UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007515
Receipt No. R000008866
Scientific Title Pilot study of sorafenib for RET fusion positive non-small cell lung cancer
Date of disclosure of the study information 2012/03/15
Last modified on 2015/03/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Pilot study of sorafenib for RET fusion positive non-small cell lung cancer
Acronym Sorafenib for RET fusion positive non-small cell lung cancer
Scientific Title Pilot study of sorafenib for RET fusion positive non-small cell lung cancer
Scientific Title:Acronym Sorafenib for RET fusion positive non-small cell lung cancer
Region
Japan

Condition
Condition RET fusion positive non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the safety and efficacy of thesorafenib therapy in RET fusion positive non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes feasibility
Key secondary outcomes

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 Sorafenib is given a dose of 400mg/body twice daily.
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)Histologically or cytologically confirned advanced non-small-cell lung cancer
2)RET fusion positive non-small-cell lung cancer
3)One or more previous chemotherapy regimens
4)Subjects must be off prior chemotherapy
at least 3 weeks prior to study entry.
5)Subjects who received radiotherapy to chest must have completed treatment at least 12 weeks prior to study entry.
6)Subjects who received radiotherapy to any site without chest must have completed treatment at least 2 weeks prior to study entry.
7)Subjects who received intrapleural therapy for malignant pleural effusions must have completed treatment at least 2 weeks prior to study entry.
8)ECOG Performance status 0-2
9)more than 20 years old
10)Adequate organ function
11)Life expectancy at least 3 months
12)Signed informed consent
Key exclusion criteria 1)Serious complications
2)Brain metastases need raidotherapy
3)Subjects with interstitial pneumonia or pulmonary fibrosis by chest X-ray
4)Patients who can not take orally.
5)Patients who have serious hypersensitivity reaction.
6)Patients who receive prohibited treatments.
7)Pregnancy, breast feeding or wish of future bearing
8)Concurrent use of steriod therapy except for topical or inhaled
9)Active infectious disease
10)Pleural effusion, peritoneal fluid, and pericardial fluid need drainage therapy
11)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size 3

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Nishio
Organization Japanese Foundation for Cancer Research
Cancer Institute Hospital
Division name Department of Thoracic Medical Oncology
Zip code
Address 3-8-31 Ariake Kotoku Tokyo Japan
TEL 03-3520-0111
Email mnishio@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Horiike
Organization Japanese Foundation for Cancer Research Cancer Institute Hospital
Division name Department of Thoracic Medical Oncology
Zip code
Address 3-8-31 Ariake Kotoku Tokyo Japan
TEL 03-3520-0111
Homepage URL
Email atsushi.horiike@jfcr.or.jp

Sponsor
Institute Japanese Foundation for Cancer Research
Cancer Institute Hospital
Institute
Department

Funding Source
Organization Japanese Foundation for Cancer Research
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
2012 Year 03 Month 15 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
2012 Year 03 Month 07 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 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
2012 Year 03 Month 15 Day
Last modified on
2015 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008866

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.