OncoMatch/Clinical Trials/NCT07391215
5G-PEARL: Paxalisib in Malignant Brain Tumours
Is NCT07391215 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Paxalisib and Temozolomide capsule for malignant primary gliomas.
Treatment: Paxalisib · Temozolomide capsule — The purpose of this clinical trial is to evaluate the safety and tolerability of paxalisib in combination with temozolomide and to determine the preliminary antitumour activity of the combination therapy. In the Phase 1b of this study parallel biomarker defined arms will be opened in the front-line unmethylated MGMT setting, enrolling 10 patients onto each arm. These patients will be treated with paxalisib in combination with temozolomide (TMZ). The starting dose of paxalisib will be 45mg once a day (OD) with the option of increasing to 60 mg (30 mg BD) in Cycle 2. TMZ will be administered once daily by mouth on days 1 to 5 in a 28-day cycle, with a starting dose of 150mg/m2 during cycles 1 and 2, and subsequent dose escalation to 200mg/m2 at the start of cycle 3 if cycles 1 and 2 have been well tolerated with no significant toxicity.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
Disease stage
Required: Stage IV
Grade: 4 (who)
Performance status
WHO 0–1
Prior therapy
Must have received: surgery — frontline
completion of optimal surgery
Must have received: Stupp based adjuvant chemoradiotherapy — adjuvant
completion of optimal surgery and Stupp based adjuvant chemoradiotherapy
Cannot have received: bevacizumab (bevacizumab)
Bevacizumab during the prior 6 weeks
Cannot have received: tumour treating fields
Tumour treating fields during the prior 6 weeks
Cannot have received: immune checkpoint inhibitor
Prior immune checkpoint inhibitor therapy or vaccine therapy is not permitted
Cannot have received: investigational medicinal product
Any investigational medicinal product since diagnosis
Lab requirements
Blood counts
Haemoglobin (Hb): ≥ 9.0 g/dL. Absolute neutrophil count: ≥1.5 x 10^9/L. Platelet count: ≥100 x 10^9/L. Coagulation: INR < 1.5 and APTT <1.5x if not anticoagulated. INR stable > 7 days within intended therapeutic range if anticoagulated
Kidney function
Creatinine: <1.5 x ULN. Sodium: ≥130 mmol/L. Potassium, Calcium, Magnesium, phosphate: Within institution normal ranges (replacement is permitted)
Liver function
Bilirubin: ≤1.5 x ULN; participants with Gilbert's syndrome can enrol if conjugated bilirubin is within normal ranges. ALT and AST: <3 x ULN. Albumin: ≥ 28 g/L
Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week prior to the first dose of either IMP.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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