The aim of this phase 1 trial is to study the effectiveness of treatment with AZD1775 combined with the chemotherapy irinotecan (Camptosar). The main outcome to be measured is the tumor response to the treatment and toxicity.
The details
Chemotherapy is a standard treatment to colorectal cancer. It reduces symptoms and prolongs survival. Chemotherapy agents attack cancer cells, slowing down cancer progression. Different chemotherapies, such as irinotecan, can be used and are often combined to increase effectiveness. AZD1775 is a treatment that inhibits (blocks) a protein (WEE1) involved in cancer growth.
The current trial will investigate the effectiveness of the combined treatment with irinotecan and AZD1775 in patients with RAS or BRAF-mutated (permanent change) colorectal cancer.
Who are they looking for?
The trial will recruit 32 participants. Patients must have progressive colorectal cancer with a RAS or BRAF mutation. Patients must be able to swallow AZD1775 capsules and must have normal blood levels. Patients must not have had treatment within 14 days prior the start of the study. Patients must not have received more than one line of previous treatment, a recent major surgery, or any severe disease. Patients must not have brain tumors. Female patients must not be pregnant or breastfeeding.
How will it work
Patients will be randomly assigned to receive different doses of the combined treatment. Irinotecan (180 mg/m2) will be given every two weeks. AZD1775 (125 mg or 150 mg) will be given two times a day for 3 days every 2 weeks or two times a day for 5 days every 2 weeks. Treatment will continue until disease progression or toxicity.
