Regorafenib for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether regorafenib, a type of cancer treatment, works better or worse than the usual combination chemotherapy for metastatic colorectal cancer. It targets individuals whose cancer has spread to other parts of the body and either have not received treatment for this stage or whose cancer worsened after initial treatment. Participants should have colorectal cancer that cannot be surgically removed and has spread to organs like the liver or lungs. The trial aims to compare how well regorafenib controls cancer against standard treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor to get a clear answer based on your specific situation.
Is there any evidence suggesting that regorafenib is likely to be safe for humans?
Research has shown that regorafenib is generally tolerable for patients with solid tumors, including colorectal cancer. Common side effects include fatigue and other symptoms.
One study found that regorafenib helped extend the lives of patients with colorectal cancer, although side effects occurred. Doctors manage these side effects during treatment.
As a phase 2 study, the treatment has already undergone safety testing in earlier trials, but researchers continue to monitor patient tolerance closely. This trial aims to determine if regorafenib offers a better option for colorectal cancer than standard treatments.12345Why do researchers think this study treatment might be promising?
Regorafenib is unique because it works by blocking specific enzymes that promote cancer cell growth, which is different from the standard chemotherapy treatments typically used for colorectal cancer. Unlike traditional options that may target rapidly dividing cells more generally, regorafenib specifically targets proteins involved in tumor growth and blood supply, potentially leading to more precise and effective treatment. Researchers are excited about regorafenib because it offers a targeted approach, which might reduce side effects while effectively managing metastatic colorectal cancer.
What evidence suggests that regorafenib might be an effective treatment for colorectal cancer?
Research has shown that regorafenib, the treatment under study in this trial, can help treat advanced colorectal cancer. In earlier studies, regorafenib slowed tumor growth and reduced the spread of cancer cells. Specifically, patients who took regorafenib experienced an average of about 2.4 months before the cancer worsened and lived for an average of about 4.76 months. These studies suggest that regorafenib can combat tumors and is a manageable treatment option for this condition.23678
Who Is on the Research Team?
Andrea Cercek, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults over 18 with newly diagnosed metastatic colorectal adenocarcinoma who haven't been treated or have progressed after first-line therapy. They must have good organ function, a life expectancy of at least 3 months, and be able to take oral meds. Women must not be pregnant and all participants should agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive regorafenib for three weeks on and one week off, evaluated for response every 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Regorafenib
Regorafenib is already approved in United States, European Union for the following indications:
- Metastatic colorectal cancer
- Gastrointestinal stromal tumors (GIST)
- Hepatocellular carcinoma (HCC)
- Metastatic colorectal cancer
- Gastrointestinal stromal tumors (GIST)
- Hepatocellular carcinoma (HCC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Queens Cancer Center of Queens Hospital
Collaborator
State University of New York - Downstate Medical Center
Collaborator
Bayer
Industry Sponsor
Bill Anderson
Bayer
Chief Executive Officer since 2023
BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT
Michael Devoy
Bayer
Chief Medical Officer since 2014
MD, PhD