UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016583
Receipt number R000019239
Scientific Title ZELBORAF Special Drug Use Surveillance (Malignant Melanoma)
Date of disclosure of the study information 2015/02/26
Last modified on 2023/05/30 17:05:16

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Basic information

Public title

ZELBORAF Special Drug Use Surveillance (Malignant Melanoma)

Acronym

ZELBORAF Special Drug Use Surveillance (Malignant Melanoma)

Scientific Title

ZELBORAF Special Drug Use Surveillance (Malignant Melanoma)

Scientific Title:Acronym

ZELBORAF Special Drug Use Surveillance (Malignant Melanoma)

Region

Japan


Condition

Condition

Malignant Melanoma

Classification by specialty

Dermatology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The primary objective is to determine the following items under the conditions of actual clinical use of Zelboraf in a long-term follow-up period (24 months) according to the post-approval commitments.
1. Incidence of adverse drug reactions (ADRs)
2. Unlabeled ADRs
3. Overall Survival (OS)
4. Factors thought to affect safety and effectiveness

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Adverse reaction incidence

Key secondary outcomes

Effectiveness
OS


Base

Study type

Observational


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

All patients planning to use Zelboraf during the enrollment period

Key exclusion criteria

No criteria

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Nomura
Middle name
Last name Makoto

Organization

Chugai Pharmaceutical Co. Ltd.

Division name

Safety science Dept

Zip code

103-8324

Address

1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japa

TEL

03-3281-6611

Email

nomuramkt@chugai-pharm.co.jp


Public contact

Name of contact person

1st name Ryousuke
Middle name
Last name Harada

Organization

Chugai Pharmaceutical Co. Ltd.

Division name

Safety science Dept

Zip code

103-8324

Address

1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan

TEL

03-3281-6611

Homepage URL


Email

haradarus@chugai-pharm.co.jp


Sponsor or person

Institute

Chugai Pharmaceutical Co. Ltd.

Institute

Department

Personal name



Funding Source

Organization

Chugai Pharmaceutical Co. Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

None

Address

None

Tel

None

Email

None


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

2015 Year 02 Month 26 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

Open public recruiting

Date of protocol fixation

2015 Year 01 Month 19 Day

Date of IRB


Anticipated trial start date

2015 Year 02 Month 26 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patent baseline characteristics,Treatment history of primary disease,Treatment history of non-primary disease,Treatment status,Concomitant drugs,Combination therapy,Outcome,Patient transfer information,Post-transfer information,Adverse events (AEs),Follow-up items for cases of serious adverse events


Management information

Registered date

2015 Year 02 Month 19 Day

Last modified on

2023 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019239


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name