JOURNAL ONKOLOGIE – STUDIE
GLORIA Glioblastoma Treatment With Irradiation and Olaptesed Pegol (NOX-A12) in MGMT Unmethylated Patients
Rekrutierend
NCT-Nummer:
NCT04121455
Studienbeginn:
September 2019
Letztes Update:
03.03.2021
Wirkstoff:
Olaptesed pegol
Indikation (Clinical Trials):
Glioblastoma
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
NOXXON Pharma AG
Collaborator:
-
Kontakt
Kontakt:
Phone: +49 30 72 62 47
Phone (ext.): 100
E-Mail: clinicaltrialdisclosuredesk@noxxon.com» Kontaktdaten anzeigen
Studienlocations (3 von 3)
Klinik und Poliklinik für Neurologie Schwerpunkt Klinische Neuroonkologie
Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-MapsKlinik für Neurologie
Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-MapsKlinik für Strahlentherapie und Radioonkologie
Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-MapsKlinik für Neurologie
Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-MapsKlinik für Strahlentherapie und Radioonkologie
Mannheim
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Studien-Informationen
Brief Summary:The purpose of this study is to obtain first, exploratory information on the safety and
efficacy of olaptesed pegol in combination with radiation therapy in patients with newly
diagnosed glioblastoma of unmethylated MGMT promoter status either not amenable to resection
(biopsy only) or after incomplete tumor resection.
Ein-/Ausschlusskriterien
Inclusion Criteria:1. Written informed consent
2. Age ≥18 years
3. Patient agreement to diagnostic and scientific work-up of glioblastoma tissue obtained
during the preceding surgery or biopsy
4. Patient agrees to subcutaneous port implantation
5. Newly diagnosed, histologically confirmed, supratentorial WHO grade IV glioblastoma
6. Status post biopsy or incomplete resection
7. Unmethylated MGMT promoter status
8. Maximum Eastern Cooperative Oncology Group (ECOG) score 2
9. Estimated minimum life expectancy 3 months
10. Stable or decreasing dose of corticosteroids during the week prior to inclusion
11. The following laboratory parameters should be within the ranges specified:
- Total bilirubin ≤ 1.5 x upper limit normal (ULN)
- Creatinine ≤ 1.5 x ULN or glomerular filtration rate ≥ 60 mL/min/1.73m²
- ALT (alanine transaminase) ≤ 3 x ULN
- AST (aspartate transaminase) ≤ 3 x ULN
12. Female patients of child-bearing potential must have a negative serum pregnancy test
within 21 days prior to enrollment and agree to use a highly effective method of birth
control (failure rate less than 1% per year when used consistently and correctly such
as contraceptive implants, vaginal rings, sterilization, or sexual abstinence)" during
and for 3 months following last dose of drug (more frequent pregnancy tests may be
conducted if required per local regulations)
13. Male patients must use an effective barrier method of contraception during study and
for 3 months following the last dose if sexually active with a FCBP
Exclusion Criteria:
1. Inability to understand and collaborate throughout the study or inability or
unwillingness to comply with study requirements
2. Participation in any clinical research study with administration of an investigational
drug or therapy within 30 days from screening visit or observation period of competing
studies
3. Contra-indication or known hypersensitivity to MRI contrast agents, olaptesed pegol or
polyethylene glycol
4. Cytostatic therapy (chemotherapy) within the past 5 years
5. History of other cancers (except for adequately treated basal or squamous cell skin
cancer, in situ cervical cancer, or other cancer from which the patient was
disease-free for ≥ 5 years)
6. Clinically significant or uncontrolled cardiovascular disease
7. Prior radiotherapy to the head
8. Any other previous or concomitant experimental glioblastoma treatments
9. Placement of Gliadel® wafer, seeds, or ferromagnetic nanoparticles
10. Pregnancy or lactation
11. Uncontrolled intercurrent illness; patients must be free of any clinically relevant
disease (other than glioma) that would, in the treating investigator's opinion,
interfere with the conduct of the study or study evaluations
12. Treatment not initiated within 6 weeks after first biopsy or surgery of glioblastoma
13. Prior enrolment into this study
Studien-Rationale
Primary outcome:1. Safety - Number of patients with treatment-related adverse events as assessed by CTCAE (Time Frame - 26 weeks):
Number of patients with treatment-related adverse events as assessed by CTCAE
Secondary outcome:
1. Efficacy - progression free survival at 6 months (PFS-6) (Time Frame - 6 months):
Progression free survival at 6 months (PFS-6) in %
2. Efficacy - Median progression-free survival (mPFS) (Time Frame - 24 months):
Median progression-free survival (mPFS) in months
3. Efficacy - Median overall survival (mOS) (Time Frame - 24 months):
Median overall survival (mOS) in months
4. Efficacy - Tumor vascularization as per vascular MRI (Time Frame - 24 months):
Changes from baseline in tumor vascularization over time as %cerebral blood volume
5. Plasma level of olaptesed pegol (Time Frame - 26 weeks):
concentration of olaptesed pegol in plasma in µmol/L
6. Quality of Life (QoL) EORTC QLQ-C30 Module (Time Frame - 24 months):
Quality of Life measures are recorded according to EORTC QLQ30 module, which is validated for cancer patients in general and measured as a unit of scale. This is a standard tool for assessing patient reported quality of Life along time during treatment.
7. Quality of Life (QoL) EORTC QLQ BN-20 Module (Time Frame - 24 months):
Quality of Life measures are recorded according to EORTC QLQ BN-20 module, which is validated for brain tumor patients and measured as a unit of scale. This is a standard tool for assessing patient reported quality of Life along time during treatment.
8. Neurologic functions as measured by the NANO scale (Time Frame - 24 months):
Change from baseline in neurologic performance scores by Neurologic Assessment in Neuro-Oncology (NANO) scale as an objective and quantifiable metric of neurologic function evaluable during a routine office examination. The NANO Scale evaluates 9 major domains of neurologic function, with each domain being scored on a range from 0 to 2 or 3.
Studien-Arme
- Experimental: 200 mg Olaptesed pegol + Radiotherapy
olaptesed pegol weekly for 26 weeks administered i.v. by continuous infusion plus radiotherapy during weeks 1-6 - Experimental: 400 mg Olaptesed pegol + Radiotherapy
olaptesed pegol weekly for 26 weeks administered i.v. by continuous infusion plus radiotherapy during weeks 1-6 - Experimental: 600 mg Olaptesed pegol + Radiotherapy
olaptesed pegol weekly for 26 weeks administered i.v. by continuous infusion plus radiotherapy during weeks 1-6
Geprüfte Regime
- Olaptesed pegol:
Olaptesed pegol continuous administration for 26 weeks - Radiotherapy:
Radiotherapy in weeks 1-6; cumulative dose of 60 Gy in 2 Gy fractions
Quelle: ClinicalTrials.gov
