Regorafenib in Bevacizumab Refractory Recurrent Glioblastoma

  • STATUS
    Recruiting
  • End date
    Feb 4, 2022
  • participants needed
    22
  • sponsor
    Case Comprehensive Cancer Center
Updated on 4 August 2021
cancer
corticosteroids
nitrosoureas
serum pregnancy test
karnofsky performance status
cytotoxic chemotherapy
neutrophil count
bevacizumab
carcinoma in situ
glioblastoma multiforme
temozolomide
gliosarcoma
malignant glioma

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. Even though a participant may meet all the criteria for participation, it is possible that they will not be enrolled in this study.

Details
Condition Recurrent Glioblastoma
Treatment Regorafenib
Clinical Study IdentifierNCT04051606
SponsorCase Comprehensive Cancer Center
Last Modified on4 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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
weeks since last non-cytotoxic therapy
weeks must have elapsed since the completion of a non-nitrosourea containing chemotherapy regimen
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

Exclusion Criteria

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)
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])
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