Regorafenib for Glioblastoma

Overseen By David Peereboom, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Anticoagulants, Herbal remedies

Disqualifiers: Cardiac disease, Hypertension, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: Up to 3 years

14 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the safety and tolerability of Regorafenib in patients with recurrent or progressive glioblastoma (GBM) who have progressed on bevacizumab. Regorafenib is FDA approved administered as monotherapy during the study. 22 total patients are expected to participate in this study. Even though a participant may meet all the criteria for participation, it is possible that they will not be enrolled in this study.

Research Team

David Peereboom, MD

Principal Investigator

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Eligibility Criteria

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

I am not receiving any cancer treatments other than the study treatment.

It has been over 3 weeks since my last non-nitrosourea chemotherapy.

I have been on a stable or decreasing dose of corticosteroids, not exceeding 4mg/day.

Exclusion Criteria

I am on blood thinners, but not warfarin, and have no history of bleeding disorders.

I have been treated with Regorafenib before.

I haven't had major surgery or significant injury in the last 4 weeks, or minor procedures in the last week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 160 mg regorafenib 3 weeks on/one week off until progression or toxicity

Up to 3 years

MRI every 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Treatment Details

Interventions

• Regorafenib

Trial Overview The study tests the safety and tolerability of Regorafenib, an FDA-approved drug, in patients with glioblastoma that has recurred after prior treatments including chemotherapy and radiotherapy. The trial will involve up to 22 participants who meet strict eligibility criteria.

Participant Groups

Group I: Regorafenib Experimental Treatment 1 Intervention

160 mg regorafenib 3 weeks on/ one week off in participants with Avastin refractory Glioblastoma, continued until progression or toxicity. Participants will receive an MRI every 8 weeks.

Regorafenib is already approved in United States, European Union for the following indications:

Approved in United States as Stivarga for:

• Metastatic colorectal cancer
• Gastrointestinal stromal tumors (GIST)
• Hepatocellular carcinoma (HCC)

Approved in European Union as Stivarga for:

• Metastatic colorectal cancer
• Gastrointestinal stromal tumors (GIST)
• Hepatocellular carcinoma (HCC)

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+