UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007123 |
|---|---|
| Receipt number | R000008389 |
| Scientific Title | A Phase II Study of Bevacizumab (Avastin®) in Combination with Standard Second line chemotherapy (Docetaxel Or Pemetrexed) in Patients with Non-Squamous Non-Small-Cell Lung Cancer previously Treated with chemotherapy |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2019/04/24 15:56:05 |
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Basic information
Public title
A Phase II Study of Bevacizumab (Avastin®) in Combination with Standard Second line chemotherapy (Docetaxel Or Pemetrexed) in Patients with Non-Squamous Non-Small-Cell Lung Cancer previously Treated with chemotherapy
Acronym
ADOPT study
Scientific Title
A Phase II Study of Bevacizumab (Avastin®) in Combination with Standard Second line chemotherapy (Docetaxel Or Pemetrexed) in Patients with Non-Squamous Non-Small-Cell Lung Cancer previously Treated with chemotherapy
Scientific Title:Acronym
ADOPT study
Region
| Japan |
Condition
Condition
Non-sq NSCLC with previously treated
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Bevacizumab in combination with Docetaxel or Pemetrexed for patients previously treated with combining chemotherapy.
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
disease control rate,overall survival, and 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
Bevasizumab + Pemetrexed
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) Pathologically or cytplogically confirmed non-small cell lung cancer.
Patients with clinical stage IIIB/IV or postoperative recurrence, and unsuitable for radiotherapy.
(2) Previously treated
(3) Patients who has measurable by RECIST(ver 1.1)criteria.
(4) performance status of 0-2
(5) Age of 20 years or older
(6) Adequate organ functions
(7) Life expectancy more than 90 days
(8) Written informed consent
Key exclusion criteria
(1) Previously untreated with platinum doublet
(2) transfusion or G-CSF within 2weeks prior to enrollment
(3) Severe renal function disorder, 2+ or higher proteinuria within 2 weeks prior to enrollment
(4) History of severe drug allergy
(5) History of active double cancer within 5 years
(6) History of active severe infections
(7) Patients who have fever of over 38 degrees
(8) Continuous administration of steroid drug
(9) severe cardiac disease
(10) History of thromboembolism or severe pulmonary disease
(11) History of GI bleeding , ileus, GI ulceration
(12) massive pleural or pericardial effusion, ascites
(13) Symptomatic brain metastases
(14) Uncontrollable hypertension or diabetes mellitus
(15) Uncontrollable diarrhea
(16) Wound of unrecovery
(17) Traumatic fracture of unrecovery
(18) bleeding diathesis or receiving anticoagulant drug(except Aspirin under 324mg/day)
(19) History of pregnancy or lactation
(20) Evaluated to be ineligible by a physician for other reasons
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Fujitaka |
Organization
Hiroshima University Hospital
Division name
Respiratory medicine
Zip code
Address
1-2-3 kasumi , minami-ku, Hiroshima, 734-8551, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Fujitaka |
Organization
Hiroshima University Hospital
Division name
Respiratory medicine
Zip code
Address
TEL
81-082-257-5195
Homepage URL
Sponsor or person
Institute
Hiroshima University Hospital
Respiratory medicine
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
| 2012 | Year | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 23 | Day |
Last modified on
| 2019 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008389
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