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

Sponsor

Istituto Oncologico Veneto IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT04810182

Collaborator

(none)

150

Enrollment

Locations

24.7

Anticipated Duration (Months)

5.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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".

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma Multiforme	Drug: Regorafenib 40 MG Oral Tablet [STIVARGA]

Detailed Description

The primary aim of the study

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 10, 2020

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Glioblastoma Patients treated with Regorafenib Patients with a confirmed diagnosis of Glioblastoma for whom a decision to treat with regorafenib has been made (by the treating physician).	Drug: Regorafenib 40 MG Oral Tablet [STIVARGA] As per the treating physicians discretion

Arm

Intervention/Treatment

Glioblastoma Patients treated with Regorafenib

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

Drug: Regorafenib 40 MG Oral Tablet [STIVARGA]

As per the treating physicians discretion

Outcome Measures

Primary Outcome Measures

Overall Survival (OS) [From the enrolment date to the date of death, for any cause, or to the last follow-up, assessed up to 18 months]
Overall Survival is defined as the time from date of enrolment to the date of death due to any cause

Secondary Outcome Measures

Progression free survival (PFS) [From the date of enrolment to the date of disease progression or to the date of death, assessed up to 18 months]
from the date of enrolment to the date of disease progression determined using RANO criteria or to the date of death, whichever occurs first.
Objective response rate (ORR) [Approximately 24 months]
As percentage of patients achieving a complete response plus partial response
Disease control rate (DCR) [Approximately 24 months]
As percentage of patients achieving a complete response plus partial response plus stable disease.
Toxicity (Graded according to the NCI-Common Terminology Criteria for Adverse Events-CTCAE v5.0) [From the start of Regorafenib treatment up to 30 days after the end of treatment]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ospedale Generale Regionale " F.Miulli "	Acquaviva Delle Fonti	BA	Italy	70021
2	Policlinico Universitario di Bari	Bari	BA	Italy	70124
3	IRCCS "Saverio de Bellis"	Castellana Grotte	BA	Italy	70013
4	Ospedlae S. Martino	Belluno	BL	Italy	32100
5	Ospedale Bellaria	Bologna	BO	Italy	40124
6	Ospedale Perrino	Brindisi	BR	Italy	72100
7	Università e ASST Spedali Civili	Brescia	BS	Italy	25123
8	Irst-Irccs	Meldola	FC	Italy	47014
9	Ospedale Santa Maria Annunziata	Bagno A Ripoli	FI	Italy	50012
10	Azienda Ospedaliera Universitaria Careggi	Firenze	FI	Italy	50134
11	Ospedale Civile di Livorno	Livorno	LO	Italy	57100 -
12	Ospedale Generale Provinciale	Macerata	MC	Italy	62100
13	AOU Policlinico "G.Martino"	Messina	ME	Italy	98122
14	Istituto Neurologico C. Besta IRCCS	Milano	MI	Italy	20133
15	Ospedale Humanitas	Rozzano	MI	Italy	20089
16	Ospedale del Mare	Napoli	NL	Italy	80145
17	Fondazione Istiuto Giglio Cefalù	Cefalù	PA	Italy	90015
18	Aulss6 Euganea Padova Sud Ospedali Riuniti	Piove Di Sacco	PD	Italy	35131
19	Azienda Ospedaliero Universitaria di Pisa	Pisa	PI	Italy	56126
20	Istituto Nazionale Tumori Regina Elena -IFO	Roma	RM	Italy	00144
21	Policlinico Universitario Gemelli	Roma	RM	Italy	00168
22	Ospedale di Rovigo	Rovigo	RO	Italy	45100
23	Azienda Ospedaliero Universitaria di Siena	Siena	SI	Italy	53100
24	Azienda Ospedaliero Universitaria della Città della Salute e della Scienza	Torino	TO	Italy	10126
25	Azienda Ospedaliera Santa Maria	Terni	TR	Italy	05100
26	Ospedale San Donà di Piave _Azienda ULSS 4 " Veneto Orientale"	San Dona di Piave	VE	Italy	30027
27	AULSS 7 Distretto 2 Ospedale Santorso	Santorso	VI	Italy	36014
28	AULSS 9 Scaligera Ospedale Mater Salutis	Legnago	VR	Italy	37045
29	Azienda Sanitaria Universitaria Friuli Centrale	Udine		Italy	33100

Sponsors and Collaborators

Istituto Oncologico Veneto IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Oncologico Veneto IRCCS

ClinicalTrials.gov Identifier:

NCT04810182

Other Study ID Numbers:

IOV-GB-1-2020 REGOMA-OSS

First Posted:

Mar 22, 2021

Last Update Posted:

Apr 1, 2022

Last Verified:

Mar 1, 2022

Additional relevant MeSH terms:

Glioblastoma

Study Results

No Results Posted as of Apr 1, 2022