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Recurrent GlioblastomaPhase 2NCT04051606

Regorafenib in Bevacizumab Refractory Recurrent Glioblastoma

A Phase 2 study testing Regorafenib in people with Recurrent Glioblastoma, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Glioblastoma
What is being tested?
Regorafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
31 Jul 2019to 20 Mar 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The participant (or legally representative if applicable) provides written informed consent for the trial.
  • Patients with histologically confirmed glioblastoma or other grade IV malignant glioma (i.e. gliosarcoma, small cell glioblastoma, etc.), recurrent after prior external-beam fractionated radiotherapy and temozolomide chemotherapy.
  • Patients with documented radiographic progression following bevacizumab therapy for treatment of glioblastoma
  • Patients with up to 3 prior recurrences are allowed (patients could have received bevacizumab or bevacizumab containing regimen either in first or second recurrence).
  • Karnofsky performance status ≥ 70%.
  • Patients must have the following laboratory values:
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  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelets ≥ 100 x 109/L
  • Hemoglobin (Hgb) > 9 g/dL
  • Serum total bilirubin: ≤ 1.5 x ULN
  • ALT and AST ≤ 3.0 x ULN
  • Serum creatinine ≤ 1.5 x ULN
  • Blood coagulation parameters: INR ≤ 1.5
  • Minimum interval since completion of radiation treatment is 12 weeks
  • Minimum interval since last drug therapy:
  • 3 weeks since last non-cytotoxic therapy
  • 3 weeks must have elapsed since the completion of a non-nitrosourea containing chemotherapy regimen
  • 6 weeks since the completion of a nitrosourea containing chemotherapy regimen.
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test. The definition of adequate contraception will be based on the judgment of the investigator.
  • Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least2 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
  • Patients must have no concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix and breast, adequately treated stage I or II cancer from which the patient is in complete remission. Patients with other prior malignancies must be disease-free for ≥ three years.
  • Patients must be maintained on a stable or decreasing corticosteroid regimen from the time of their baseline scan until the start of treatment and/or for at least 5 days before starting treatment. The maximum dosing of corticosteroid therapy is 4mg/day.
  • Life expectancy of at least 12 weeks (3 months).
  • Subject must be able to swallow and retain oral medication.

Who cannot join

  • Patients who have had previous treatment with Regorafenib
  • Patients who have undergone major surgery (e.g. intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 4 weeks prior to starting study drug, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to starting study drug, or who have not recovered from side effects of such procedure or injury
  • Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
  • Congestive heart failure - New York Heart Association (NYHA) > Class II
  • History or presence of serious uncontrolled ventricular arrhythmias. Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
  • Clinically significant resting bradycardia (defined as bradycardia that required intervention)
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  • Active coronary artery disease defined as Any of the following within 6 months prior to starting study drug: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG)
  • Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE) in the last 6 months
  • Uncontrolled hypertension (defined by a SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg despite anti-hypertensive medications)
  • Patients with cirrhosis, or active viral or nonviral hepatitis.
  • Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)
  • Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection, uncontrolled diabetes) that could cause unacceptable safety risks or compromise compliance with the protocol
  • Pregnant or breast-feeding women
  • Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human, chimeric, or humanized antibodies
  • Patients with active bleeding or pathologic conditions that carry a high risk of bleeding, (i.e. hereditary hemorrhagic telangiectasia).
  • Patients who are currently receiving anticoagulation treatment (warfarin is not allowed, low weight heparin is allowed). Evidence or history of bleeding diathesis or coagulopathy.
  • Patients unwilling or unable to comply with the protocol
  • Any hemorrhage or bleeding event ≥ NCI CTCAE v5.0 Grade 3 within 4 weeks prior to start of study medication.
  • Patients with phaeochromocytoma.
  • Ongoing infection > Grade 2 NCI-CTCAE v5.0.
  • Presence of a non-healing wound, non-healing ulcer, or bone fracture.
  • Persistent proteinuria ≥ Grade 3 NCI-CTCAE v5.0 (> 3.5 g/24 hrs, measured by urine protein: creatinine ratio on a random urine sample).
  • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
  • Pleural effusion or ascites that causes respiratory compromise (≥ NCI-CTCAE version 5.0 Grade 2 dyspnea).
  • Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial.
  • Any malabsorption condition.
  • Women who are pregnant or breast-feeding.
  • Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
  • Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
  • Excluded therapies and medications, previous and concomitant
  • Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment (regorafenib, other agents being investigated in combination with regorafenib).
  • Prior use of regorafenib.
  • Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form).
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication.
  • Therapeutic anticoagulation with Vitamin-K antagonists (e.g., warfarin)
  • Use of any herbal remedy (e.g. St. John's wort [Hypericum perforatum]).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

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.

Being tested
Regorafenib
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RegorafenibDrug

    Regorafenib is a monotherapy during the study, oral administration at 160 mg once daily will be administered for 3 weeks on /1 week off.

Study groups in NCT04051606
Study groupRoleWhat they receive
RegorafenibExperimental160 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.
Receives: Drug: Regorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median overall survival (OS)

    Median overall survival (OS) in patients with recurrent or progressive GBM who have progressed on bevacizumab.

    Measured: Up to 3 years from start of treatment

Secondary outcomes (4)

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Safety and tolerability of regorafenib by CTCAE version 5.0. Safety and tolerability will be defined by the percent of participants experiencing >= grade 3 AE/SAE

    Measured: Up to 3 years from start of treatment

  2. Objective response rate (ORR)

    ORR by modified RANO criteria. ORR defined by modified RANO criteria . The percentage of patients that have at least 50% reduction in their tumor size in 2 dimensions.

    Measured: Up to 3 years from start of treatment

  3. Progression free survival at 6 months (PFS-6).

    Survival and absence of progressive disease at 6 months, with progression defined as >25% in the sum of products of the perpendicular diameters of CE lesions; evidence of new lesion(s).

    Measured: at 6 months from start of treatment

  4. Median time to progression (TTP)

    Time that takes a median patient to progress defined as >25% in the sum of products of the perpendicular diameters of CE lesions; evidence of new lesion(s).

    Measured: Up to 3 years from start of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2019
  2. Study start31 Jul 2019
  3. Primary completion20 Mar 2024
  4. Study completion20 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04051606
Sponsor's protocol ID
CASE7318
Status last verified
Jun 2025
First submitted
7 Aug 2019
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Will share main findings of the clinical study report (CSR)

Publications

  • Lucas A, Peereboom D, Rauf Y, Li H, Hanlon J, Ahluwalia M. Phase 2 study of regorafenib in patients with progressive glioblastoma after failure of bevacizumab. Neurooncol Adv. 2026 Jun 9;8(1):vdag144. doi: 10.1093/noajnl/vdag144. eCollection 2026 Jan-Dec.

    PubMed 42325608

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Regorafenib in people with Recurrent Glioblastoma, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median overall survival (OS) (time frame: Up to 3 years from start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04051606, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.

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