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5G-PEARL: Paxalisib in Malignant Brain Tumours

NCT07391215 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-02-05

No results posted yet for this study

Summary

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

  • Malignant Primary Gliomas
  • Glioblastoma Multiforme (GBM)

Interventions

DRUG

Paxalisib

Supplied as 15 mg capsules (35 capsules per bottle).

DRUG

Temozolomide capsule

Temozolomide will be supplied as 5, 20, 100, 140, 180 or 250 mg hard capsules.

Sponsors & Collaborators

  • Minderoo Foundation

    collaborator UNKNOWN

  • Kazia Therapeutics Limited

    collaborator INDUSTRY

  • Royal Marsden NHS Foundation Trust

    collaborator OTHER

  • Cambridge University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Cancer Research UK

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Juanita Lopez, MD, PhD · National Health Service, United Kingdom

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-19
Primary Completion
2029-01-19
Completion
2029-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07391215 on ClinicalTrials.gov