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Regorafenib

Regorafenib is an oral medication being studied in clinical trials for various types of cancer, including colorectal cancer, liver cancer, and bone tumors. This article summarizes key information about ongoing clinical trials investigating regorafenib’s effectiveness, safety, and potential biomarkers in cancer patients who have not responded to standard treatments.

Table of Contents

What is Regorafenib?

Regorafenib is a medication used to treat various types of cancer. It’s also known by its brand name Stivarga[1]. Regorafenib belongs to a class of drugs called multikinase inhibitors, which means it works by blocking several proteins that help cancer cells grow and spread[2].

What Conditions Does Regorafenib Treat?

Regorafenib has been approved and is being studied for several types of cancer:

  • Colorectal Cancer: It’s used to treat metastatic colorectal cancer (cancer that has spread from the colon or rectum to other parts of the body) in patients who have already tried other standard treatments[1].
  • Gastrointestinal Stromal Tumors (GIST): Regorafenib is approved for patients with GIST that has progressed after treatment with other therapies[3].
  • Hepatocellular Carcinoma (HCC): This is a type of liver cancer. Regorafenib is being studied as a second-line treatment for patients with unresectable HCC (liver cancer that cannot be surgically removed)[4].
  • Glioblastoma: Research is ongoing to evaluate regorafenib’s effectiveness in treating this aggressive type of brain cancer[2].
  • Esophageal and Gastric Cancer: Studies are investigating the use of regorafenib in combination with other treatments for these types of cancers[5].

How Does Regorafenib Work?

Regorafenib works by targeting multiple proteins involved in cancer growth and progression. Specifically, it inhibits:

  • Angiogenesis: This is the process by which tumors create new blood vessels to supply themselves with nutrients. Regorafenib blocks proteins called VEGFRs (Vascular Endothelial Growth Factor Receptors) that are crucial for this process[6].
  • Oncogenic signaling: The drug also inhibits proteins involved in cancer cell growth and survival, such as RAF and BRAF[6].
  • Tumor microenvironment: Regorafenib affects proteins that help create a favorable environment for tumor growth[6].

By targeting these multiple pathways, regorafenib aims to slow down or stop cancer growth and spread.

Dosage and Administration

Regorafenib is typically taken orally (by mouth) in the form of tablets. The standard dosage is often 160 mg once daily, but this can vary depending on the specific condition and individual patient factors[1]. Some important points about taking regorafenib:

  • It’s usually taken for 3 weeks, followed by a 1-week break. This 4-week period is considered one treatment cycle[7].
  • The medication should be taken with a light meal[3].
  • Some studies are exploring different dosing schedules, such as starting at a lower dose and gradually increasing it to improve tolerability[7].

Always follow your doctor’s instructions regarding dosage and administration.

Side Effects and Safety

Like all medications, regorafenib can cause side effects. Some of the most common include:

  • Fatigue
  • Diarrhea
  • Hand-foot skin reaction (redness, swelling, and pain on the palms of hands and soles of feet)
  • Loss of appetite
  • High blood pressure

These side effects can sometimes be severe, particularly in women and patients with lower body weight[3]. Your healthcare team will monitor you closely and may adjust your dose if needed. It’s important to report any side effects to your doctor promptly.

Ongoing Research and Future Potential

Researchers are continually studying regorafenib to understand how to use it most effectively and safely. Some areas of ongoing research include:

  • Combination therapies: Studies are looking at combining regorafenib with other treatments, such as immunotherapy drugs like sintilimab for liver cancer[4].
  • New cancer types: Researchers are investigating regorafenib’s potential in treating other types of cancer, such as meningioma (a type of brain tumor)[6].
  • Optimizing dosage: Studies are exploring ways to adjust the dosage based on factors like body composition to improve tolerability and effectiveness[3].
  • Adjuvant therapy: Some research is looking at using regorafenib as an additional treatment after main cancer therapy to prevent recurrence[8].

These ongoing studies aim to expand our understanding of regorafenib and potentially broaden its use in cancer treatment.

Aspect Details
Cancer Types Studied Colorectal cancer, hepatocellular carcinoma, angiosarcoma, osteosarcoma, Ewing sarcoma
Common Dosing 160 mg orally daily for 3 weeks, followed by 1 week off (28-day cycle)
Key Outcomes Measured Overall survival, progression-free survival, response rates, safety/tolerability
Common Side Effects Fatigue, hand-foot skin reaction, diarrhea, liver function abnormalities
Patient Population Advanced cancer patients who have progressed after standard treatments
Biomarker Research Some trials exploring genetic mutations, protein levels, and other biomarkers
Combination Studies Investigations of regorafenib with other drugs (e.g., XELOX chemotherapy)

FAQ

  • What types of cancer is regorafenib being studied for? Regorafenib is being investigated in clinical trials for several types of cancer, including metastatic colorectal cancer, hepatocellular carcinoma (liver cancer), angiosarcoma, and primary bone tumors like osteosarcoma and Ewing sarcoma.
  • How is regorafenib typically administered in these trials? In most trials, regorafenib is given orally once daily, often at a dose of 160 mg, for 3 weeks followed by a 1-week break in a 28-day cycle. However, some trials are exploring different dosing regimens or combinations with other drugs.
  • What are some of the main outcomes being measured in regorafenib trials? Key outcomes being assessed include overall survival, progression-free survival, tumor response rates, safety/tolerability, and quality of life. Some trials are also looking at biomarkers that may predict response to regorafenib.
  • Are there any notable side effects of regorafenib? Common side effects can include fatigue, hand-foot skin reaction, diarrhea, and liver function abnormalities. The trials closely monitor patients for adverse events and may adjust dosing if needed.
  • Who is typically eligible for these regorafenib clinical trials? Eligibility varies, but trials often include patients with advanced cancers that have progressed after standard treatments. Some focus on specific cancer types or molecular profiles. Patients must meet certain health criteria to participate safely.

Ongoing Clinical Trials on Regorafenib

  • Study of BMS-986288 and Nivolumab for Patients with Advanced Solid Tumors

    Not recruiting

    1 1 1
    Investigated drugs:
    France Italy Spain

  • Study on Botensilimab Alone and with Balstilimab or Drug Combination for Patients with Refractory Metastatic Colorectal Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Italy Spain

  • Study of Durvalumab and Regorafenib for Patients with Stage IV Colorectal Cancer with No Evidence of Disease

    Not recruiting

    1 1 1
    Investigated drugs:
    Italy

Glossary

  • Regorafenib: An oral medication that belongs to a class of drugs called kinase inhibitors. It works by blocking several proteins that promote cancer growth and blood vessel formation in tumors.
  • Metastatic: Cancer that has spread from its original site to other parts of the body.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives with cancer without it worsening.
  • Overall survival (OS): The length of time from the start of treatment or diagnosis that patients are still alive.
  • Response rate: The percentage of patients whose cancer shrinks or disappears after treatment.
  • Adverse event: Any unfavorable and unintended sign, symptom, or disease associated with the use of a medical treatment.
  • Biomarker: A measurable substance in the body that may indicate the presence of a disease, condition, or response to treatment.
  • Pharmacokinetics: The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors – a standard way to measure how well a cancer patient responds to treatment.
  • Tyrosine kinase inhibitor: A type of targeted therapy that blocks specific enzymes called tyrosine kinases, which are involved in cancer cell growth and survival.

References

  1. https://clinicaltrials.gov/study/NCT01959269
  2. https://clinicaltrials.gov/study/NCT02926222
  3. https://clinicaltrials.gov/study/NCT02439723
  4. https://clinicaltrials.gov/study/NCT04718909
  5. https://clinicaltrials.gov/study/NCT01913639
  6. https://clinicaltrials.eu/trial/study-on-regorafenib-for-patients-with-recurrent-grade-2-and-3-meningioma-after-surgery-and-radiotherapy/
  7. https://clinicaltrials.gov/study/NCT04450836
  8. https://clinicaltrials.gov/study/NCT05382741