ID

36633

Beskrivning

Study of INCB039110 in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02257619

Länk

https://clinicaltrials.gov/show/NCT02257619

Nyckelord

Versioner (1)
  1. 2019-05-27 2019-05-27 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

27 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Non-Small Cell Lung Cancer NCT02257619

Engelsk

Eligibility Non-Small Cell Lung Cancer NCT02257619

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed diagnosis of nsclc that is stage iiib, iv, or recurrent.
Beskrivning

Non-Small Cell Lung Carcinoma TNM clinical staging | Non-small cell lung cancer recurrent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0278517
2. received only 1 prior systemic chemotherapy regimen for stage iiib, iv, or recurrent disease not including neoadjuvant and/or adjuvant therapy. (note: exceptions may be allowed based on prior treatment regimens and tumor types in agreement with protocol requirements.)
Beskrivning

Systemic Chemotherapy Quantity Non-Small Cell Lung Carcinoma TNM clinical staging | Systemic Chemotherapy Quantity Non-small cell lung cancer recurrent | Neoadjuvant Therapy Absent | Adjuvant therapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1883256
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0007131
UMLS CUI [1,4]
C3258246
UMLS CUI [2,1]
C1883256
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0278517
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0677850
UMLS CUI [4,2]
C0332197
3. eastern cooperative oncology group (ecog) performance status 0 to 2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
4. life expectancy of ≥12 weeks.
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. received prior treatment with docetaxel.
Beskrivning

docetaxel

Datatyp

boolean

Alias
UMLS CUI [1]
C0246415
2. known active central nervous system (cns) metastases. subjects with cns metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to study entry, defined as:
Beskrivning

CNS metastases | Eligibility Treatment completed CNS metastases | Eligibility Clinical status Stable

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0580352
UMLS CUI [2,3]
C0686377
UMLS CUI [3,1]
C1548635
UMLS CUI [3,2]
C0449440
UMLS CUI [3,3]
C0205360
1. no evidence of new or enlarging cns metastasis or new neurological symptoms attributable to cns metastases.
Beskrivning

Eligibility Absence CNS metastases | Eligibility Absence Neurologic Symptoms CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0686377
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0235031
UMLS CUI [2,4]
C0686377
2. subjects who are receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 4 weeks prior to first dose of study treatment and off all anticonvulsants for at least 4 weeks prior to study entry.
Beskrivning

Adrenal Cortex Hormones Dose Stable | Adrenal Cortex Hormones Dose Decreasing | Anticonvulsants Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0442797
UMLS CUI [3,1]
C0003286
UMLS CUI [3,2]
C0332197
3. peripheral neuropathy ≥ grade 3.
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
4. current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.
Beskrivning

Cancer Other | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured | Exception Superficial carcinoma of urinary bladder | Exception Prostatic Intraepithelial Neoplasias | Exception Carcinoma in situ of uterine cervix | Exception Cancer Other Noninvasive

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1880198
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1336527
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0282612
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0851140
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1707251
UMLS CUI [7,3]
C2986496
5. significant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
Beskrivning

Comorbidity Uncontrolled | Kidney Diseases | Liver diseases | Hematological Disease | Gastrointestinal Diseases | Endocrine System Diseases | Lung diseases | Heart Diseases | Nervous system disorder | Cerebral disorder | Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0014130
UMLS CUI [7]
C0024115
UMLS CUI [8]
C0018799
UMLS CUI [9]
C0027765
UMLS CUI [10]
C0234387
UMLS CUI [11]
C0004936
6. unwilling to be transfused with blood components.
Beskrivning

Blood Component Transfusion Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085430
UMLS CUI [1,2]
C0558080
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT02257619

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma TNM clinical staging | Non-small cell lung cancer recurrent
Item
1. histologically or cytologically confirmed diagnosis of nsclc that is stage iiib, iv, or recurrent.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0278517 (UMLS CUI [2])
Systemic Chemotherapy Quantity Non-Small Cell Lung Carcinoma TNM clinical staging | Systemic Chemotherapy Quantity Non-small cell lung cancer recurrent | Neoadjuvant Therapy Absent | Adjuvant therapy Absent
Item
2. received only 1 prior systemic chemotherapy regimen for stage iiib, iv, or recurrent disease not including neoadjuvant and/or adjuvant therapy. (note: exceptions may be allowed based on prior treatment regimens and tumor types in agreement with protocol requirements.)
boolean
C1883256 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0007131 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C1883256 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0278517 (UMLS CUI [2,3])
C0600558 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0677850 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
ECOG performance status
Item
3. eastern cooperative oncology group (ecog) performance status 0 to 2.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
4. life expectancy of ≥12 weeks.
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
docetaxel
Item
1. received prior treatment with docetaxel.
boolean
C0246415 (UMLS CUI [1])
CNS metastases | Eligibility Treatment completed CNS metastases | Eligibility Clinical status Stable
Item
2. known active central nervous system (cns) metastases. subjects with cns metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to study entry, defined as:
boolean
C0686377 (UMLS CUI [1])
C1548635 (UMLS CUI [2,1])
C0580352 (UMLS CUI [2,2])
C0686377 (UMLS CUI [2,3])
C1548635 (UMLS CUI [3,1])
C0449440 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Eligibility Absence CNS metastases | Eligibility Absence Neurologic Symptoms CNS metastases
Item
1. no evidence of new or enlarging cns metastasis or new neurological symptoms attributable to cns metastases.
boolean
C1548635 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0686377 (UMLS CUI [1,3])
C1548635 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0235031 (UMLS CUI [2,3])
C0686377 (UMLS CUI [2,4])
Adrenal Cortex Hormones Dose Stable | Adrenal Cortex Hormones Dose Decreasing | Anticonvulsants Absent
Item
2. subjects who are receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 4 weeks prior to first dose of study treatment and off all anticonvulsants for at least 4 weeks prior to study entry.
boolean
C0001617 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0001617 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0442797 (UMLS CUI [2,3])
C0003286 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Peripheral Neuropathy CTCAE Grades
Item
3. peripheral neuropathy ≥ grade 3.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Cancer Other | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured | Exception Superficial carcinoma of urinary bladder | Exception Prostatic Intraepithelial Neoplasias | Exception Carcinoma in situ of uterine cervix | Exception Cancer Other Noninvasive
Item
4. current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1336527 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0282612 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0851140 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C1707251 (UMLS CUI [7,2])
C2986496 (UMLS CUI [7,3])
Comorbidity Uncontrolled | Kidney Diseases | Liver diseases | Hematological Disease | Gastrointestinal Diseases | Endocrine System Diseases | Lung diseases | Heart Diseases | Nervous system disorder | Cerebral disorder | Mental disorders
Item
5. significant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0024115 (UMLS CUI [7])
C0018799 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0234387 (UMLS CUI [10])
C0004936 (UMLS CUI [11])
Blood Component Transfusion Unwilling
Item
6. unwilling to be transfused with blood components.
boolean
C0085430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
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