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Study on Regorafenib for Patients with Recurrent Grade 2 and 3 Meningioma After Surgery and Radiotherapy

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What is this study about?

This clinical trial is focused on studying a type of brain tumor called meningioma, specifically grades 2 and 3, which are more aggressive forms of this tumor. The study is investigating the effects of a medication called Regorafenib, also known by its code name BAY73-4506. This medication is a type of drug known as a multi-kinase inhibitor, which works by blocking certain proteins that help cancer cells grow. The purpose of the study is to see if Regorafenib can help slow down the progression of the disease in patients whose tumors have returned after surgery and radiation therapy.

Participants in the study will be randomly assigned to receive either Regorafenib or a placebo, which is a substance with no active medication. The study will take place over a period of time, during which participants will take the medication in the form of film-coated tablets. The maximum daily dose of Regorafenib is 160 milligrams, and the treatment period can last up to 18 months. Throughout the study, participants will have regular check-ups and tests, such as MRI scans, to monitor the size and growth of their tumors.

The main goal of the study is to determine if Regorafenib can extend the time patients live without their disease getting worse, known as progression-free survival. Additionally, the study will look at overall survival, which is the time from the start of the study until death from any cause, and the response of the tumor to the treatment. The study will also assess the quality of life of participants using specific questionnaires and record any side effects experienced during the treatment. The study is expected to continue until the end of 2026.

1 joining the study

Upon joining the study, the participant will be required to sign an informed consent form (ICF) to confirm understanding and voluntary participation.

Eligibility will be confirmed based on specific criteria, including a life expectancy of at least 6 months and the ability to take oral medication.

2 initial assessment

An initial assessment will be conducted to ensure all eligibility criteria are met, including adequate cardiac, liver, renal, and hematological function.

Baseline measurements will be taken, including a magnetic resonance imaging (MRI) scan to document any measurable lesions.

3 treatment phase

The treatment involves taking Stivarga (regorafenib) 40 mg film-coated tablets orally.

The dosage and frequency will be determined by the study protocol, and participants will be monitored for any side effects.

4 monitoring and follow-up

Participants will have regular follow-up visits to monitor the progression of the disease and any side effects from the medication.

Quality of life will be assessed using specific questionnaires designed for cancer patients.

5 end of study

The study is estimated to conclude by December 31, 2026.

Final assessments will be conducted to evaluate the overall survival and progression-free survival of participants.

Who Can Join the Study?

  • You must understand and voluntarily sign an informed consent form before any study-related activities.
  • You should have a life expectancy of at least 6 months.
  • You need to have a sample of your tumor tissue available for testing.
  • If you are taking dexamethasone or a similar steroid, the dose should be 4 mg or less per day within 7 days before starting the study.
  • Your steroid dosage should be stable or decreasing for 7 days before starting the study.
  • You must have a healthy heart and proper liver, kidney, and blood function.
  • Your blood tests should show:
    • Enough white blood cells without needing extra support.
    • Hemoglobin (a protein in red blood cells) of at least 10 g/dL.
    • Enough platelets, which help with blood clotting.
    • Normal potassium levels, or they should be correctable with supplements.
    • Liver enzymes (AST and ALT) should be no more than 3 times the normal limit.
    • Total bilirubin (a liver function marker) should be no more than 1.5 times the normal limit.
    • Creatinine (a kidney function marker) should be no more than 1.5 times the normal limit, or your kidney filtration rate should be at least 50 mL/min.
    • Serum albumin (a protein in the blood) should be more than 3.5 g/dL.
    • Blood clotting tests (PT/INR and APTT) should be within normal range.
  • If you are a woman who is not postmenopausal or surgically sterile and are sexually active, you must agree to use effective birth control during the study and for 6 months after the last dose.
  • If you are a man with a partner who is not postmenopausal, you must agree to use a barrier method of birth control during the study and for 6 months after the last dose.
  • If you have type I diabetes, hypothyroidism needing hormone replacement, or certain skin conditions not needing systemic treatment, you can still participate.
  • You must be able to take oral medication.
  • You should be willing and able to follow the study visit schedule and other requirements.
  • You need a confirmed diagnosis of grade 2 or grade 3 meningioma, according to the WHO 2021 classification.
  • Your tumor should show growth or a new lesion on imaging tests within the last 6 months.
  • You should not be eligible for more surgery or radiotherapy.
  • You must have at least one measurable tumor lesion on an MRI scan.
  • Your performance status, which measures your ability to perform daily activities, should be 0 to 1 on the ECOG scale.
  • You must be 18 years of age or older.

Who Cannot Join the Study?

  • Patients who have not had surgery and radiotherapy for their meningioma.
  • Patients with other types of tumors or cancers, not specifically grade 2 or grade 3 meningioma.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients with severe medical conditions that could interfere with the study, such as uncontrolled high blood pressure or heart problems.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had an allergic reaction to the study medication or similar drugs in the past.
  • Patients with a history of drug or alcohol abuse that could affect their ability to participate in the study.
  • Patients who have received certain medications or treatments that could interfere with the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
IRCCS Humanitas Research Hospital Rozzano Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Bari Italy

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Azienda Sanitaria Locale Bari Bari Italy
Azienda Sanitaria Locale Napoli 1 Centro Naples Italy
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
IRCCS Ospedale Policlinico San Martino Genoa Italy
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Iorqfo Iugpfklw Fcxphgspuwgev Oavwbldyifw Rome Italy
Abuecsx Uzb Tgdqeqp nmal oufhg Leghorn Italy
Ixqfhejf Rojmicggl Prw Lp Swgycl Ddy Tncank Dbof Axbuwvy Ibna Saayoo Meldola Italy
Aunffoy Ofhxovotphk Udgemblhwjpwv Ckcwewjhnpag Dsylr Srcwuk E Dknee Swrpbew Dp Tthymr Turin Italy
Uvowtwyukq Dklaa Sushk Ds Rnak Lr Siosoozl Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
30.06.2024

Trial locations

Investigated drugs:

Regorafenib is a medication being studied for its potential to help people with certain types of brain tumors called grade 2 and grade 3 meningiomas. These tumors have come back or continued to grow after surgery and radiotherapy. The study is looking at whether Regorafenib can help stop the tumors from growing for a longer period.

Meningioma – Meningioma is a type of tumor that forms on the membranes covering the brain and spinal cord just inside the skull. It is typically classified into grades based on its growth rate and potential to spread. Grade 2 meningiomas are atypical, meaning they grow more quickly than benign tumors and may recur after treatment. Grade 3 meningiomas are malignant, growing rapidly and more likely to invade nearby tissues. These tumors can cause symptoms by pressing on the brain or spinal cord, leading to headaches, vision problems, or seizures. The progression of meningiomas can vary, with some remaining stable for years while others may grow and cause increasing symptoms.

Trial ID:
2024-510954-28-01
Protocol code:
MIRAGE
NCT ID:
NCT06275919
Trial Phase:
Therapeutic exploratory (Phase II)

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