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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017053
Receipt No. R000019708
Scientific Title Phase I study of tamibarotene for relapse or refractory pediatric solid tumor
Date of disclosure of the study information 2015/04/09
Last modified on 2017/10/13

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Basic information
Public title Phase I study of tamibarotene for relapse or refractory pediatric solid tumor
Acronym TBT-PI
Scientific Title Phase I study of tamibarotene for relapse or refractory pediatric solid tumor
Scientific Title:Acronym TBT-PI
Region
Japan

Condition
Condition Relapse or refractory pediatric solid tumor
Classification by specialty
Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine a recommend dose of tamibarotene and to assess its pharmacokinetics in patients with relapse or refractory pediatric solid tumor.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Dose limiting toxicity (DLT)
Key secondary outcomes 1)Adverse events
2)Clinical Benefit Rate(CBR)
3)Pharmacokinetics and dose-response for tamibarotene


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 Tamibarotene is orally administered twice a day in 1-14or1-21 days.
28days per a course,up to 8 courses.
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
3 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria 1)Aged 3 to 30 years old
2)Histologically proven sarcoma, blastoma, germ cell tumors, CNS except malignant lymphoma
3)Relapse or progression following disease-specific standard chemotherapies
4)Site by With evaluable disease
5)PS(Karnofsky or Lansky) >= 50%
6)7 days or more have passed since last use of anti-tumor agents which are continuously-administered and 14 days or more have passed since last use of anti-tumor agents which are not administered continuously
7)No prior irradiation within 12 weeks if radiation fields contain either whole brain and spine, whole abdomen, whole lung, whole body, or more than 50% of pelvis. No prior irradiation within 6 weeks if radiation fields contain either less than 50% of pelvis, or 5 or less vertebras. No prior irradiation within 14 days if radiation fields are limited.
8)No difficulty to take soft capsule or tablet
9)Normal organ function confirmed by laboratory tests within 14 days
10)Written informed consent from patient and/or legal guardian
Key exclusion criteria 1)Synchronous or asynchronous(within 5 years)other cancer except carcinoma in situ or intramucosal carcinoma
2)Active infection requires systemic therapy
3)Any abnormalities in electrocardiogram tested within 28 days, which require intervention
4)Respiratory disorder requiring oxygen supply
5)Woman during pregnancy, or impossible to discontinue breast-feeding from within 1 month prior to enrollment to 2 years after the final dose of study treatment. Woman without intent to use birth control from within 1 month prior to enrollment to 2 years after the final dose of study treatment. Man without intent to use birth control from within 1 month prior to enrollment to 2 years after the final dose of study treatment.
6)Severe psychiatric disorder
7)Patients with history of allergy to tamibalotene
8)Patients with history of treatment with tamibarotene
9)In patients having a brain tumor or metastasis to brain, a symptom with the intracranial hypertension is poor in control
10)Patients otherwise considered ineligible for enrollment in the study by the investigator
Target sample size 21

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiro Sato
Organization National Cancer Center Hospital East
Division name Office of Clinical Research Support
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Email DACTBT@ml.res.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Sato
Organization National Cancer Center Hospital East
Division name Office of Clinical Research Support
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Homepage URL
Email DACTBT@ml.res.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Division of Pediatric Oncology
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 国立がん研究センター中央病院(東京都)
大阪市立総合医療センター(大阪府)
九州大学病院(福岡県)
国立がん研究センター東病院(千葉県)

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 09 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
2015 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 09 Day
Last follow-up date
2017 Year 04 Month 08 Day
Date of closure to data entry
2017 Year 04 Month 21 Day
Date trial data considered complete
2017 Year 10 Month 01 Day
Date analysis concluded
2017 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 06 Day
Last modified on
2017 Year 10 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019708

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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