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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017828
Receipt No. 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

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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
Email 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
Email satoshi7@med.niigata-u.ac.jp

Sponsor
Institute Niigata Lung Cancer Treatment Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020652

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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