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Recruitment status Completed
Unique ID issued by UMIN UMIN000015572
Receipt No. R000017901
Scientific Title A study to expand access to vemurafenib for patients with BRAFV600 mutation-positive unresectable/recurrent melanoma.
Date of disclosure of the study information 2014/11/01
Last modified on 2016/12/13

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Basic information
Public title A study to expand access to vemurafenib for patients with BRAFV600 mutation-positive unresectable/recurrent melanoma.
Acronym Vemurafenib(Expand Access Program)
Scientific Title A study to expand access to vemurafenib for patients with BRAFV600 mutation-positive unresectable/recurrent melanoma.
Scientific Title:Acronym Vemurafenib(Expand Access Program)

Condition melanoma
Classification by specialty
Classification by malignancy Malignancy
Genomic information NO

Narrative objectives1 To provide vemurafenib to patients with BRAFV600 mutation-positive unresectable/recurrent melanoma for whom few therapeutic options are available.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Primary outcomes Safety Outcome Measures
# Incidence, type, and severity of AEs
# Incidence and nature of serious adverse events (SAEs)
# Incidence of AEs leading to vemurafenib discontinuation or interruption
# Cause of death on study
Key secondary outcomes

Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Dynamic allocation
Institution consideration

No. of arms 1
Purpose of intervention Treatment
Type of intervention
Interventions/Control_1 Enrolled patients will receive
Vemurafenib at 960mg p.o. BID.

Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Patients who have been fully informed about the study and have given written consent themselves.
(2)Patients aged 20 years or older at the time of consent.
(3) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1 or 2
(4)Patients with evidence of the presence of BRAFV600 mutation in tumor tissue.
(5)Patients who have no treatment history of unresectable/recurrent melanoma or who have received at least one regimen for melanoma and had disease progression documented during or after treatment.
(6)Patients who have adequately recovered from the toxicity of the most recent systemic or local therapy for unresectable/recurrent melanoma.
(7)Adequate organ function as assessed by the following clinical laboratory parameters within 28 days prior to initiation of treatment:(Assessments conducted 4 weeks prior to the first dose of study drug [i.e., the same day of the previous week] will be allowed.)
1)ANC; 1500/mm3=<
2)Platelets; 100,000/mm3=<
3)Hemoglobin; 9.0 g/dL=<
4)Serum Creatinine; 1.5x upper limit of normal, or creatinine clearance > 50 mL/min
5)Serum direct Bilirubin; 1.5x upper limit of normal or; 5x ULN if concurrent liver metastases.
6)Serum AST and ALT; 2.5x upper limit of normal or;5x ULN if concurrent liver metastases.
(8)For women of childbearing potential, negative serum or urine pregnancy test within 7 days prior to treatment initiation.
(9)For women of childbearing potential and men who are partners of women of childbearing potential, willingness to practice effective contraception during the study and for 6 months after treatment discontinuation.
Key exclusion criteria (1)Patients with brain metastases
However, they will be eligible if they have only asymptomatic brain metastases treated by surgical resection or stereotaxic radiation therapy and diagnosed by the investigator/subinvestigators as being free of symptoms, with imaging evidence of stable disease.
(2)Patients with concurrent malignancies with a disease-free period of less than 2 years, except cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, and metastatic prostate cancer that has increased prostate-specific antigen (PSA) levels but is not clinically diagnosed by imaging
(3)Patients who are pregnant or nursing
(4)Patients with difficulty taking oral medications
(5)Patients who require concomitant use of other anticancer treatments (e.g., chemotherapy, other molecular-targeted agents, radiation therapy, and other investigational or experimental drugs)
(6)Patients who have had the following medical conditions within 6 months prior to the first dose of study drug:
Myocardial infarction, severe or unstable angina pectoris, symptomatic congestive heart failure, cerebrovascular disease or transient ischemic attack, pulmonary embolism, and inadequately controlled hypertension
(7)Patients with a mean corrected QT (QTc) interval of 450 msec or longer at screening
(8)Patients with Grade 2 (as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.0) or greater arrhythmia
(9)Patients with inadequately controlled concurrent medical conditions (e.g., those requiring intravenous antibiotic therapy)
(10)Patients who are unable to use acceptable methods of contraception
(11)Patients who are, in the opinion of the investigator/subinvestigators, ineligible for participation in the study for any other reason
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoya Yamazaki
Organization National Cancer Center Hospital
Division name Dermatology
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL 03-3542-2511

Public contact
Name of contact person
1st name
Middle name
Last name Naoya Yamazaki
Organization National Cancer Center Hospital
Division name Dermatology
Zip code
Address 5-1-1, Tsukiji, Chuo-ku,Tokyo,104-0045,Japan
TEL 03-3542-2511
Homepage URL

Institute National Cancer Center Hospital East

Funding Source
Organization Vemurafenib are provided gratis by Chugai pharm Co., Ltd. It is adopted as grant of expand access pilot program by Ministry of Health, Labour and Welfare.
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Name of secondary funder(s)

IRB Contact (For public release)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2

Institutions 国立研究開発法人 国立がん研究センター中央病院
国立研究開発法人 国立がん研究センター東病院

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

URL related to results and publications
Number of participants that the trial has enrolled
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

Recruitment status Completed
Date of protocol fixation
2014 Year 09 Month 04 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other related information

Management information
Registered date
2014 Year 10 Month 31 Day
Last modified on
2016 Year 12 Month 13 Day

Link to view the page

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name

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