ID

35506

Beskrivning

Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Colorectal, Non-small Cell Lung and Pancreatic Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02450656

Länk

https://clinicaltrials.gov/show/NCT02450656

Nyckelord

Versioner (1)
  1. 2019-03-06 2019-03-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasms NCT02450656

Engelsk

Eligibility Colorectal Neoplasms NCT02450656

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytological proof of advanced crc, nsclc or pancreatic cancer; for part b: treated with first line therapy for metastatic disease only.
Beskrivning

Colorectal Carcinoma Advanced | Non-Small Cell Lung Carcinoma Advanced | Pancreatic carcinoma Advanced | First line treatment Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009402
UMLS CUI [1,2]
C0205179
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C0205179
UMLS CUI [3,1]
C0235974
UMLS CUI [3,2]
C0205179
UMLS CUI [4,1]
C1708063
UMLS CUI [4,2]
C0027627
written documentation of a known pathogenic kras (exon 2, 3 or 4) mutation and pik3ca wildtype (defined as absence of mutations in exon 9 and 20)
Beskrivning

KRAS Exon 2 Mutation | KRAS Exon 3 Mutation | KRAS Exon 4 Mutation | PIK3CA gene Wild Type

Datatyp

boolean

Alias
UMLS CUI [1]
C4525999
UMLS CUI [2]
C4528684
UMLS CUI [3]
C4526000
UMLS CUI [4,1]
C1335212
UMLS CUI [4,2]
C1883559
able and willing to give written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
able and willing to undergo blood sampling for pk and pd analysis
Beskrivning

Blood sampling

Datatyp

boolean

Alias
UMLS CUI [1]
C0005834
life expectancy >=3 months allowing adequate follow up of toxicity evaluation and antitumor activity.
Beskrivning

Life Expectancy allowing Follow-up

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0683607
UMLS CUI [1,3]
C3274571
who performance status of 0 or 1.
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
able and willing to undergo a tumor biopsies prior to start, after two weeks (part a only) and upon progression of disease
Beskrivning

Tumor Biopsy | Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0005558
UMLS CUI [2]
C0242656
measurable disease according to recist 1.1
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
adequate organ system function measured by laboratory values
Beskrivning

Organ function Laboratory Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0022885
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
history of another malignancy exception part a: patients who have been disease-free for at least 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent second malignancies are eligible. exception part b: adequately treated carcinoma in situ of the cervix and adequately treated basal cell carcinoma of the skin. 3. symptomatic or untreated leptomeningeal disease.
Beskrivning

Cancer Other | Exception Disease Free Duration | Exception Skin carcinoma Resected Completely | Exception Second malignancy indolent | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Leptomeningeal Neoplasm Symptomatic | Leptomeningeal Neoplasm Untreated

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0449238
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [3,3]
C1521996
UMLS CUI [3,4]
C0205197
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0085183
UMLS CUI [4,3]
C0234227
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0851140
UMLS CUI [5,3]
C1522326
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0007117
UMLS CUI [6,3]
C1522326
UMLS CUI [7,1]
C0751297
UMLS CUI [7,2]
C0231220
UMLS CUI [8,1]
C0751297
UMLS CUI [8,2]
C0332155
symptomatic brain metastasis.
Beskrivning

Metastatic malignant neoplasm to brain Symptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
patients previously treated with any drug combination known to interfere with egfr, her2, her3, her4 or mapk- and pi3k-pathway components, including inhibitors of pten, pi3k, akt, mtor, braf, mek and erk.
Beskrivning

Combined Modality Therapy Interferes with Epidermal Growth Factor Receptor | Combined Modality Therapy Interferes with HER2 | Combined Modality Therapy Interferes with HER3 | Combined Modality Therapy Interferes with HER4 | Combined Modality Therapy Interferes with Mitogen-Activated Protein Kinases Component | Combined Modality Therapy Interferes with Phosphatidylinositol 3-Kinases Component | Combined Modality Therapy Interferes with PTEN inhibitors | Combined Modality Therapy Interferes with Phosphatidylinositol 3-Kinases inhibitors | Combined Modality Therapy Interferes with AKT1 inhibitors | Combined Modality Therapy Interferes with AKT2 inhibitors | Combined Modality Therapy Interferes with AKT3 inhibitors | Combined Modality Therapy Interferes with mTOR Inhibitor | Combined Modality Therapy Interferes with B-Raf inhibitor | Combined Modality Therapy Interferes with MEK Inhibitor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009429
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0034802
UMLS CUI [2,1]
C0009429
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0069515
UMLS CUI [3,1]
C0009429
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0072460
UMLS CUI [4,1]
C0009429
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0812267
UMLS CUI [5,1]
C0009429
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0752312
UMLS CUI [5,4]
C1705248
UMLS CUI [6,1]
C0009429
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C2936824
UMLS CUI [6,4]
C1705248
UMLS CUI [7,1]
C0009429
UMLS CUI [7,2]
C0521102
UMLS CUI [7,3]
C0694888
UMLS CUI [7,4]
C0243077
UMLS CUI [8,1]
C0009429
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C2936824
UMLS CUI [8,4]
C0243077
UMLS CUI [9,1]
C0009429
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C0812228
UMLS CUI [9,4]
C0243077
UMLS CUI [10,1]
C0009429
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C0812230
UMLS CUI [10,4]
C0243077
UMLS CUI [11,1]
C0009429
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C1332074
UMLS CUI [11,4]
C0243077
UMLS CUI [12,1]
C0009429
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C2746052
UMLS CUI [13,1]
C0009429
UMLS CUI [13,2]
C0521102
UMLS CUI [13,3]
C4521853
UMLS CUI [14,1]
C0009429
UMLS CUI [14,2]
C0521102
UMLS CUI [14,3]
C2347168
history of interstitial lung disease or pneumonitis
Beskrivning

Lung Diseases, Interstitial | Pneumonitis

Datatyp

boolean

Alias
UMLS CUI [1]
C0206062
UMLS CUI [2]
C3714636
radio-, immuno- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. palliative radiation (1x 8gy) is allowed.
Beskrivning

Therapeutic radiology procedure | Immunotherapy | Chemotherapy | Palliative Radiation Therapy allowed

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0021083
UMLS CUI [3]
C0392920
UMLS CUI [4,1]
C3898008
UMLS CUI [4,2]
C0683607
opthalmological diseases
Beskrivning

Disorder of eye

Datatyp

boolean

Alias
UMLS CUI [1]
C0015397
patients with left ventricular ejection fraction (lvef) < 55%
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
patients with cardiac comorbidities
Beskrivning

Comorbidity Cardiac

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C1522601
concomitant or recent use (in the past 14 days) of strong inhibitors and inducers of cyp1a2, cyp2c19, cyp3a4, 3a5 and p-glycoprotein (p-gp)
Beskrivning

CYP1A2 Inhibitors | CYP1A2 Inducers | CYP2C19 Inhibitors | CYP2C19 Inducers | CYP3A4 Inhibitors | CYP3A4 Inducers | CYP3A5 Inhibitors | CYP3A5 Inducers | P-Glycoprotein Inhibitors | P-Glycoprotein Inducers

Datatyp

boolean

Alias
UMLS CUI [1]
C3850068
UMLS CUI [2]
C3850050
UMLS CUI [3]
C3850059
UMLS CUI [4]
C3850047
UMLS CUI [5]
C3850053
UMLS CUI [6]
C3850041
UMLS CUI [7]
C3850054
UMLS CUI [8]
C3850043
UMLS CUI [9]
C3500483
UMLS CUI [10]
C3883353
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Similar models

Eligibility Colorectal Neoplasms NCT02450656

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Colorectal Carcinoma Advanced | Non-Small Cell Lung Carcinoma Advanced | Pancreatic carcinoma Advanced | First line treatment Neoplasm Metastasis
Item
histological or cytological proof of advanced crc, nsclc or pancreatic cancer; for part b: treated with first line therapy for metastatic disease only.
boolean
C0009402 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C0235974 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C1708063 (UMLS CUI [4,1])
C0027627 (UMLS CUI [4,2])
KRAS Exon 2 Mutation | KRAS Exon 3 Mutation | KRAS Exon 4 Mutation | PIK3CA gene Wild Type
Item
written documentation of a known pathogenic kras (exon 2, 3 or 4) mutation and pik3ca wildtype (defined as absence of mutations in exon 9 and 20)
boolean
C4525999 (UMLS CUI [1])
C4528684 (UMLS CUI [2])
C4526000 (UMLS CUI [3])
C1335212 (UMLS CUI [4,1])
C1883559 (UMLS CUI [4,2])
Informed Consent
Item
able and willing to give written informed consent
boolean
C0021430 (UMLS CUI [1])
Blood sampling
Item
able and willing to undergo blood sampling for pk and pd analysis
boolean
C0005834 (UMLS CUI [1])
Life Expectancy allowing Follow-up
Item
life expectancy >=3 months allowing adequate follow up of toxicity evaluation and antitumor activity.
boolean
C0023671 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
WHO performance status scale
Item
who performance status of 0 or 1.
boolean
C1298650 (UMLS CUI [1])
Tumor Biopsy | Disease Progression
Item
able and willing to undergo a tumor biopsies prior to start, after two weeks (part a only) and upon progression of disease
boolean
C0027651 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
Measurable Disease
Item
measurable disease according to recist 1.1
boolean
C1513041 (UMLS CUI [1])
Organ function Laboratory Procedures
Item
adequate organ system function measured by laboratory values
boolean
C0678852 (UMLS CUI [1,1])
C0022885 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment.
boolean
C0013230 (UMLS CUI [1])
Cancer Other | Exception Disease Free Duration | Exception Skin carcinoma Resected Completely | Exception Second malignancy indolent | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Leptomeningeal Neoplasm Symptomatic | Leptomeningeal Neoplasm Untreated
Item
history of another malignancy exception part a: patients who have been disease-free for at least 3 years, or patients with a history of completely resected non-melanoma skin cancer and/or patients with indolent second malignancies are eligible. exception part b: adequately treated carcinoma in situ of the cervix and adequately treated basal cell carcinoma of the skin. 3. symptomatic or untreated leptomeningeal disease.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1521996 (UMLS CUI [3,3])
C0205197 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0085183 (UMLS CUI [4,2])
C0234227 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0851140 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0007117 (UMLS CUI [6,2])
C1522326 (UMLS CUI [6,3])
C0751297 (UMLS CUI [7,1])
C0231220 (UMLS CUI [7,2])
C0751297 (UMLS CUI [8,1])
C0332155 (UMLS CUI [8,2])
Metastatic malignant neoplasm to brain Symptomatic
Item
symptomatic brain metastasis.
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Combined Modality Therapy Interferes with Epidermal Growth Factor Receptor | Combined Modality Therapy Interferes with HER2 | Combined Modality Therapy Interferes with HER3 | Combined Modality Therapy Interferes with HER4 | Combined Modality Therapy Interferes with Mitogen-Activated Protein Kinases Component | Combined Modality Therapy Interferes with Phosphatidylinositol 3-Kinases Component | Combined Modality Therapy Interferes with PTEN inhibitors | Combined Modality Therapy Interferes with Phosphatidylinositol 3-Kinases inhibitors | Combined Modality Therapy Interferes with AKT1 inhibitors | Combined Modality Therapy Interferes with AKT2 inhibitors | Combined Modality Therapy Interferes with AKT3 inhibitors | Combined Modality Therapy Interferes with mTOR Inhibitor | Combined Modality Therapy Interferes with B-Raf inhibitor | Combined Modality Therapy Interferes with MEK Inhibitor
Item
patients previously treated with any drug combination known to interfere with egfr, her2, her3, her4 or mapk- and pi3k-pathway components, including inhibitors of pten, pi3k, akt, mtor, braf, mek and erk.
boolean
C0009429 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0034802 (UMLS CUI [1,3])
C0009429 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0069515 (UMLS CUI [2,3])
C0009429 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0072460 (UMLS CUI [3,3])
C0009429 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0812267 (UMLS CUI [4,3])
C0009429 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0752312 (UMLS CUI [5,3])
C1705248 (UMLS CUI [5,4])
C0009429 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2936824 (UMLS CUI [6,3])
C1705248 (UMLS CUI [6,4])
C0009429 (UMLS CUI [7,1])
C0521102 (UMLS CUI [7,2])
C0694888 (UMLS CUI [7,3])
C0243077 (UMLS CUI [7,4])
C0009429 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C2936824 (UMLS CUI [8,3])
C0243077 (UMLS CUI [8,4])
C0009429 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0812228 (UMLS CUI [9,3])
C0243077 (UMLS CUI [9,4])
C0009429 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C0812230 (UMLS CUI [10,3])
C0243077 (UMLS CUI [10,4])
C0009429 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C1332074 (UMLS CUI [11,3])
C0243077 (UMLS CUI [11,4])
C0009429 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C2746052 (UMLS CUI [12,3])
C0009429 (UMLS CUI [13,1])
C0521102 (UMLS CUI [13,2])
C4521853 (UMLS CUI [13,3])
C0009429 (UMLS CUI [14,1])
C0521102 (UMLS CUI [14,2])
C2347168 (UMLS CUI [14,3])
Lung Diseases, Interstitial | Pneumonitis
Item
history of interstitial lung disease or pneumonitis
boolean
C0206062 (UMLS CUI [1])
C3714636 (UMLS CUI [2])
Therapeutic radiology procedure | Immunotherapy | Chemotherapy | Palliative Radiation Therapy allowed
Item
radio-, immuno- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. palliative radiation (1x 8gy) is allowed.
boolean
C1522449 (UMLS CUI [1])
C0021083 (UMLS CUI [2])
C0392920 (UMLS CUI [3])
C3898008 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Disorder of eye
Item
opthalmological diseases
boolean
C0015397 (UMLS CUI [1])
Left ventricular ejection fraction
Item
patients with left ventricular ejection fraction (lvef) < 55%
boolean
C0428772 (UMLS CUI [1])
Comorbidity Cardiac
Item
patients with cardiac comorbidities
boolean
C0009488 (UMLS CUI [1,1])
C1522601 (UMLS CUI [1,2])
CYP1A2 Inhibitors | CYP1A2 Inducers | CYP2C19 Inhibitors | CYP2C19 Inducers | CYP3A4 Inhibitors | CYP3A4 Inducers | CYP3A5 Inhibitors | CYP3A5 Inducers | P-Glycoprotein Inhibitors | P-Glycoprotein Inducers
Item
concomitant or recent use (in the past 14 days) of strong inhibitors and inducers of cyp1a2, cyp2c19, cyp3a4, 3a5 and p-glycoprotein (p-gp)
boolean
C3850068 (UMLS CUI [1])
C3850050 (UMLS CUI [2])
C3850059 (UMLS CUI [3])
C3850047 (UMLS CUI [4])
C3850053 (UMLS CUI [5])
C3850041 (UMLS CUI [6])
C3850054 (UMLS CUI [7])
C3850043 (UMLS CUI [8])
C3500483 (UMLS CUI [9])
C3883353 (UMLS CUI [10])
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