UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029890
Receipt number R000034143
Scientific Title Phase 2 Study of imatinib in c-kit mutant Advanced Melanoma
Date of disclosure of the study information 2017/11/08
Last modified on 2019/01/26 18:08:48

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Basic information

Public title

Phase 2 Study of imatinib in c-kit mutant Advanced Melanoma

Acronym

MM_CKIT

Scientific Title

Phase 2 Study of imatinib in c-kit mutant Advanced Melanoma

Scientific Title:Acronym

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

1st name
Middle name
Last name Takeru Funakoshi

Organization

Keio University School of Medicine

Division name

Department of Dermatology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

+81-3-5363-3823

Email

takeruf@a8.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ikuko Hirai

Organization

Keio University School of Medicine

Division name

Department of Dermatology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL

+81-3-5363-3823

Homepage URL


Email

hiraiku@keio.jp


Sponsor or person

Institute

Keio University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2017 Year 11 Month 08 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034143


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name