UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007515 |
|---|---|
| Receipt number | 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 09:04:57 |
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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
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
atsushi.horiike@jfcr.or.jp
Sponsor or person
Institute
Japanese Foundation for Cancer Research
Cancer Institute Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008866
