LSTA1 for subjects with newly diagnosed Glioblastoma Multiforme when added to standard of care (temozolomide) versus temozolomide
Key facts
- Where
- Tallinn és Tartu Linn, ÉsztországSee the 2 sites
- Phase
- 2. fázis
Where in Észtország
- North Estonia Medical Centre FoundationTallinn, ÉsztországNo longer taking part
- Tartu University HospitalTartu Linn, ÉsztországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tartu University Hospital
- Trial code
- EU 2023-506813-23-00
- Record updated
- 2025. október 21.
- Original description
To determine the effect of LSTA1 in combination with TMZ on survival relative to matching LSTA1 placebo in combination with temozolomide in patients with newly diagnosed GBMRead full original descriptionShow less
A Phase 2, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating LSTA1 when added to standard of care (temozolomide) versus temozolomide and matching LSTA1 placebo in subjects with newly diagnosed Glioblastoma Multiforme (GBM)
To determine the effect of LSTA1 in combination with TMZ on survival relative to matching LSTA1 placebo in combination with temozolomide in patients with newly diagnosed GBM
Inclusion: Subjects must be ≥ 18 <76 years of age at time of screening and provide a written informed consent; Adequate respiratory and cardiac function (PaO2 ≥ 60 mm Hg or oxygen saturation ≥ 92% on room air, and 12-lead ECG with normal tracing or non-clinically significant changes that do not require medical intervention); Adequate contraception; Subjects must have newly diagnosed and histologically confirmed intracranial glioblastoma multiforme (GBM) according to the 2021 World Health Organization (WHO) Classification; Subjects must have undergone primary surgical resection for GBM followed by initial standard radiotherapy regimen (60Gy/30 fractions) in combination with temozolomide for 6 weeks; Subjects must have sufficient time for recovery from prior surgery (at least 4 weeks); Subjects must be able to undergo serial MRIs (computerized tomography may not be a substitute for magnetic resonance imaging [MRI]); Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2; Life expectancy ≥ 3 months, as determined by the investigator; Patient may have- or continue to receive corticosteroids, by s/he must be on a stable or decreasing dose for at least 14 days prior to randomization; Subjects must have adequate organ and marrow function.
Exclusion: Besides initial TMZ therapy, patients with prior cytotoxic or non-cytotoxic drug therapy or experimental drug therapy including chemotherapy, hormonal therapy, or immunotherapy for the brain tumor; Patients who received prior Gliadel wafers; Patients with concurrent stereotactic radiosurgery or brachytherapy; Progression of GBM during or after the standard-of-care radiotherapy and TMZ 6-week regimen; Patient has known hypersensitivity to temozolomide or compounds with similar chemical composition to temozolomide; Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent; Patients with extracranial metastatic disease; Subject has evidence of acute intracranial or intratumoral hemorrhage > Grade 1 by MRI. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin may enter the study; Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment; Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities; Patients with leptomeningeal dissemination; Participation in another interventional clinical study within the last 1 year.