UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041453
Receipt number R000047322
Scientific Title Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors: a systematic review and meta-analysis.
Date of disclosure of the study information 2020/08/18
Last modified on 2021/02/17 10:30:50

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Basic information

Public title

Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors: a systematic review and meta-analysis.

Acronym

Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors: a systematic review and meta-analysis.

Scientific Title

Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors: a systematic review and meta-analysis.

Scientific Title:Acronym

Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors: a systematic review and meta-analysis.

Region

Japan Asia(except Japan) North America
South America Australia Europe
Africa


Condition

Condition

tumors

Classification by specialty

Pneumology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Adverse events of combined Dabrafenib Plus Trametinib in the treatment of tumors

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

category fo adverse event

Key secondary outcomes

frequency of adverse event


Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

12 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

treated with dabrafenib and trametinib

Key exclusion criteria

Without frequency or category of adverse event

Target sample size



Research contact person

Name of lead principal investigator

1st name Kou
Middle name
Last name Chin

Organization

Yokohama city university

Division name

pulmonology

Zip code

2360004

Address

3-9 Fukuura, Kanazawa, Yokohama 236-0004, Japan

TEL

045-352-7962

Email

chinksmd@yahoo.co.jp


Public contact

Name of contact person

1st name Kou
Middle name
Last name Chin

Organization

Yokohama city university

Division name

Pulomonology

Zip code

2360004

Address

3-9 Fukuura, Kanazawa, Yokohama 236-0004, Japan

TEL

045-352-7962

Homepage URL


Email

chinksmd@yahoo.co.jp


Sponsor or person

Institute

3-9 Fukuura, Kanazawa, Yokohama 236-0004, Japan

Institute

Department

Personal name



Funding Source

Organization

3-9 Fukuura, Kanazawa, Yokohama 236-0004, Japan

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Yokohama city university

Address

3-9 Fukuura, Kanazawa, Yokohama 236-0004, Japan

Tel

045-352-7962

Email

chinksmd@yahoo.co.jp


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

2020 Year 08 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

Terminated

Date of protocol fixation

2020 Year 08 Month 18 Day

Date of IRB

2020 Year 08 Month 18 Day

Anticipated trial start date

2020 Year 08 Month 18 Day

Last follow-up date

2020 Year 08 Month 18 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2020 Year 08 Month 18 Day

Last modified on

2021 Year 02 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047322


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name