UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015944 |
|---|---|
| Receipt number | R000018477 |
| Scientific Title | Afatinib with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring EGFR mutation:phaseI study |
| Date of disclosure of the study information | 2014/12/16 |
| Last modified on | 2019/06/06 11:44:57 |
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Basic information
Public title
Afatinib with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring EGFR mutation:phaseI study
Acronym
Afatinib with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring EGFR mutation:phaseI study
Scientific Title
Afatinib with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring EGFR mutation:phaseI study
Scientific Title:Acronym
Afatinib with bevacizumab as first-line therapy in patients with advanced non-squamous non-small-cell lung cancer harboring EGFR mutation:phaseI study
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate feasibility and recommended dose of combination therapy of afatinib with bevacizumab as first line therapy for non-small cell lung cancer patients with sensitive EGFR mutation
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Incidence rates of dose limiting toxicity (DLT) in each therapy dose
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
the combination therapy of afatinib with bevacizumab
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically or cytologically proven non-squamous cell carcinoma NSCLC
2) EGFR mutation (exon19 deletion or L858R in exon 21)
3) Unresectable or impossible of radical radiotherapy
4) IIIB/IV or postoperative recurrence
5) Chemotherapy naive
6) No radiation therapy for tumor in lung
7) Measurable disease for RECIST ver.1.1
8) Age: over 20
9) PS(ECOG): 0-1
10)Adequate organ functions judged by laboratory tests
11)Life expectancy: over 3 months
12)Written informed consent
Key exclusion criteria
1) EGFR mutation (exon20)
2) Symptomatic brain metastases
3) Leptomeningeal carcinomatosis
4) Active double cancer
5) Hemoptysis or hemosputum
6) Hemophilic arthritis
7) Antiplatelet drug or anticoagulant
8) Uncontrolled high tension
9) Invasion to major arteries or vessels
10) Cavity of lung tumor
11) Therapy needed effusion (pleural or pericardial or ascites)
12) SVC syndrome
13) Interstitial pneumonitis or pneumonia
14) Gastrointestinal disturbance
15) Severe allergic history
16) Pregnancy
17) Inadequate patients whom physitians considered
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Kiura |
Organization
Okayama University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
2-5-1, Shikatacho, Okayama, Japan
TEL
086-223-7151
tninomiya5@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Ninomiya |
Organization
Okayama University Hospital
Division name
Department of Respiratory Medecine
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan
TEL
086-235-7227
Homepage URL
tninomiya5@gmail.com
Sponsor or person
Institute
Okayama Lung Cancer Study Group (OLCSG)
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 10 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 14 | Day |
Last modified on
| 2019 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018477
