Colorectal Cancer
Conditions
Brief summary
Progression free survival (PFS), as determined by the Investigator per RECIST v1.1 of DKN-01 plus standard care (SOC) versus SOC in all patients with advanced colorectal cancer and in patients with left-sided advanced colorectal cancer.
Detailed description
Objective response rate (ORR), as determined by the Investigator per RECIST v1.1 of DKN-01 plus SOC versus SOC, Duration of response (DoR), as determined by the Investigator per RECIST v1.1 of DKN-01 plus SOC versus SOC, Overall survival (OS) with DKN-01 plus SOC versus SOC., Incidence of ≥Grade 3 related treatment-related adverse events (TRAEs)
Interventions
Sponsors
Leap Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS), as determined by the Investigator per RECIST v1.1 of DKN-01 plus standard care (SOC) versus SOC in all patients with advanced colorectal cancer and in patients with left-sided advanced colorectal cancer. | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR), as determined by the Investigator per RECIST v1.1 of DKN-01 plus SOC versus SOC, Duration of response (DoR), as determined by the Investigator per RECIST v1.1 of DKN-01 plus SOC versus SOC, Overall survival (OS) with DKN-01 plus SOC versus SOC., Incidence of ≥Grade 3 related treatment-related adverse events (TRAEs) | — |
Countries
Germany
Outcome results
None listed