Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sumitomo Pharma Co., Ltd.
Age
20–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Phase 1
Histologically confirmed diagnosis of Malignant Pleural Mesothelioma (MPM) or Non-Small Cell Lung Cancer (NSCLC).
Measurable disease as defined by the modified Response Evaluation Criteria in Solid Tumors (mRECIST) for MPM or the RECIST 1.1 for NSCLC.
≥ 20 years of age.
Provision of written informed consent.
For male or female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days after the last protocol treatment dose.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Hemoglobin (Hb) ≥ 9.0 g/dL.
Neutrophils ≥ 1500/μL.
Platelets ≥ 100,000/μL.
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5-fold the upper limit of normal range (ULN) \[≤ 5-fold ULN with any liver metastasis\].
Females of childbearing potential have a negative urine pregnancy test.
Phase 2
Histologically confirmed diagnosis of MPM.
Treatment naïve and not indicated for resection.
Measurable disease as defined by the modified RECIST.
≥ 20 years of age.
Provision of written informed consent.
For male or female patient of child producing potential: Must agree to use contraception or take measures to avoid pregnancy during the study and for 30 days after the last protocol treatment dose.
ECOG Performance Status of 0 or 1.
Hb ≥ 9.0 g/dL.
Neutrophils ≥ 1500/μL.
Platelets ≥ 100,000/μL.
AST and ALT ≤ 2.5-fold ULN \[≤ 5-fold ULN for patients with any liver metastasis\].
