Unique ID issued by UMIN | UMIN000016029 |
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Receipt number | R000018636 |
Scientific Title | Phase I study of afatinib + bevacizumab for advanced NSCLC with EGFR mutation |
Date of disclosure of the study information | 2014/12/22 |
Last modified on | 2018/12/25 18:41:16 |
Phase I study of afatinib + bevacizumab for advanced NSCLC with EGFR mutation
Phase I study of afatinib + bevacizumab for advanced NSCLC with EGFR mutation
Phase I study of afatinib + bevacizumab for advanced NSCLC with EGFR mutation
Phase I study of afatinib + bevacizumab for advanced NSCLC with EGFR mutation
Japan |
Non-small cell lung cancer
Pneumology |
Malignancy
NO
To investigate feasibility, maximum tolerated dose and recommended phase II dose of afatinib + bevacizumab therapy for non-small cell lung cancer patients with EGFR mutation.
Safety
Phase I
To conclude maximum tolerated dose and recommended phase II dose.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Combination therapy of afatinib + bevacizumab
20 | years-old | <= |
75 | years-old | > |
Male and Female
1)Histologically or cytologically proven non-small cell lung cancer
2)Harboring sensitive EGFR mutation
3)Stage IIIB, IV, relapse post operation and no indication for operation and curative irradiation
4)Having measurable disease for RECIST ver. 1.1
5)More than 20 years old and less than 75 years old
6)Performance status: 0-1
7)Life expectancy: over 90 days
8)Adequate organ functions
9)PaO2 >= 70torr or SpO2 >= 95% at room air
10)Written informed consent
1)Active double cancer
2)Interstitial pneumonitis on chest CT
3)Symptomatic brain metastases
4)Uncontrollable pleural effusion or pericardial effusion
5)Having hemoptysis
6)Having risk factor of bleeding
7)Gastrointestinal ulcer or past history of gastrointestinal perforation
8)Uncontrollable hyper tension
9)Active infectious disease
10)Receiving steroids or immunosuppressants
11)Receiving consecutive oxygen therapy
12)Inadequate period from open surgery
13)Planning open surgery
14)Pregnant or breastfeeding woman
15)History of severe allergy
16)Having other severe complications
17)Patients whose physicians considered as inappropriate for this clinical study
20
1st name | |
Middle name | |
Last name | Kazuhisa Takahashi |
Juntendo University
Department of Respiratory Medicine
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
03-5802-1062
kztakaha@juntendo.ac.jp
1st name | |
Middle name | |
Last name | Ryo Ko, Takehito Shukuya |
Juntendo University
Department of Respiratory Medicine
3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
03-5802-1062
rkou@juntendo.ac.jp
Juntendo University
Juntendo University
Self funding
NO
2014 | Year | 12 | Month | 22 | Day |
Unpublished
Completed
2014 | Year | 11 | Month | 08 | Day |
2015 | Year | 01 | Month | 05 | Day |
2014 | Year | 12 | Month | 22 | Day |
2018 | Year | 12 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018636
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