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

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 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


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

Value
https://center6.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