Back to resultsBiomolecular Analysis for Predicting Response to Regorafenib (RegoRec)
Primary Purpose
Glioblastoma, Glioblastoma, IDH-wildtype
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Biomolecular tumor analysis
Sponsored by
About this trial
This is an interventional other trial for Glioblastoma focused on measuring regorafenib, NGS, predictive biomarker
Eligibility Criteria
Inclusion Criteria: recurrent glioblastoma after surgery and chemoradiation with temozolomide; indication to treatment with regorafenib per standard of care; written informed consent. Exclusion Criteria: None.
Sites / Locations
- Fondazione Policlinico Universitario A. Gemelli IRCCSRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Biomolecular tumor analysis
Arm Description
NGS, IHC, methylome and other molecular studies
Outcomes
Primary Outcome Measures
Overall survival
Secondary Outcome Measures
Full Information
NCT ID
NCT05759195
First Posted
February 23, 2023
Last Updated
March 6, 2023
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1. Study Identification
Unique Protocol Identification Number
NCT05759195
Brief Title
Biomolecular Analysis for Predicting Response to Regorafenib
Acronym
RegoRec
Official Title
Tumor Biomolecular Analysis for Defining Predictive Factors for Response to Regorafenib in Recurrent Glioblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study envisages NGS analysis on tumor tissue from patients treated with regorafenib for recurrent glioblastoma as per standard care, with the aim to identify predictive biomarkers for response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Glioblastoma, IDH-wildtype
Keywords
regorafenib, NGS, predictive biomarker
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Biomolecular tumor analysis
Arm Type
Other
Arm Description
NGS, IHC, methylome and other molecular studies
Intervention Type
Diagnostic Test
Intervention Name(s)
Biomolecular tumor analysis
Intervention Description
NGS analysis, other molecular analyses on FFPE tumor tissue
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
through study completion, an average of 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
recurrent glioblastoma after surgery and chemoradiation with temozolomide;
indication to treatment with regorafenib per standard of care;
written informed consent.
Exclusion Criteria:
None.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Q. Giorgio D'Alessandris, MD
Phone
+39 06 30155414
Email
quintinogiorgio.dalessandris@policlinicogemelli.it
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Chiesa, MD
Phone
+39 06 30151
Email
silvia.chiesa@policlinicogemelli.it
Facility Information:
Facility Name
Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Q. Giorgio D'Alessandris, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Biomolecular Analysis for Predicting Response to Regorafenib
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