Regorafenib in Patients With Relapsed Glioblastoma. IOV-GB-1-2020 REGOMA-OSS

Istituto Oncologico Veneto IRCCS

Status: Completed

Conditions: Glioblastoma Multiforme

Treatments: Drug: Regorafenib 40 MG Oral Tablet [STIVARGA]

Study type: Observational

Funder types: Other

Identifiers

NCT04810182

IOV-GB-1-2020 REGOMA-OSS

Details and patient eligibility

About

This study aims to analyze the role the of Regorafenib in prolonging the Overall Survival of glioblastoma multiforme patients who progressed after surgery and a first-line chemo-radiotherapy treatment in the setting of "real world life".

Full description

The primary aim of the study

Enrollment: 192 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female ≥ 18 years of age
• Histologically confirmed glioblastoma (grade IV)
• First recurrence after adjuvant treatment (surgery followed by radiotherapy and temozolomide chemotherapy) in patients who have not received further therapeutic interventions
• World Health Organization (WHO) Performance status ≤ 1 (or Karnofsky performance status (KPS) ≥70)) before the start of the treatment
• Documented progression of disease as defined by RANO criteria at least 12 weeks after completion of radiotherapy, unless the recurrence is outside the radiation field or has been histologically documented.
• Documented progression of disease by a brain MRI scan done within 14 days before the start of treatment with Regorafenib.
• Stable or decreasing dosage of steroids for 7 days prior to the baseline MRI scan.
• Have adequate bone marrow function, liver function, and renal function, as measured by the following laboratory assessments conducted within 7 days prior to the initiation of study treatment:
• Hemoglobin >9.0 g/dl
• Absolute neutrophil count (ANC) >1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors
• Platelet count ≥100,000/μl
• White blood cell count (WBC) >3.0 x 109/L
• Total bilirubin <1.5 times the upper limit of normal
• ALT and AST <3 x upper limit of normal
• Serum creatinine <1.5 x upper limit of normal
• Alkaline phosphatase <2.5 x ULN (<5 x upper limit of normal value)
• PT-INR/PTT <1.5 x upper limit of normal
• Lipase ≤ 1.5 x the ULN
• Glomerular filtration rate ≥ 30 mL/min/1.73 m2
• TSH, fT3,fT4 within normal limits
• Patients may have undergone surgery for the recurrence; the histological report must document a glioblastoma recurrence. If operated:
• at least 28 days from the surgery is required prior to Regorafenib administration and patients should have fully recovered.

Exclusion criteria

• Have had prior treatment with regorafenib or any other VEGFR-targeting kinase inhibitor
• Have had systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and/or hormonal therapy within 4 weeks prior to initiation of treatment
• Recurrent disease located outside of the brain
• Have uncontrolled hypertension (systolic blood pressure [SBP] > 140 mmHg or diastolic blood pressure [DBP] > 90 mmHg) despite optimal medical management
• Have had a myocardial infarction < 6 months prior to initiation of treatment with Regorafenib
• Have had arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within 6 months prior to the initiation of treatment with Regorafenib
• Have either active or chronic hepatitis B or C requiring treatment with antiviral therapy
• Are taking strong cytochrome P (CYP) CYP3A4 inhibitors (eg, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A4 inducers (eg, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort)

Trial design

192 participants in 1 patient group

Glioblastoma Patients treated with Regorafenib

Description:

Patients with a confirmed diagnosis of Glioblastoma for whom a decision to treat with regorafenib has been made (by the treating physician).

Treatment:

Drug: Regorafenib 40 MG Oral Tablet [STIVARGA]