UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009603 |
|---|---|
| Receipt number | R000011263 |
| Scientific Title | Phase II study evaluating Erlotinib/Bevacizumab therapy as a second line therapy for advanced relapsed EGFR mutation positive non-squamous NSCLC patients who received first line combination therapy including platinum and Bevacizumab |
| Date of disclosure of the study information | 2012/12/21 |
| Last modified on | 2012/12/21 12:02:32 |
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Basic information
Public title
Phase II study evaluating Erlotinib/Bevacizumab therapy as a second line therapy for advanced relapsed EGFR mutation positive non-squamous NSCLC patients who received first line combination therapy including platinum and Bevacizumab
Acronym
Phase II study evaluating Erlotinib/Bevacizumab therapy as a second line therapy for advanced relapsed EGFR mutation positive non-squamous NSCLC patients who received first line combination therapy including platinum and Bevacizumab
Scientific Title
Phase II study evaluating Erlotinib/Bevacizumab therapy as a second line therapy for advanced relapsed EGFR mutation positive non-squamous NSCLC patients who received first line combination therapy including platinum and Bevacizumab
Scientific Title:Acronym
Phase II study evaluating Erlotinib/Bevacizumab therapy as a second line therapy for advanced relapsed EGFR mutation positive non-squamous NSCLC patients who received first line combination therapy including platinum and Bevacizumab
Region
| Japan |
Condition
Condition
non-squamous non-small-cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Surgery in general |
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Erlotinib/Bevacizumab therapy as a second line therapy for advanced relapsed EGFR mutation positive non-squamous NSCLC patients who received first line combination therapy including platinum and Bevacizumab
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Disease control rate, Progression free survival, Overall survival, Safety, Search for predictive factors
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
Patients evaluated progression disease during platinum combination therapy including Bevacizumab, will receive Erlotinib / Bevacizumab therapy as the secondary cemotherapy
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. Patients at the age of 20 and over
2. Confirmed as StageIIIB(unsuitable for definitive radiotherapy), StageIV, or recurrent after surgery
* Patients of at least 6 months after the last course of adjuvant chemotherapy
3. non-squamous NSCLC
4. EGFR mutation positive(exon19, 21)
5. Patients with life expectancy for more than 3 months
6. Eastern Cooperative Oncology Group performance status of 0-2
7. Patients with measurable disease based on Response Evaluation Criteria in Solid Tumors(RECIST)ver.1.1.
* radiation sites are not counted as measurable lesions
8. Advanced relapsed EGFR mutation positive non-squamous NSCLC patients evaluated progression disease during first line combination therapy including platinum and Bevacizumab
9. Patients with adequate organ function as following
Neutrocyte count >= 1,500/mm3
Hemoglobin >= 9.0 g/dL
Platelet count >= 100,000/mm3
Aspartate aminotransferase and alanine aminotransferase < 2.5 times the upper limit of normal
Total bilirubin <= 1.5mg/dL
Serum creatinine <= 1.5mg/dL
PT-INR < 1.5
Urine protein <= +1
* Confirmed by test results within 2 weeks before registration date. The same day of the week 2 weeks before enrollment cannot be included
10. At the time of the expected date of the beginning of treatment, patients with the following period has elapsed since prior treatments
No radiotherapy except for thoracic radiation within a week (exclude chest)
No Exploratory thoracotomy within 4 weeks
No pleural drainage within a week
11. Patients with sensitive EGFR mutation confirmed by PCR
12. Written informed consent can be obtained
Key exclusion criteria
1. Patients treated with EGFR-TKI
2. Patients with T790M mutation
3. Patients with history or combination of interstitial lung disease (interstitial pneumonia, pneumonitis, radiation pneumonia, BOOP, pulmonary fibrosis, ARDS, pulmorary infiltration, alveolitis, etc), and lung infection
4. Patients complicated with corneal disease, which is a problem in the clinical
5. Patients with intestinal diverticulitis
6. Patients with symptomatic brain metastases
7. Patients with history or complication of hemoptysis
*Definition of hemoptysis is determined as the following.
A history of continuous hemoptysis over one week, or hemoptysis receiving oral or intravenous hemostatic medicine
8. Patients with a history of severe drug allergy
9. Patients with uncontrolled ascites, pleural effusion, or pericardial effusion
10. Patients with a history of gastrointestinal perforation within an year, or a complication of uncontrollable peptic ulcer
11. Patients with uncontrolled hypertension
12. Patients with infectious disease requiring systemic administration of antiviral agents, antifungal agents, or antibiotics
13. Patients receiving antiplatelet therapy
*Patients receiving aspirin therapy up to 325mg are allowed to be registered
14. Patients with a history of radiation to the chest, or more than 20% region of bones with hematopoietic ability
15. Patients with multiple cancers within 5 years prior to initiation of the study, except for carcinoma in situ, mucosal cancer appropriately treated non-melanoma, cervical cancer, thyroid cancer, early gastric cancer, early colorectal cancer
16. Patients with serious complications (such as heart disease, active infection, interstitial pneumonia, diabetes)
17. Pregnant woman or those with suspected pregnancy, nursing woman and those who plan to become pregnant during the study period
18. Other patients whom the investigator considers to be unsuitable for participation in the study
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Tanzawa |
Organization
Showa University Northern Yokohama Hospital
Division name
Respiratory Center
Zip code
Address
Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL
045-949-7000
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Tanzawa |
Organization
Showa University Northern Yokohama Hospital
Division name
Respiratory Center
Zip code
Address
Chigasaki-chuo 35-1 Tsuzuki-ku, Yokohama 224-503, Japan.
TEL
045-949-7000
Homepage URL
Sponsor or person
Institute
Respiratory Center, Showa University Northern Yokohama Hospital
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
昭和大学横浜市北部病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 21 | Day |
Last modified on
| 2012 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011263
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