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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04810182
• Other study ID #: IOV-GB-1-2020 REGOMA-OSS
• Status: Completed
• Start date: September 10, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: Istituto Oncologico Veneto IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

Description:

The primary aim of the study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• Regorafenib 40 MG Oral Tablet [STIVARGA]
As per the treating physicians discretion

Locations

Country	Name	City	State
Italy	Ospedale Generale Regionale " F.Miulli "	Acquaviva Delle Fonti	BA
Italy	Ospedale Santa Maria Annunziata	Bagno A Ripoli	FI
Italy	Policlinico Universitario di Bari	Bari	BA
Italy	Ospedlae S. Martino	Belluno	BL
Italy	Ospedale Bellaria	Bologna	BO
Italy	Università e ASST Spedali Civili	Brescia	BS
Italy	Ospedale Perrino	Brindisi	BR
Italy	IRCCS "Saverio de Bellis"	Castellana Grotte	BA
Italy	Fondazione Istiuto Giglio Cefalù	Cefalù	PA
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze	FI
Italy	AULSS 9 Scaligera Ospedale Mater Salutis	Legnago	VR
Italy	Ospedale Civile di Livorno	Livorno	LO
Italy	Ospedale Generale Provinciale	Macerata	MC
Italy	Irst-Irccs	Meldola	FC
Italy	AOU Policlinico "G.Martino"	Messina	ME
Italy	Istituto Neurologico C. Besta IRCCS	Milano	MI
Italy	Ospedale del Mare	Napoli	NL
Italy	Aulss6 Euganea Padova Sud Ospedali Riuniti	Piove Di Sacco	PD
Italy	Azienda Ospedaliero Universitaria di Pisa	Pisa	PI
Italy	Istituto Nazionale Tumori Regina Elena -IFO	Roma	RM
Italy	Policlinico Universitario Gemelli	Roma	RM
Italy	Ospedale di Rovigo	Rovigo	RO
Italy	Ospedale Humanitas	Rozzano	MI
Italy	Ospedale San Donà di Piave _Azienda ULSS 4 " Veneto Orientale"	San Dona di Piave	VE
Italy	AULSS 7 Distretto 2 Ospedale Santorso	Santorso	VI
Italy	Azienda Ospedaliero Universitaria di Siena	Siena	SI
Italy	Azienda Ospedaliera Santa Maria	Terni	TR
Italy	Azienda Ospedaliero Universitaria della Città della Salute e della Scienza	Torino	TO
Italy	Azienda Sanitaria Universitaria Friuli Centrale	Udine

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Oncologico Veneto IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	Overall Survival is defined as the time from date of enrolment to the date of death due to any cause	From the enrolment date to the date of death, for any cause, or to the last follow-up, assessed up to 18 months
Secondary	Progression free survival (PFS)	from the date of enrolment to the date of disease progression determined using RANO criteria or to the date of death, whichever occurs first.	From the date of enrolment to the date of disease progression or to the date of death, assessed up to 18 months
Secondary	Objective response rate (ORR)	As percentage of patients achieving a complete response plus partial response	Approximately 24 months
Secondary	Disease control rate (DCR)	As percentage of patients achieving a complete response plus partial response plus stable disease.	Approximately 24 months
Secondary	Toxicity (Graded according to the NCI-Common Terminology Criteria for Adverse Events-CTCAE v5.0)	Toxicity during the treatment will be recorded and graded according to the NCICommon Terminology Criteria for Adverse Events (CTCAE) v.4.. , related to severity of the adverse event from Grade 1 to Grade 5	From the start of Regorafenib treatment up to 30 days after the end of treatment