Trial · NCT07391215
5G-PEARL: Paxalisib in Malignant Brain Tumours
NCT07391215, Phase 1, Phase 2, Recruiting, Institute of Cancer Research, United Kingdom
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 5G-PEARL: Paxalisib in Malignant Brain Tumours. Trials, record NCT07391215. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07391215
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 5G-PEARL: Paxalisib in Malignant Brain Tumours
- NCT number
- NCT07391215
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 64 participants, estimated
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Conditions
- Malignant Primary Gliomas, Glioblastoma Multiforme (GBM)
- Interventions
- Paxalisib, Temozolomide capsule
- First posted
- 2026-02-05
- Last updated
- 2026-02-05
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1b - Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) in patients with malignant brain tumours | 12 months | To identify the incidence, nature and severity of adverse events and laboratory abnormalities, with severity determined according to NCI CTCAE v5.0 |
| Primary | Phase 1b - To determine the preliminary antitumour activity of the investigational agent administered at the RP2D in patients with molecularly defined malignant brain tumours | 12 months | Antitumour activity will be defined on the basis of the following outcomes. If any of the following occur, patients will be considered to have clinically benefitted: For front line unmethylated GBM (MRD): • Progression-free survival (PFS) |
| Primary | Phase 2 - To determine the antitumour activity of investigational agent administered at the RP2D in patients with molecularly defined malignant brain tumours | 24 months | Antitumour activity will be defined on the basis of the following outcome: • Progression-free survival (PFS), defined as the time from enrolment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RANO |
| Primary | Phase 2 - To determine the antitumour activity of investigational agent administered at the RP2D in patients with molecularly defined malignant brain tumours | 24 months | Antitumour activity will be defined on the basis of the following outcome: Overall survival (OS), defined as the time from enrolment to death from any cause |
| Secondary | Phase 1b - To identify genetic biomarkers of response in patients with molecularly selected brain tumours | 12 months | Determine co-occurring genetic biomarkers predicting response. |
| Secondary | Phase 2 - To identify genetic biomarkers of response in patients with molecularly selected brain tumours. | 24 months | Determine co-occurring genetic biomarkers predicting response. |
| Secondary | Phase 2 - To assess changes in Quality of Life over time | 12 months | OS12, defined as the percentage of patients who remained free of death at 12 months from study enrolment |
| Secondary | Phase 2 - To assess changes in Quality of Life over time | 6 months | PFS6, defined as the percentage of patients who remained free of disease progression 6 months from study enrolment |
| Secondary | Phase 2 - Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of combination with TMZ when given as standard of care maintenance therapy | 24 months | To identify the incidence, nature and severity of adverse events and laboratory abnormalities, with severity determined according to NCI CTCAE v5.0 |
| Secondary | Phase 2 - To assess changes in Quality of Life over time | 24 months | Global changes over time in health-related quality of life (HRQOL) as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) (Baseline, end of C1, C3D1). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07391215
GET https://conductscience.org/api/trials/v1/NCT07391215/registered