UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010582 |
|---|---|
| Receipt number | 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 | 2020/11/12 10:43:39 |
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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
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
sakiko.o@kitasato-u.ac.jp
Sponsor or person
Institute
Thoracic Oncology Research Group
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10637-020-01031-z
Number of participants that the trial has enrolled
25
Results
-
Results date posted
| 2020 | Year | 11 | Month | 12 | Day |
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
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012367
