Clinical trial NCT04810182: Regorafenib in Patients With Relapsed Glioblastoma. IOV-GB-1-2020 REGOMA-OSS
Official title: Regorafenib in Relapsed Glioblastoma. An Observational, Multicentric and Prospective Study. IOV-GB-1-2020 REGOMA-OSS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma Multiforme
Lead sponsor: Istituto Oncologico Veneto IRCCS
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with relapse of glioblastoma (grade IV) after surgery and radio-chemotherapy first line treatment, treated with Regorafenib until disease progression or the appearance of unacceptable toxicity.

Brief 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".

Detailed description: 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)

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: From the enrolment date to the date of death, for any cause, or to the last follow-up, assessed up to 18 months
Secondary outcomes:
measure: Progression free survival (PFS)
timeFrame: From the date of enrolment to the date of disease progression or to the date of death, assessed up to 18 months
measure: Objective response rate (ORR)
timeFrame: Approximately 24 months
measure: Disease control rate (DCR)
timeFrame: Approximately 24 months
measure: Toxicity (Graded according to the NCI-Common Terminology Criteria for Adverse Events-CTCAE v5.0)
timeFrame: From the start of Regorafenib treatment up to 30 days after the end of treatment
Other outcomes:
Locations:
city: Acquaviva Delle Fonti
country: Italy
facility: Ospedale Generale Regionale " F.Miulli "
state: BA
city: Bari
country: Italy
facility: Policlinico Universitario di Bari
state: BA
city: Castellana Grotte
country: Italy
facility: IRCCS "Saverio de Bellis"
state: BA
city: Belluno
country: Italy
facility: Ospedlae S. Martino
state: BL
city: Bologna
country: Italy
facility: Ospedale Bellaria
state: BO
city: Brindisi
country: Italy
facility: Ospedale Perrino
state: BR
city: Brescia
country: Italy
facility: Università e ASST Spedali Civili
state: BS
city: Meldola
country: Italy
facility: Irst-Irccs
state: FC
city: Bagno A Ripoli
country: Italy
facility: Ospedale Santa Maria Annunziata
state: FI
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: FI
city: Livorno
country: Italy
facility: Ospedale Civile di Livorno
state: LO
city: Macerata
country: Italy
facility: Ospedale Generale Provinciale
state: MC
city: Messina
country: Italy
facility: AOU Policlinico "G.Martino"
state: ME
city: Milano
country: Italy
facility: Istituto Neurologico C. Besta IRCCS
state: MI
city: Rozzano
country: Italy
facility: Ospedale Humanitas
state: MI
city: Napoli
country: Italy
facility: Ospedale del Mare
state: NL
city: Cefalù
country: Italy
facility: Fondazione Istiuto Giglio Cefalù
state: PA
city: Piove Di Sacco
country: Italy
facility: Aulss6 Euganea Padova Sud Ospedali Riuniti
state: PD
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria di Pisa
state: PI
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena -IFO
state: RM
city: Roma
country: Italy
facility: Policlinico Universitario Gemelli
state: RM
city: Rovigo
country: Italy
facility: Ospedale di Rovigo
state: RO
city: Siena
country: Italy
facility: Azienda Ospedaliero Universitaria di Siena
state: SI
city: Torino
country: Italy
facility: Azienda Ospedaliero Universitaria della Città della Salute e della Scienza
state: TO
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria
state: TR
city: San Dona di Piave
country: Italy
facility: Ospedale San Donà di Piave _Azienda ULSS 4 " Veneto Orientale"
state: VE
city: Santorso
country: Italy
facility: AULSS 7 Distretto 2 Ospedale Santorso
state: VI
city: Legnago
country: Italy
facility: AULSS 9 Scaligera Ospedale Mater Salutis
state: VR
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale
Study officials:
References: