Solid Cancer not curable with, or not eligible for standard treatment(s)
Conditions
Sponsors
DAIICHISANKYO Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically or cytologically diagnosed metastatic solid cancers which are not curable with, or not eligible for standard treatment(s) -ECOG performance status: 0-1
Exclusion criteria
Exclusion criteria: -History of any of the following events within 6 months prior to start of study treatment myocardial infraction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident or cerebral infraction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event, clinically significant pulmonary disease (eg severe COPD or asthma) -Patient with a clinically active brain metastasis, or who need drugs to control adverse event like edema and pleural effusion -Inflammatory bowel disease, or partial bowel obstruction -Patients with any severe or uncontrolled intercurent diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Pharmacokinetics To evaluate the safety profile according to CTCAE To evaluate the pharmacokinetics according to the protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of the recommended dose Preliminary anti-tumor effect of CS-7017 Preliminary biomarker study of CS-7017 To study potential biomarker of CS-7017 activity according to the protocol To evaluate anti-tumor effect according to RECIST | — |
Outcome results
None listed