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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010582
Receipt No. R000012367
Scientific Title Multicenter phase II study of amrubicin plus erlotinib in previously treated, advanced non-small cell lung cancer with wild-type epidermal growth factor receptor (TORG1320)
Date of disclosure of the study information 2013/04/26
Last modified on 2019/04/24

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Basic information
Public title Multicenter phase II study of amrubicin plus erlotinib in previously treated, advanced non-small cell lung cancer with wild-type epidermal growth factor receptor
(TORG1320)
Acronym Phase II study of amrubicin plus erlotinib in previously treated NSCLC patients with wild-type epidermal growth factor receptor (TORG1320)
Scientific Title Multicenter phase II study of amrubicin plus erlotinib in previously treated, advanced non-small cell lung cancer with wild-type epidermal growth factor receptor
(TORG1320)
Scientific Title:Acronym Phase II study of amrubicin plus erlotinib in previously treated NSCLC patients with wild-type epidermal growth factor receptor (TORG1320)
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To investigate efficacy and safety of amrubicin plus erlotinib for non-small cell lung cancer with wild type growth factor receptor
Basic objectives2 Others
Basic objectives -Others Additional study: measurement of serum level of erlotinib
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes progression free survival,
Key secondary outcomes response rate,
disease control rate,
time to treatment failure,
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 Induction phase
amrubicin35mg/m2 days 1-3, plus
erlotinib 100mg days 1- 21, 4 cycles
Maintenance phase
erlotinib 100mg, until progression
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1)pathologically proven non-small cell lung cancer stage IIIB/IV
2)wildb type EGFR
3)history of no more than two previos chemotherapis(includeing platinum doublet one regimen)
4)no prior treatment with anthracycline including amrubicin anad EGFR-TKI
5)patients who can receive oral anticancer agents
6)hospitarization during the first four weeks of treatment
7)between 20 and 74 years old
8)performance status (ECOG)0-1
9)measurable lesions by RECIST
10)sufficient function of main organ and bone marrow
11)estimated survival of at least 3 months
12)interval from previous treatment,
Chemotherapy:morethan 3 weeks
Radiation:more than 12 weeks after the last irradiation to another organs
13)signed informed consent
Key exclusion criteria 1)interstitial pneumonia or pulmonary fibrosis detectable on CT
2)3)smoking within 1 year
4)active severe infections
5)massive pleural effusion, ascites pericardial effusion
6)radiation of primary region or measurable region
5)history of sevirevere drug allergy
6)clinically important opthalmic disorders
7)brain metastasis associated with central nervous symptoms(patients were ineligible if the symptoms were controlled by steroids)
8)active concomitant cancers
9)history of concomitant cancers within 5 years
10)history of bone marrow transplant or peripheral stem cell transplantation
11)constant diarrhea
12)with intestinal paralysis or ileus
13)current or previous(within the last 1 year) of GI perfomation
14)uncontrollable ulcer in digestive tract
15)uncontrolled diabetes
16)current or history of severe heart disease
17)severe psychological disease
18)pregnant or lactating women or those who declined contraception
19)patients who were judged to be not suitable for trial by the attending physician
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriyuki Masuda
Organization Kitasato university School of Medicine
Division name Department of respiratory medicine
Zip code
Address 1-15-1, Kitasato Minami-ku Sagamihara Kanagawa 252-0374
TEL (042)778-8111
Email masuda@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sakiko Otani
Organization Kitasato university School of Medicine
Division name Department of respiratory medicine
Zip code
Address 1-15-1, Kitasato Minami-ku Sagamihara Kanagawa 252-0374
TEL (042)778-8111
Homepage URL http://www.torg.or.jp
Email sakiko.o@kitasato-u.ac.jp

Sponsor
Institute Thoracic Oncology Research Group
Institute
Department

Funding Source
Organization Thoracic Oncology Research Group
Organization
Division
Category of Funding Organization Non profit foundation
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
2013 Year 04 Month 26 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
2013 Year 02 Month 28 Day
Date of IRB
2013 Year 06 Month 07 Day
Anticipated trial start date
2013 Year 06 Month 15 Day
Last follow-up date
2017 Year 07 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 24 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012367

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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