臨床研究等提出・公開システム

Date of registration	Oct. 20, 2017
Last modified on	June. 29, 2022
Trial ID	jRCT2080223687

Scientific Title	A Phase II, Open-label, Study in Subjects with BRAF V600E- Mutated Rare Cancers with Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib
Public Title

Completion Date or Terminated date	Dec. 10, 2021
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	Yes
Plan description	Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number	+81-120-003-293
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries
	Address
	Phone Number	+81-120-003-293
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		Nov. 13, 2017
Target Sample Size		206
Study Type		Interventional
Study Design	Study Design
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria
	Exclusion Criteria
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied
Intervention(s)		investigational material(s) Generic name etc : INN of investigational material : Dabrafenib Mesilate Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Generic name etc : INN of investigational material : Trametinib Dimethyl Sulfoxide Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : control material(s) Generic name etc : INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material :
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy
Secondary Outcome		safety exploratory

Primary Sponsor	Novartis Pharma K.K.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 03, 2017

Secondary ID No.	NCT02034110
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-173743
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/North America/Europe

History of Changes

No	Publication date
3	June. 29, 2022	(this page)	Changes
2	June. 28, 2018	Detail	Changes
1	Oct. 20, 2017	Detail

List of change history