UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017053 |
|---|---|
| Receipt number | 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 15:13:13 |
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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
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
DACTBT@ml.res.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Division of Pediatric Oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019708
