UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021931 |
|---|---|
| Receipt number | R000025293 |
| Scientific Title | Pilot Study of the combination of sorafenib and fractionated irinotecan in pediatric relapse/refractory hepatic cancer |
| Date of disclosure of the study information | 2016/04/18 |
| Last modified on | 2023/10/20 17:48:01 |
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Basic information
Public title
Pilot Study of the combination of sorafenib and fractionated irinotecan in pediatric relapse/refractory hepatic cancer
Acronym
FINEX Pilot Study
Scientific Title
Pilot Study of the combination of sorafenib and fractionated irinotecan in pediatric relapse/refractory hepatic cancer
Scientific Title:Acronym
FINEX Pilot Study
Region
| Japan |
Condition
Condition
Pediatric hepatoblastoma and hepatocellular carcinoma
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of irinotecan and sorafenib
for combination therapy to determine the safe dose
of irinotecan when used in combination to sorafenib
for children intractable liver cancer.The dose of
irinotecan is a two level formed 50 mg per square
meter for 5 days or 50 mg per square meter for
10days settled the dosageby 3plus3 design.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment doselimiting toxicity in combined
therapy irinotecan and sorafenib.
Key secondary outcomes
Ratio of Serious Adverse Event(SAE) AFP rate after chemotherapy
Change rate indicated size of tumor and
number of lesions after chemotherapy Progression
free survival PFS ,Over survival rate(OS) for 6 months
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 (po) 200mg twice a day 5days
irinotecan (iv) 20mg per squaremeters 5 or 10 days.
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
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hepatoblastoma or hepatocellular carcinoma patients with relapsed or refractory of less than this treatment at the start of age 18 years of age.
Before starting this treatment, be enforced two or more types of chemotherapy, 8.2. Partial response or more effects can not be obtained.
Patient with unresectable and multiple metastatic lesions
Patients and if the image on the tumor can not be detected, the serum AFP level indicates a more than 10 ng ml, and serum AFP level increase continued more
two times in the two weeks.
In ECOG score PS 0 to 2.
Have sufficient organ function, satisfies the following criteria.
AST and ALT less than five times the facility criteria
TBil 2.0 mg dl less than.
Creatinine clearance 71 ml min 1.73 m2 or more
There is no abnormality with the treatment 12lead electrocardiogram
Consent from was obtained patient or legal representative.
14 days not administered to other chemotherapies.
Key exclusion criteria
Active infection controls.
Congenital or Acquired immunodeficiency syndrome AIDS .
Determined ineligible by doctor.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Goto |
Organization
Kanagawa children's medical center
Division name
Blood and regenerative department
Zip code
Address
Mutsugawa 2-138-4,Minami-ward,Yokohama-city
TEL
0457112351
hgotou@kcmc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Goto |
Organization
Kanagawa children's medical center
Division name
Blood and regenerative department
Zip code
Address
Mutsugawa 2-138-4,Minami-ward,Yokohama-city
TEL
0457112351
Homepage URL
hgotou@kcmc.jp
Sponsor or person
Institute
Kanagawa children's medical center
Institute
Department
Personal name
Funding Source
Organization
Kanagawa children's medical center
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
| 2016 | Year | 04 | Month | 18 | 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
| 2016 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 15 | Day |
Last modified on
| 2023 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025293
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
