Malignant Neoplasms | Malignant solid tumour | Epithelial ovarian cancer | Standard therapy | Disease Progression | Therapeutic procedure Effective Lacking | Platinum Resistant | Taxane Resistant | Combined Modality Therapy failed | Exception Medical contraindication Taxane | Exception Medical contraindication Platinum | K-ras mutant Neoplasms | Pancreatic carcinoma | Non-Small Cell Lung Carcinoma | Colorectal Carcinoma | Malignant Head and Neck Neoplasm | EGFR Tyrosine Kinase Inhibitor Therapy Refractory | EGFR Tyrosine Kinase Inhibitor Therapy Resistant | Line of Chemotherapy Quantity
Item
histologic (pertaining to body tissues) or cytologic (pertaining to cells) documentation of malignancy (cancer or other progressively enlarging and spreading tumor) as follows: malignant solid tumors (cohort 1-4 only); cohorts 5 and phase 2: epithelial (tissue covering outer layers of most body organs and parts) ovarian cancers (abnormal tissue growth) that have progressed on or after standard therapy, or for which there is no effective therapy or platinum resistant and taxane resistant, defined as progression on or within 6 months of completing therapy with taxane and platinum either alone or in combination (unless contraindications for taxane or platinum exist), and for which there is no effective therapy, or participants with known kras mutant tumors or pancreatic cancer, or non-small cell lung cancer (nsclc), colorectal cancer (crc) or head and neck (h&n) cancer that are refractory or resistant to anti-epidermal growth factor receptor (egfr) therapy and all participants must have received at least 1 line of standard chemotherapy
boolean
C0006826 (UMLS CUI [1])
C1698088 (UMLS CUI [2])
C0677886 (UMLS CUI [3])
C2936643 (UMLS CUI [4])
C0242656 (UMLS CUI [5])
C0087111 (UMLS CUI [6,1])
C1280519 (UMLS CUI [6,2])
C0332268 (UMLS CUI [6,3])
C0032207 (UMLS CUI [7,1])
C0332325 (UMLS CUI [7,2])
C0215136 (UMLS CUI [8,1])
C0332325 (UMLS CUI [8,2])
C0009429 (UMLS CUI [9,1])
C0231175 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C1301624 (UMLS CUI [10,2])
C0215136 (UMLS CUI [10,3])
C1705847 (UMLS CUI [11,1])
C1301624 (UMLS CUI [11,2])
C0032207 (UMLS CUI [11,3])
C0022457 (UMLS CUI [12,1])
C0596988 (UMLS CUI [12,2])
C0027651 (UMLS CUI [12,3])
C0235974 (UMLS CUI [13])
C0007131 (UMLS CUI [14])
C0009402 (UMLS CUI [15])
C0278996 (UMLS CUI [16])
C3899317 (UMLS CUI [17,1])
C0205269 (UMLS CUI [17,2])
C3899317 (UMLS CUI [18,1])
C0332325 (UMLS CUI [18,2])
C4524693 (UMLS CUI [19,1])
C0392920 (UMLS CUI [19,2])
C1265611 (UMLS CUI [19,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status score less than or equal to 2
boolean
C1520224 (UMLS CUI [1])
Toxicity Reversible Due to Prior Therapy | Patient recovered CTCAE Grades
Item
participants must have recovered from reversible toxicity (any harmful effect of a drug or poison) of previous treatment to less than or equal to grade 1 or an acceptable baseline
boolean
C0600688 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C1514463 (UMLS CUI [1,4])
C1115804 (UMLS CUI [2,1])
C1516728 (UMLS CUI [2,2])
Childbearing Potential Pregnancy test negative
Item
women of child bearing potential must have a negative pregnancy test at screening
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Evaluable Disease | Measurable Disease
Item
cohort 5 and phase 2 cohorts must have evaluable or measurable disease (defined by response evaluation criteria in solid tumors [recist], as applicable)
boolean
C1516986 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Systemic therapy Malignant Neoplasms | Major surgery Malignant Neoplasms | Nitrosoureas | Mitomycin | Status pre- Siltuximab Administration
Item
received any prior systemic therapy or had major surgery for the cancer under study within 4 weeks (in the case of nitrosoureas and mitomycin c within 6 weeks) prior to first siltuximab administration
boolean
C1515119 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0679637 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0028210 (UMLS CUI [3])
C0002475 (UMLS CUI [4])
C0332152 (UMLS CUI [5,1])
C1609931 (UMLS CUI [5,2])
C1533734 (UMLS CUI [5,3])
IL-6 Targeted Therapy
Item
prior anti-interleukin 6 (il-6) targeted therapy
boolean
C0021760 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
Comorbidity Serious | Heart Disease Uncontrolled | Angina, Unstable | Chest Pain Due to SERUM OXYGEN DECREASED | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia | Abnormal cardiac conduction
Item
serious concurrent illness or history of uncontrolled heart disease such as: unstable angina (chest pain due to decreased oxygen being supplied to the heart), congestive heart failure (failure of the heart resulting in fluid build-up in the lungs, other body tissues, or both), myocardial infarction (heart attack) within preceding 12 months, clinically significant rhythm or conduction abnormality
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0002965 (UMLS CUI [3])
C0008031 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0242091 (UMLS CUI [4,3])
C0018802 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
C0003811 (UMLS CUI [7])
C0232219 (UMLS CUI [8])
Hypersensitivity Murine protein | Hypersensitivity Fusion protein | Protein allergy
Item
participants with known allergies (over sensitivity to a substance) or clinically significant reactions to murine, chimeric, or human proteins
boolean
C0020517 (UMLS CUI [1,1])
C1699668 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0162768 (UMLS CUI [2,2])
C1112677 (UMLS CUI [3])
Medical condition Uncontrolled | Laboratory test result abnormal | Study Subject Participation Status At risk | Interference Interpretation Research data
Item
any uncontrolled medical condition, including the presence of laboratory abnormalities, that places the participant at unacceptable risk by participating in the study or confounds the ability to interpret data from the study
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0438215 (UMLS CUI [2])
C2348568 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0521102 (UMLS CUI [4,1])
C0459471 (UMLS CUI [4,2])
C0681873 (UMLS CUI [4,3])