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

February 7, 2024 updated by: Istituto Oncologico Veneto IRCCS

Regorafenib in Relapsed Glioblastoma. An Observational, Multicentric and Prospective Study. 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".

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary aim of the study

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
192

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 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
From the enrolment date to the date of death, for any cause, or to the last follow-up, assessed up to 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 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.
From the date of enrolment to the date of disease progression or to the date of death, assessed up to 18 months
Objective response rate (ORR)
Time Frame: Approximately 24 months
As percentage of patients achieving a complete response plus partial response
Approximately 24 months
Disease control rate (DCR)
Time Frame: Approximately 24 months
As percentage of patients achieving a complete response plus partial response plus stable disease.
Approximately 24 months
Toxicity (Graded according to the NCI-Common Terminology Criteria for Adverse Events-CTCAE v5.0)
Time Frame: 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
From the start of Regorafenib treatment up to 30 days after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Oncologico Veneto IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IOV-GB-1-2020 REGOMA-OSS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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