ID

31336

Descripción

A Safety, Efficacy and Pharmacokinetic Study of Siltuximab (CNTO 328) in Participants With Solid Tumors; ODM derived from: https://clinicaltrials.gov/show/NCT00841191

Link

https://clinicaltrials.gov/show/NCT00841191

Palabras clave

Versiones (1)
  1. 15/8/18 15/8/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

15 de agosto de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Ovarian Neoplasms NCT00841191

Inglés

Eligibility Ovarian Neoplasms NCT00841191

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
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
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C1698088
UMLS CUI [3]
C0677886
UMLS CUI [4]
C2936643
UMLS CUI [5]
C0242656
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C1280519
UMLS CUI [6,3]
C0332268
UMLS CUI [7,1]
C0032207
UMLS CUI [7,2]
C0332325
UMLS CUI [8,1]
C0215136
UMLS CUI [8,2]
C0332325
UMLS CUI [9,1]
C0009429
UMLS CUI [9,2]
C0231175
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C1301624
UMLS CUI [10,3]
C0215136
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C1301624
UMLS CUI [11,3]
C0032207
UMLS CUI [12,1]
C0022457
UMLS CUI [12,2]
C0596988
UMLS CUI [12,3]
C0027651
UMLS CUI [13]
C0235974
UMLS CUI [14]
C0007131
UMLS CUI [15]
C0009402
UMLS CUI [16]
C0278996
UMLS CUI [17,1]
C3899317
UMLS CUI [17,2]
C0205269
UMLS CUI [18,1]
C3899317
UMLS CUI [18,2]
C0332325
UMLS CUI [19,1]
C4524693
UMLS CUI [19,2]
C0392920
UMLS CUI [19,3]
C1265611
eastern cooperative oncology group (ecog) performance status score less than or equal to 2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
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
Descripción

Toxicity Reversible Due to Prior Therapy | Patient recovered CTCAE Grades

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C1514463
UMLS CUI [2,1]
C1115804
UMLS CUI [2,2]
C1516728
women of child bearing potential must have a negative pregnancy test at screening
Descripción

Childbearing Potential Pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
cohort 5 and phase 2 cohorts must have evaluable or measurable disease (defined by response evaluation criteria in solid tumors [recist], as applicable)
Descripción

Evaluable Disease | Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516986
UMLS CUI [2]
C1513041
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
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
Descripción

Systemic therapy Malignant Neoplasms | Major surgery Malignant Neoplasms | Nitrosoureas | Mitomycin | Status pre- Siltuximab Administration

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0006826
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C0006826
UMLS CUI [3]
C0028210
UMLS CUI [4]
C0002475
UMLS CUI [5,1]
C0332152
UMLS CUI [5,2]
C1609931
UMLS CUI [5,3]
C1533734
prior anti-interleukin 6 (il-6) targeted therapy
Descripción

IL-6 Targeted Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0021760
UMLS CUI [1,2]
C2985566
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
Descripción

Comorbidity Serious | Heart Disease Uncontrolled | Angina, Unstable | Chest Pain Due to SERUM OXYGEN DECREASED | Congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia | Abnormal cardiac conduction

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0002965
UMLS CUI [4,1]
C0008031
UMLS CUI [4,2]
C0678226
UMLS CUI [4,3]
C0242091
UMLS CUI [5]
C0018802
UMLS CUI [6]
C0027051
UMLS CUI [7]
C0003811
UMLS CUI [8]
C0232219
participants with known allergies (over sensitivity to a substance) or clinically significant reactions to murine, chimeric, or human proteins
Descripción

Hypersensitivity Murine protein | Hypersensitivity Fusion protein | Protein allergy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1699668
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0162768
UMLS CUI [3]
C1112677
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
Descripción

Medical condition Uncontrolled | Laboratory test result abnormal | Study Subject Participation Status At risk | Interference Interpretation Research data

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0438215
UMLS CUI [3,1]
C2348568
UMLS CUI [3,2]
C1444641
UMLS CUI [4,1]
C0521102
UMLS CUI [4,2]
C0459471
UMLS CUI [4,3]
C0681873
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Similar models

Eligibility Ovarian Neoplasms NCT00841191

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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