UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase 2 Study of imatinib in c-kit mutant Advanced Melanoma
Title of the study (Brief title)	MM_CKIT
Region	Japan

Condition
Condition	Malignant melanoma
Classification by specialty	Dermatology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	evaluate the safety and efficacy of the chemotherapy using imatinib for Unresectable or Metastatic c-kit mutant Malignant Melanoma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall Response Rate, Safety
Key secondary outcomes	Progression-free Survival

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	Subjects will take 400mg of imatinib every day after meal.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	In order to be eligible for participation in this trial, the subject must: 1) Be male or female subjects, age 20 years or older on day of signing consent. 2) Have histologically or cytologically confirmed malignant melanoma. 3) Have Unresectable or Metastatic c-kit mutant melanoma. 4) Have received standard therapy. 5) Have been untreated for advanced or metastatic disease by imatinib. 6) Have resolution of toxic effects of the most recent prior therapy. 7) Have the presence of at least one measurable lesion by image per RECIST 1.1. 8) Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1. 9) Has no-central nerve system (CNS) metastasis or asymptomatic CNS metastasis. 10) Agreed to use an adequate method of contraception within the project duration of the study, starting with the visit through 120 days after the last dose of the study treatment. 11) Have laboratory parameters within Protocol-defined range. The screening laboratory tests below must be < 14 days before treatment initiation. a) white blood cell count >= 2,000/mm3, absolute neutrophil count >= 1,500/mm3 b) Platelets >= 100,000/mm3 c) Hemoglobin >= 9 g/dL d) Bilirubin <= 2.0 mg/dL e) Aspartate aminotransferase (AST), alanine aminotransferase (ALT) <= 150 IU/L g) Serum creatinine <= 1.5 mg/dL 12) Provide written informed consent for the study.
Key exclusion criteria	Exclusion Criteria The subject must be excluded from participation in the trial if the subject: 1) Has known history of Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA is detected). 2) Has known history of human immunodeficiency virus (HIV). 3) Has active infection, clinically significant cardiac disease, including unstable angina and arrhythmia, psychiatric disorder. 4) Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Target sample size	21

Research contact person
Name of lead principal investigator	Takeru Funakoshi
Organization	Keio University School of Medicine
Division name	Department of Dermatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	+81-3-5363-3823
Email	takeruf@a8.keio.jp

Public contact
Name of contact person	Ikuko Hirai
Organization	Keio University School of Medicine
Division name	Department of Dermatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	+81-3-5363-3823
Homepage URL
Email	hiraiku@keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Keio University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 11 Month 08 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 11 Month 08 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 08 Day
Last modified on	2019 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034143