Trial · NCT07391215
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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). |
| 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 20-item European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Brain Neoplasm module (EORTC QLQ-BN20) (Baseline, end of C1, C3D1) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT07391215/registered