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])
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])