Unique ID issued by UMIN | UMIN000029890 |
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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 |
Phase 2 Study of imatinib in c-kit mutant Advanced Melanoma
MM_CKIT
Phase 2 Study of imatinib in c-kit mutant Advanced Melanoma
MM_CKIT
Japan |
Malignant melanoma
Dermatology |
Malignancy
YES
evaluate the safety and efficacy of the chemotherapy using imatinib for
Unresectable or Metastatic c-kit mutant Malignant Melanoma
Safety,Efficacy
Exploratory
Phase II
Overall Response Rate, Safety
Progression-free Survival
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Subjects will take 400mg of imatinib every day after meal.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
21
1st name | |
Middle name | |
Last name | Takeru Funakoshi |
Keio University School of Medicine
Department of Dermatology
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
+81-3-5363-3823
takeruf@a8.keio.jp
1st name | |
Middle name | |
Last name | Ikuko Hirai |
Keio University School of Medicine
Department of Dermatology
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
+81-3-5363-3823
hiraiku@keio.jp
Keio University
Keio University
Self funding
NO
2017 | Year | 11 | Month | 08 | Day |
Unpublished
Terminated
2017 | Year | 11 | Month | 08 | Day |
2018 | Year | 04 | Month | 01 | Day |
2017 | Year | 11 | Month | 08 | Day |
2019 | Year | 01 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034143
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