Trial · NCT05929495
Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma
NCT05929495, Phase 2, Recruiting, University of Milano Bicocca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma. Trials, record NCT05929495. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05929495
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2, Open-label, Single-arm Study on the Use of Metformin as Adjunctive Therapy in High-grade Glioma
- NCT number
- NCT05929495
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 25 participants, estimated
- Lead sponsor
- University of Milano Bicocca
- Conditions
- Glioblastoma, IDH-wildtype, Metformin, Malignancies
- Interventions
- Metformin
- First posted
- 2023-07-03
- Last updated
- 2025-07-25
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Value of PFS at 6 months after the start of treatment | Frome baseline to 6 months | It allow us to determine the efficacy at the recommended dose (RD) of metformin in patients with GBM |
| Secondary | EORTC QLQ-C30 questionnaire at 6 months after the start of treatment | Frome baseline to 6 months | The Quality of Life of Cancer Patients questionnaire allow us to evaluate the change in the level of health-related quality of life. It consists of several questions that the patient must answer by choosing a value from 1 (minimum) to 4/7 (maximum), depending on the question. |
| Secondary | MMSE questionnaire at 6 months after the start of treatment | Frome baseline to 6 months | The Mini Mental State Evaluation questionnaire allow us to evaluate the change in the level of health-related quality of life. It consists of several questions for the patient to answer, but there are no minimum or maximum values for the patient to choose from. |
| Secondary | Safety and tolerability assessment of treatment | From baseline through study completion, an average of 32 months | Safety will be assessed throughout the study as type, frequency and severity of grade III and IV events. Tolerability will be assessed as number of discontinuations or dose reduction and by evaluation of clinical and hematochemical parameters |
| Secondary | Plasma measurement of circulating metabolites | At study completion, an average of 32 months | Peri-operative plasma will be taken from each patient for hematochemical analysis, in order to research of prognostic biomarkers. |
| Secondary | Plasma measurement of adiponectin | At study completion, an average of 32 months | Peri-operative plasma will be taken from each patient for hematochemical analysis, in order to research of prognostic biomarkers. |
| Secondary | Proteomic analysis | At study completion, an average of 32 months | Peri-operative plasma will be taken from each patient for proteomic analysis, in order to research of prognostic biomarkers. |
| Secondary | Correlations between in vivo clinical response and effect of association measured in vitro on cell lines obtained from the same patient undergoing surgery | At the end of recruitment, an average of 18 months | In vitro cell response measured as cell growth inhibition and correlation with clinical response (PFS) of the same patient. |
| Secondary | Gene expression analysis | At the end of recruitment, an average of 18 months | Identifying the molecular phenotype of cells taken from patients' tissue samples during surgery and comparing clinical response and molecular phenotype by transcriptomic analysis |
Source ClinicalTrials.gov
Outcomes0
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/NCT05929495
GET https://conductscience.org/api/trials/v1/NCT05929495/registered