Regorafenib in Relapsed Glioblastoma. An Observational, Multicentric and Prospective Study. IOV-GB-1-2020 REGOMA-OSS

IOV-GB-1-2020 REGOMA-OSS

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".

2020-09-10

2023-12-31

2023-12-31

Completed

192

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)

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 192, 'type': 'ACTUAL'}}

2024-02-08