UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017828 |
|---|---|
| Receipt number | R000020652 |
| Scientific Title | Phase II trial of the addition of bevacizumab to alectinib beyond progressive disease in ALK-positive advanced non-small-cell lung cancer. |
| Date of disclosure of the study information | 2015/06/05 |
| Last modified on | 2019/02/22 16:01:26 |
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Basic information
Public title
Phase II trial of the addition of bevacizumab to alectinib beyond progressive disease in ALK-positive advanced non-small-cell lung cancer.
Acronym
Phase II study of alectinib and bevacizumab for ALK-positive NSCLC (NLCTG1501)
Scientific Title
Phase II trial of the addition of bevacizumab to alectinib beyond progressive disease in ALK-positive advanced non-small-cell lung cancer.
Scientific Title:Acronym
Phase II study of alectinib and bevacizumab for ALK-positive NSCLC (NLCTG1501)
Region
| Japan |
Condition
Condition
ALK-positive 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 the addition of bevacizumab to alectinib treatment in patients who had responded to alectinib and then showed disease progression.
Basic objectives2
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
Overall Survival, Overall Response Rate, Disease Control Rate
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
Alectinib
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) Non-small cell lung cancer proven by histology and/or cytology
2) ALK-rearrangement confirmed by FISH, IHC or RT-PCR
3) Patients who had responded to alectinib and showed disease progression
4) 20 years or older
5)At least one or more measurable lesion by RECIST ver1.1
6) Performance status (ECOG) 0 to 1
7) Adequate organ function
8)Life expectancy more than twelve weeks
9)Written informed consent
Key exclusion criteria
1)Have hemosputum more than 2.5ml
2)Evidence of bleeding diathesis
3)Evidence of tumor invading a perihilar blood vessel or cavitation in intra-thoracic lesion on imaging
4)Evidence of thombosis on imaging
5)Have had or require continuous administration of warfarin, heparin, or aspirin at the dose of more than 324mg per day.
6)Have uncontrolable hypertension
7)Have interstital pneumonia or idiopathic pulmonary fibrosis on CT
8)Have grade 2 or more non-hematological toxicity by alectinib
9)Have symptomatic brain metastases
10)Radiotherapy for primiary lesion
11)Have any severe disease complications
12)Have severe infection including hepatitis B which requires anti-virus agents.
13)Have a history of active double cancer
14)Have severe digestion and absorption disorder
15)Have severe mental disorder
16)Patients whose participation in the trial is judged to be in appropriate by the doctor
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Kikuchi |
Organization
Niigata University Medical & Dental Hospital
Division name
Department of Respiratory and Infectious Diseases
Zip code
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8520, Japan
TEL
025-368-9326
kikuchi@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Watanabe |
Organization
Niigata University Medical & Dental Hospital
Division name
Department of Respiratory and Infectious Diseases
Zip code
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8520, Japan
TEL
025-368-9326
Homepage URL
satoshi7@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata Lung Cancer Treatment Group
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
| 2015 | Year | 06 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 09 | 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
| 2015 | Year | 06 | Month | 05 | Day |
Last modified on
| 2019 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020652
