None listed
Conditions
Interventions
Drug : 1) Dosage:
OMT-111: 100 mg/day
2) Duration of treatment:
1 cycle consists of 4 weeks (28 days). Each week consists of 5 days of treatment and 2 days of treatment-free interval (20 days of treat
Sponsors
MetiMedi Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female at least 19 years old or older at the time of informed consent 2) Histologically or cytologically confirmed carcinoma of the Colorectal 3) Patients who have unresectable metastatic lesion 4) ECOG PS (Eastern Cooperative Oncology Group Performance status) = 2 5) Patients with a life expectancy = 12 weeks as judged by the investigator 6) At least one measurable lesion or evaluable lesion defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 7) Voluntarily provided written consent to participate in this study
Exclusion criteria
Exclusion criteria: 1) History of malignancy other than metastatic colorectal cancer within 5 years prior to the first dose of investigational product (however, patients with effectively treated skin cancer, thyroid cancer, and carcinoma in situ that has been in complete remission for at least 3 years and thus considered cured by the investigator are eligible) 2) Uncontrolled CNS metastasis (however, patients with treated and stable brain metastasis (radiographically stable for at least 30 days) are eligible) 3) Primary cancer-related complication potentially requiring urgent surgery as judged by the investigator 4) Grade = 3 active infection requiring intravenous antibiotics per NCI-CTCAE version 5.0 5) Pregnant women, breast-feeding women or women with a positive pregnancy test at screening visit (Visit 1) 6) Previous treatment with the investigational product 7) Treatment with other investigational product within 30 days prior to the first dose of the investigational product 8) Patients who are otherwise considered to be ineligible for this study based on investigator’s judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control rate, DCR | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR;Duration of Response (DoR);Progression-Free Survival (PFS);18F-FDG- PET/CT (SUVmean and SUVmax) | — |
Countries
Korea, Republic of
Contacts
Public ContactJeong-Heum Baek
Gachon University Gil Medical Center
Outcome results
None listed