Actively Recruiting
5G-PEARL: Paxalisib in Malignant Brain Tumours
Led by Institute of Cancer Research, United Kingdom · Updated on 2026-02-05
64
Participants Needed
1
Research Sites
179 weeks
Total Duration
On this page
Sponsors
I
Institute of Cancer Research, United Kingdom
Lead Sponsor
M
Minderoo Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
5G-PEARL: Paxalisib in Malignant Brain Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 16 years or older
- Histologically confirmed advanced WHO Stage IV glioblastoma (including IDH-wildtype Grade 4 per 2021 WHO classification)
- Consent to the Minderoo Precision Brain Tumour Programme with available whole genome and transcriptome data
- Completion of optimal surgery and Stupp based chemoradiotherapy, starting study treatment within 6 weeks of chemoradiotherapy completion
- Radiologically stable without tumour progression after chemoradiotherapy
- Life expectancy of at least 12 weeks
- WHO performance status of 0-1
- Neurologically stable without progression or increasing steroid doses within one week prior to treatment
- Written informed consent and ability to cooperate with treatment and follow-up
- Haematological and biochemical parameters within specified ranges prior to first dose
- Female patients with reproductive potential must have a negative pregnancy test within 14 days before trial start
- Men and women of childbearing potential must agree to use highly effective contraception during the study and for 180 days after last dose
You will not qualify if you...
- Treatment with bevacizumab, investigational drugs, or tumour treating fields within specified intervals before study start
- Prior immune checkpoint inhibitor or vaccine therapy; other immune-modulatory agents require sponsor discussion
- Ongoing Grade 2 or higher toxicities from previous treatments or conditions
- Presence of carcinomatous meningitis, leptomeningeal spread, or tumour spread to brain stem or spinal cord
- Recent intratumoural or peritumoural haemorrhage on MRI unless stable on two scans
- History of significant bleeding disorders or arterial thromboembolism
- Recent deep vein thrombosis, pulmonary embolism, or significant thromboembolism within 3 months
- Significant cardiac disorders including recent myocardial infarction or heart failure, or abnormal ECG findings
- History of malabsorption syndromes or active inflammatory bowel disease
- Uncontrolled diabetes (controlled diabetes with HbA1C <8% allowed)
- Urine protein >1 g/24 hours
- Significant lung disease or history of opportunistic infections
- Positive serology for hepatitis B, hepatitis C, or HIV
- Steroid use above 3mg dexamethasone daily for neurological symptoms unless stable dose
- Live vaccines within 30 days prior to study; inactivated vaccines allowed with restrictions
- Active concurrent malignancy except those disease-free for 3 years or more
- Participation in other interventional clinical trials during this study
- Use of medications or supplements with potential drug interactions within 14 days before first dose
- Recent major surgery within 4 weeks or minor surgery within 2 weeks
- Live attenuated vaccines not permitted within 4 weeks before or during study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Royal Marden NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
5
5G Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here