What is the PROCEADE CRC-03 Study?
The PROCEADE CRC-03 Study is a Phase 3 clinical study of an investigational medicine for adults with previously treated metastatic colorectal cancer.
In Phase 3, the goal is to confirm earlier findings of safety and efficacy in a larger group of people so doctors and regulators can understand the investigational medicine more clearly.
Who can participate?
The study is enrolling adults with metastatic colorectal cancer that has been previously treated. To be eligible, you must meet these and other requirements which the study doctor will discuss with you.
Age
At least 18 years of age
Diagnosis
Metastatic colorectal cancer
Treatment history
In general, 2 prior lines of therapy against colorectal cancer are needed
Health status
Independent and able to carry on normal daily activities
Screening Period
You will have health checks and tests to see if you are eligible for the study. This will take no more than 28 days.
Study Treatment Period
You have an equal chance of receiving 1 of 3 treatments: the investigational study medicine alone, the investigational study medicine combined with a standard of care anti-cancer medicine, or an approved standard of care combination anti-cancer regimen. You will receive your study treatment in cycles and visit the study clinic for checkups, tests, and scans.
Study treatment will continue as long as it is safe and helpful for you and you agree to continue. You can choose to withdraw your consent and leave the study at any time for any reason. Other reasons for stopping may include cancer progression, intolerable side effects, or other medical reasons.
Follow-up Period
There is a Safety Follow-up Visit 30 days after your last dose of study treatment, then phone calls about every 3 months.
What health checks & tests can I expect?
You will be monitored closely by the study doctor and staff. Checkups may include some or all of the following procedures:
- Physical exams
- Vital signs
- Blood tests
- Urine tests
- Tumor scans
- Electrocardiogram (ECG) heart tests
- Questionnaires
