Regorafenib for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication called Regorafenib (also known as Stivarga, BAY 73-4506, or Regonix) to assess its safety and tolerability for people with glioblastoma, a type of brain cancer that has returned or worsened after treatment with bevacizumab. The trial aims to assist patients who have undergone previous treatments but still face challenges with their condition. Suitable participants have glioblastoma, have tried bevacizumab, and have experienced cancer returning or progressing despite treatment. As a Phase 2 trial, this research focuses on measuring 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 requires you to stop any current anti-cancer therapy and certain medications like warfarin and herbal remedies such as St. John's wort. If you're on corticosteroids, you must be on a stable or decreasing dose before starting the trial.
Is there any evidence suggesting that Regorafenib is likely to be safe for humans?
Research has shown that regorafenib is generally safe, consistent with previous findings. Importantly, these studies reported no deaths related to the drug. However, serious side effects occurred in about 56% of patients. Because these side effects can vary, participants must be monitored closely. The FDA has already approved regorafenib for other uses, indicating a certain level of established safety. However, individual reactions can differ with any treatment.12345
Why do researchers think this study treatment might be promising for glioblastoma?
Regorafenib is unique because it targets multiple pathways involved in tumor growth and blood vessel formation, offering a novel approach for treating glioblastoma, especially in cases where the tumor has become resistant to Avastin. Unlike standard treatments, regorafenib inhibits several protein kinases, which can help slow down the progression of this aggressive brain cancer. Researchers are particularly excited about its potential to overcome resistance in glioblastoma, providing hope for improved outcomes in a condition with limited effective treatment options.
What evidence suggests that Regorafenib might be an effective treatment for glioblastoma?
Research has shown that regorafenib, the treatment under study in this trial, may aid in treating glioblastoma, particularly for patients whose cancer has returned after other treatments. Studies have found that regorafenib can extend patient survival compared to lomustine, with patients living an average of 7.4 months instead of 5.6 months. Regorafenib blocks certain proteins that promote tumor growth, potentially slowing or halting cancer progression. Overall, early evidence suggests that regorafenib could be a promising option for those with recurrent glioblastoma.23467
Who Is on the Research Team?
David Peereboom, MD
Principal Investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with recurrent glioblastoma who have previously not responded to bevacizumab treatment. They must have certain blood and organ function levels, agree to use contraception if of childbearing potential, and cannot have other concurrent cancers (with some exceptions). Participants need a life expectancy of at least 12 weeks and should not be on any conflicting medications or treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 160 mg regorafenib 3 weeks on/one week off until progression or toxicity
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?
Case Comprehensive Cancer Center
Lead Sponsor