Malignant melanoma
Conditions
Interventions
Subjects will take 400mg of imatinib every day after meal.
Sponsors
Keio University
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate, Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free Survival | — |
Countries
Japan
Contacts
Public ContactIkuko Hirai
Keio University School of Medicine Department of Dermatology
Outcome results
None listed