UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005934 |
|---|---|
| Receipt number | R000007015 |
| Scientific Title | Phase II Trial of Erlotinib Plus Bevacizumab for Patients with Advanced Non-Small-Cell Lung Cancer Who harboring EGFR mutation. |
| Date of disclosure of the study information | 2011/07/05 |
| Last modified on | 2011/07/05 21:49:02 |
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Basic information
Public title
Phase II Trial of Erlotinib Plus Bevacizumab for Patients with Advanced Non-Small-Cell Lung Cancer Who harboring EGFR mutation.
Acronym
Phase II Trial of Erlotinib Plus Bevacizumab for Patients with Advanced Non-Small-Cell Lung Cancer Who harboring EGFR mutation.
Scientific Title
Phase II Trial of Erlotinib Plus Bevacizumab for Patients with Advanced Non-Small-Cell Lung Cancer Who harboring EGFR mutation.
Scientific Title:Acronym
Phase II Trial of Erlotinib Plus Bevacizumab for Patients with Advanced Non-Small-Cell Lung Cancer Who harboring EGFR mutation.
Region
| Japan |
Condition
Condition
Non Small Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Erlotinib and Bevacizumab in patients with EGFR mutation positive non-squamous NSCLC who failed Bevacizumab containing regimen.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression Free Survival
Key secondary outcomes
Response Rate, Disease Control Rate, Overall Survival, Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Bevacizumab, Erlotinib
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) StageIIIB/IV or postoperative recurrence Non-small cell lung cancer and Non-Squamous cell carcinoma proven by histology and/or cytology
2) No prior chemotherapy except for Bevacizumab containing regimen as 1st line treatment.
3) Patients who completed more than three cycles of Bevacizumab containing regimen and experienced PD.
4) EGFR mutation (Exon19 or Exon21)
5) More than 20 years old.
6) PS 0-2
7) At least one or more measurable lesion by RECIST.
8) Interval
-Palliative radiotherapy >2wks
-Surgery >4wks
-thoracic drainage>2wks
-biopsy with dissection, indwelling port >2wks
-aspiration biopsy cytology >1wks
9) Adequate organ function
10) Life expectancy more than three months.
11) Written Informed Consent
Key exclusion criteria
1) Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.).
2) EGFR-TKI resistance EGFR mutation (T790M)
3) Prior treatment with Gefitinib or Erlotinib.
4) Unavailability of oral administration.
5) History of hemoptysis.
6) Tumor invasion to major vessels
7) History of gastrointestinal perforation or diverticulitis or fistula
8) History of cardiac infarction or brain infarction.
9) Scheduled operation.
10) Uncontrollable hypertension.
11) Symptomatic brain metastasis.
12) A history of allergic reaction for the treatment drugs.
13) Uncontrollable pleural effusion or peritoneal effusion.
14) History of severe comorbidity disease.
15) History of active double cancer.
16) Unstable psychic disorder.
17) Pregnant patients.
18) Decision of ineligibility by a physician.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Yokoi |
Organization
Kansai Medical University Hirakata
Hospital
Division name
Respiratory medicine
Zip code
Address
2-3-1 Shin-machi, Hirakata-shi, Osaka 573-1191 JAPAN
TEL
072-804-0101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Yokoi |
Organization
Kansai Medical University Hirakata Hospital
Division name
Respiratory medicine
Zip code
Address
2-3-1 Shin-machi, Hirakata-shi, Osaka 573-1191 JAPAN
TEL
072-804-0101
Homepage URL
yokoit@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University Hirakata Hospital
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
関西医科大学附属枚方病院（大阪府）
Kansai Medical University Hirakata Hospital
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | 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
| 2011 | Year | 07 | Month | 05 | Day |
Last modified on
| 2011 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007015
