Colorectal cancer
Conditions
Sponsors
DAIICHI SANKYO CO., LTD.
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >= 20 years in Japan, >= 18 years in the rest of the countries. - Pathologically documented unresectable, recurrent, or metastatic colorectal adenocarcinoma. Until sponsor's notification to the study sites, subject must be a RAS/BRAF wild-type cancer. - Received at least 2 prior regimens of standard treatment. - Has measurable disease assessed by the investigator based on RECIST version 1.1. - Has an ECOG PS of 0 to 1
Exclusion criteria
Exclusion criteria: - Medical history of myocardial infarction within 6 months, symptomatic congestive heart failure - Has a medical history of clinically significant lung disease - Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The objective response rate RECIST Version 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy pharmacokinetics Progression-free survival, Overall survival, Duration of response, Disease control rate, Safety, Pharmacokinetic RECIST Version 1.1 | — |
Countries
Europe, Japan, North America
Outcome results
None listed