regorafenib in patients with relapsed glioblastoma. iov-gb-1-2020 regoma-oss

Conditions: Glioblastoma Multiforme

Summary: 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".

the primary aim of the study

Eligibility criteria:
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)