231175 (UMLS CUI [8,2])
C0242656 (UMLS CUI [9,1])
C0034571 (UMLS CUI [9,2])
C0449438 (UMLS CUI [10,1])
C0439686 (UMLS CUI [10,2])
C2347612 (UMLS CUI [10,3])
C0150457 (UMLS CUI [11])
C0525032 (UMLS CUI [12,1])
C0449438 (UMLS CUI [12,2])
C0017638 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
C0076080 (UMLS CUI [14,1])
C0231175 (UMLS CUI [14,2])
ASS1 Deficiency Tissue specimen Immunohistochemistry
Item
2. ass1 deficiency (defined as ≤50% ass expression) demonstrated on tissue specimen (cytospin samples are acceptable) by immunohistochemistry (ihc). for subjects previously treated with chemotherapy, this specimen may have been obtained before that chemotherapy. a new tissue specimen obtained after most recent chemotherapy is not required. thus ass1 deficiency is required for entrance into the study. if tissue is not available to determine ass1 deficiency, then tissue must be obtained by biopsy to determine ass1 status.
boolean
C4527366 (UMLS CUI [1,1])
C1292533 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
Measurable Disease
Item
3. measurable disease as assessed by modified recist for mpm and by recist 1.1 criteria for peritoneal mesothelioma, nsclc, uveal melanoma, hcc and glioma (appendices a and b).
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status of 0 - 1 (appendix c).
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
5. predicted life expectancy of at least 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Therapeutic radiology procedure | Exception Intent Palliative | Targeted Therapy | Immunotherapy | Exception Immunotherapy Uveal melanoma
Item
1. radiotherapy (except for palliative reasons), targeted therapy, or immunotherapy (except for uveal melanoma) the previous four weeks before study treatment.
boolean
C1522449 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1283828 (UMLS CUI [2,2])
C1285530 (UMLS CUI [2,3])
C2985566 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0021083 (UMLS CUI [5,2])
C0220633 (UMLS CUI [5,3])
Manifestations Toxic Due to Prior Therapy
Item
2. ongoing toxic manifestations of previous treatments.
boolean
C1280464 (UMLS CUI [1,1])
C1407029 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,4])
Metastatic malignant neoplasm to brain Symptomatic | Secondary malignant neoplasm of spinal cord Symptomatic | Patient's condition stable Post Therapeutic radiology procedure | Patient's condition stable Post Operative Surgical Procedures
Item
3. symptomatic brain or spinal cord metastases (patients must be stable for > 3 months post radiotherapy or surgery) for subjects with mesothelioma, nsclc, uveal melanoma excludes subjects with hcc or glioma).
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0347016 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C1282982 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
C1282982 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C0543467 (UMLS CUI [4,3])
Thoracic Surgical Procedure Major | Operation on abdominal region Major | Recovery Lacking
Item
4. major thoracic or abdominal surgery from which the patient has not yet recovered.
boolean
C0524832 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0198482 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C2004454 (UMLS CUI [3,1])
C0332268 (UMLS CUI [3,2])
Communicable Disease Serious | Requirement Antibiotics Intravenous | Communicable Disease Requirement Intravenous therapy
Item
5. serious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior to the first dose of study treatment.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0003232 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
C0009450 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0455142 (UMLS CUI [3,3])