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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021931
Receipt No. 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 2016/04/15

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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
Email 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
Email hgotou@kcmc.jp

Sponsor
Institute Kanagawa children's medical center
Institute
Department

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
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
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 Preinitiation
Date of protocol fixation
2016 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 18 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
2016 Year 04 Month 15 Day
Last modified on
2016 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025293

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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