ID

38394

Descripción

A Phase I/II Study of Continuous Oral Treatment With BIBF 1120 Added to Standard Gemcitabine/Cisplatin Therapy in First Line NSCLC Patients With Squamous Cell Histology.; ODM derived from: https://clinicaltrials.gov/show/NCT01346540

Link

https://clinicaltrials.gov/show/NCT01346540

Palabras clave

Versiones (1)
  1. 15/10/19 15/10/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

15 de octubre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Carcinoma, Non-Small-Cell Lung NCT01346540

Inglés

Eligibility Carcinoma, Non-Small-Cell Lung NCT01346540

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
run-in phase i
Descripción

Run-in Period Number

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3274438
UMLS CUI [1,2]
C0237753
1. histologically or cytologically confirmed diagnosis of stage iiib/iv or recurrent non small cell lung cancer (nsclc) with squamous cell histology.
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0278517
UMLS CUI [2,2]
C0221910
UMLS CUI [2,3]
C4048239
2. measurable disease according to response evaluation criteria in solid tumours ( recist 1.1).
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
3. patient eastern cooperative oncology group (ecog) score of 0-1.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
4. male or female patients age = 18 years.
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
5. life expectancy of at least three (3) months.
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
6. written informed consent in accordance with international conference on harmonisation- good clinical practice (ich-gcp) guidelines.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
phase ii - in addition to the above criteria:
Descripción

Run-in Period Number

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3274438
UMLS CUI [1,2]
C0237753
7. radiologically-confirmed at least stable disease after 2 prior cycles of cisplatin /
Descripción

Stable Disease | Status post Chemotherapy cycle Quantity Cisplatin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0677946
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1302181
UMLS CUI [2,3]
C1265611
UMLS CUI [2,4]
C0008838
gemcitabine chemotherapy.
Descripción

Gemcitabine Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0045093
UMLS CUI [1,2]
C0392920
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. prior therapy for advanced or metastatic or recurrent non small cell lung cancer (nsclc). one prior adjuvant, neoadjuvant or adjuvant + neoadjuvant treatment is allowed if at least 12 months have elapsed between the end of the treatment and randomization
Descripción

Prior Therapy Non-Small Cell Lung Carcinoma Advanced | Prior Therapy Non-small cell lung cancer metastatic | Prior Therapy Non-small cell lung cancer recurrent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0007131
UMLS CUI [1,3]
C0205179
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0278987
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0278517
2. prior treatment with other vascular endothelial growth factor receptor (vegfr) inhibitors (other than bevacizumab)
Descripción

VEGFR Inhibitor | Exception Bevacizumab

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2985521
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0796392
3. any contraindications for treatment with gemcitabine and/or cisplatin.
Descripción

Medical contraindication Gemcitabine | Medical contraindication Cisplatin

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0045093
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0008838
4. use of any investigational drug within 4 weeks of entering the 1199.82 study.
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
5. history of major thrombotic or clinically relevant bleeding event in the past 6 months.
Descripción

Hemorrhage Thrombotic Major | Hemorrhage Clinical Relevant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0087086
UMLS CUI [1,3]
C0205164
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C0205210
UMLS CUI [2,3]
C2347946
6. significant cardiovascular diseases (i.e. hypertension not controlled by medication.
Descripción

Cardiovascular Diseases | Uncontrolled hypertension

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C1868885
7. surgery within 4 weeks (except tumour biopsy) prior randomisation and incomplete wound healing.
Descripción

Operative Surgical Procedures | Exception Tumor Biopsy | Wound Healing Incomplete

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0543467
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0027651
UMLS CUI [2,3]
C0005558
UMLS CUI [3,1]
C0043240
UMLS CUI [3,2]
C0205257
8. active brain metastases
Descripción

Metastatic malignant neoplasm to brain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
9. radiotherapy (except extremities) within 3 months prior to baseline imaging and radiotherapy for brain metastasis < 4 weeks prior baseline imaging.
Descripción

Therapeutic radiology procedure | Exception Extremities | Therapeutic radiology procedure Metastatic malignant neoplasm to brain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0015385
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0220650
10. any other current malignancy or malignancy diagnosed within the past five (5) years.
Descripción

Cancer Other

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
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Similar models

Eligibility Carcinoma, Non-Small-Cell Lung NCT01346540

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Run-in Period Number
Item
run-in phase i
boolean
C3274438 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Non-Small Cell Lung Carcinoma TNM clinical staging | Non-small cell lung cancer recurrent Squamous Cell Histology
Item
1. histologically or cytologically confirmed diagnosis of stage iiib/iv or recurrent non small cell lung cancer (nsclc) with squamous cell histology.
boolean
C0007131 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0278517 (UMLS CUI [2,1])
C0221910 (UMLS CUI [2,2])
C4048239 (UMLS CUI [2,3])
Measurable Disease
Item
2. measurable disease according to response evaluation criteria in solid tumours ( recist 1.1).
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
3. patient eastern cooperative oncology group (ecog) score of 0-1.
boolean
C1520224 (UMLS CUI [1])
Age
Item
4. male or female patients age = 18 years.
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
5. life expectancy of at least three (3) months.
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
6. written informed consent in accordance with international conference on harmonisation- good clinical practice (ich-gcp) guidelines.
boolean
C0021430 (UMLS CUI [1])
Run-in Period Number
Item
phase ii - in addition to the above criteria:
boolean
C3274438 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Stable Disease | Status post Chemotherapy cycle Quantity Cisplatin
Item
7. radiologically-confirmed at least stable disease after 2 prior cycles of cisplatin /
boolean
C0677946 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1302181 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0008838 (UMLS CUI [2,4])
Gemcitabine Chemotherapy
Item
gemcitabine chemotherapy.
boolean
C0045093 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Prior Therapy Non-Small Cell Lung Carcinoma Advanced | Prior Therapy Non-small cell lung cancer metastatic | Prior Therapy Non-small cell lung cancer recurrent
Item
1. prior therapy for advanced or metastatic or recurrent non small cell lung cancer (nsclc). one prior adjuvant, neoadjuvant or adjuvant + neoadjuvant treatment is allowed if at least 12 months have elapsed between the end of the treatment and randomization
boolean
C1514463 (UMLS CUI [1,1])
C0007131 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0278987 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0278517 (UMLS CUI [3,2])
VEGFR Inhibitor | Exception Bevacizumab
Item
2. prior treatment with other vascular endothelial growth factor receptor (vegfr) inhibitors (other than bevacizumab)
boolean
C2985521 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0796392 (UMLS CUI [2,2])
Medical contraindication Gemcitabine | Medical contraindication Cisplatin
Item
3. any contraindications for treatment with gemcitabine and/or cisplatin.
boolean
C1301624 (UMLS CUI [1,1])
C0045093 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0008838 (UMLS CUI [2,2])
Investigational New Drugs
Item
4. use of any investigational drug within 4 weeks of entering the 1199.82 study.
boolean
C0013230 (UMLS CUI [1])
Hemorrhage Thrombotic Major | Hemorrhage Clinical Relevant
Item
5. history of major thrombotic or clinically relevant bleeding event in the past 6 months.
boolean
C0019080 (UMLS CUI [1,1])
C0087086 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
C0019080 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C2347946 (UMLS CUI [2,3])
Cardiovascular Diseases | Uncontrolled hypertension
Item
6. significant cardiovascular diseases (i.e. hypertension not controlled by medication.
boolean
C0007222 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
Operative Surgical Procedures | Exception Tumor Biopsy | Wound Healing Incomplete
Item
7. surgery within 4 weeks (except tumour biopsy) prior randomisation and incomplete wound healing.
boolean
C0543467 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0027651 (UMLS CUI [2,2])
C0005558 (UMLS CUI [2,3])
C0043240 (UMLS CUI [3,1])
C0205257 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain
Item
8. active brain metastases
boolean
C0220650 (UMLS CUI [1])
Therapeutic radiology procedure | Exception Extremities | Therapeutic radiology procedure Metastatic malignant neoplasm to brain
Item
9. radiotherapy (except extremities) within 3 months prior to baseline imaging and radiotherapy for brain metastasis < 4 weeks prior baseline imaging.
boolean
C1522449 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0015385 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0220650 (UMLS CUI [3,2])
Cancer Other
Item
10. any other current malignancy or malignancy diagnosed within the past five (5) years.
boolean
C1707251 (UMLS CUI [1])
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