Glioblastoma MultiformeNCT04810182
Regorafenib in Patients With Relapsed Glioblastoma. IOV-GB-1-2020 REGOMA-OSS
An observational study of Glioblastoma Multiforme, run by Istituto Oncologico Veneto IRCCS at 29 sites in Italy.
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". Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Regorafenib 40 MG Oral Tablet [STIVARGA]
- Type of treatment
- Pill or oral medicine
- How many people
- 192 participants
- Where
- 29 sitesItaly
- Study dates
- 10 Sep 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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)
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Italy29 sites
Ospedale Generale Regionale " F.Miulli "
Acquaviva delle Fonti, BA, 70021
Ospedale Santa Maria Annunziata
Bagno a Ripoli, FI, 50012
Policlinico Universitario di Bari
Bari, BA, 70124
Ospedlae S. Martino
Belluno, BL, 32100
Ospedale Bellaria
Bologna, BO, 40124
Università e ASST Spedali Civili
Brescia, BS, 25123
Ospedale Perrino
Brindisi, BR, 72100
IRCCS "Saverio de Bellis"
Castellana Grotte, BA, 70013
Fondazione Istiuto Giglio Cefalù
Cefalù, PA, 90015
Azienda Ospedaliera Universitaria Careggi
Florence, FI, 50134
AULSS 9 Scaligera Ospedale Mater Salutis
Legnago, VR, 37045
Ospedale Civile di Livorno
Livorno, LO, 57100 -
Irst-Irccs
Meldola, FC, 47014
AOU Policlinico "G.Martino"
Messina, ME, 98122
Istituto Neurologico C. Besta IRCCS
Milan, MI, 20133
Ospedale del Mare
Naples, NL, 80145
Aulss6 Euganea Padova Sud Ospedali Riuniti
Piove di Sacco, PD, 35131
Azienda Ospedaliero Universitaria di Pisa
Pisa, PI, 56126
Ospedale Generale Provinciale
Province of Macerata, MC, 62100
Istituto Nazionale Tumori Regina Elena -IFO
Roma, RM, 00144
Policlinico Universitario Gemelli
Roma, RM, 00168
Ospedale di Rovigo
Rovigo, RO, 45100
Ospedale Humanitas
Rozzano, MI, 20089
Ospedale San Donà di Piave _Azienda ULSS 4 " Veneto Orientale"
San Donà di Piave, VE, 30027
AULSS 7 Distretto 2 Ospedale Santorso
Santorso, VI, 36014
Azienda Ospedaliero Universitaria di Siena
Siena, SI, 53100
Azienda Ospedaliera Santa Maria
Terni, TR, 05100
Azienda Ospedaliero Universitaria della Città della Salute e della Scienza
Torino, TO, 10126
Azienda Sanitaria Universitaria Friuli Centrale
Udine, 33100
About this study
Official title: 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".
Read the detailed description
The primary aim of the study
- Conditions
- Glioblastoma Multiforme
- Being tested
- Regorafenib 40 MG Oral Tablet [STIVARGA]
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib 40 MG Oral Tablet [STIVARGA]Drug
As per the treating physicians discretion
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Regorafenib 40 MG Oral Tablet [STIVARGA] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall Survival is defined as the time from date of enrolment to the date of death due to any cause
Measured: 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 (4)
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.
Measured: 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)
As percentage of patients achieving a complete response plus partial response
Measured: Approximately 24 months
Disease control rate (DCR)
As percentage of patients achieving a complete response plus partial response plus stable disease.
Measured: Approximately 24 months
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
Measured: From the start of Regorafenib treatment up to 30 days after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start10 Sep 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810182
- Sponsor's protocol ID
- IOV-GB-1-2020 REGOMA-OSS
- Status last verified
- Feb 2024
- First submitted
- 15 Mar 2021
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regorafenib in Relapsed Glioblastoma. An Observational, Multicentric and Prospective Study. IOV-GB-1-2020 REGOMA-OSS
- ClinicalTrials.gov ID
- NCT04810182
- Acronym / sponsor ID
- IOV-GB-1-2020 REGOMA-OSS
- Conditions
- Glioblastoma Multiforme
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glioblastoma Patients treated with Regorafenib | – | Drug: Regorafenib 40 MG Oral Tablet [STIVARGA]Patients with a confirmed diagnosis of Glioblastoma for whom a decision to treat with regorafenib has been made (by the treating physician). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regorafenib 40 MG Oral Tablet [STIVARGA]As per the treating physicians discretion | Drug | Glioblastoma Patients treated with Regorafenib |
Primary outcome
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
4 secondary outcomes
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
Objective response rate (ORR)
Time frame: Approximately 24 months
Disease control rate (DCR)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma Multiforme, run by Istituto Oncologico Veneto IRCCS at 29 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.