Trial · NCT06095375
Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients
NCT06095375, Phase 1, Completed, Istituto Oncologico Veneto IRCCS
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients. Trials, record NCT06095375. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06095375
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients
- NCT number
- NCT06095375
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 21 participants, actual
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Conditions
- Glioblastoma, IDH-wildtype, MGMT-Methylated Glioblastoma
- Interventions
- Regorafenib, Temozolomide
- First posted
- 2023-10-23
- Last updated
- 2026-11-04
- Other registries' IDs
- eudract:2021-001604-15
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of patients with a Dose Limiting Toxicity (DLT) | During dose escalation, the DLT evaluation period will be two cycles from Day -1 of Cycle 1 of adjuvant phase (cohort A) or from Day 1 to last day of the concomitant RT phase (Cohort B). (each cycle is 28 days) | |
| Primary | Number of patients with ≥1 adverse event (AE) using the NCI CTCAE v5.0 | evaluation period will be two cycles from Day -1 of Cycle 1 of adjuvant phase (cohort A) or from Day 1 to last day of the concomitant RT phase (Cohort B). (each cycle is 28 days) | * Grade 3 diarrhea, nausea, vomiting, and loss of appetite if lasting for ≥ 7 consecutive days; * Grade 3 electrolyte imbalance if lasting for ≥ 7 consecutive days; * Grade 3 dermal toxicity if lasting for ≥ 7 consecutive days; * Grade 3 fatigue for ≥ 7 consecutive days; * Grade 4 T-Bil, AST (GOT) and/or ALT (GPT) elevations, |
| Primary | Number of patients discontinuing study treatment due to an AE | evaluation period will be two cycles from Day -1 of Cycle 1 of adjuvant phase (cohort A) or from Day 1 to last day of the concomitant RT phase (Cohort B). (each cycle is 28 days) | Number of patients discontinuing study treatment due to an AE |
| Secondary | Pharmacokinetics parameters - AUC | evaluation period will be two cycles from Day -1 of Cycle 1 of adjuvant phase (cohort A) or from Day 1 to last day of the concomitant RT phase (Cohort B). (each cycle is 28 days) | area under the plasma concentration versus time curve |
| Secondary | Best response to treatment according to RANO criteria | from date of randomization until the date of first occurrence of disease progression or death, whichever come first,assessed up to 32 months | Tumor response according to RANO criteria |
| Secondary | Progression-free survival | from the start of radiotherapy until the date of first occurrence of disease progression or death whichever come first,assessed up to 32 months | Survival time without tumor progression |
| Secondary | EORTC QLQ-C30 | from the start of radiotherapy until the date of first occurrence of disease progression or death whichever come first,assessed up to 32 months | Survey with evaluations at screening, concurrently to brain MRI assessment and at the end of treatment |
| Secondary | Pharmacokinetics parameters - Tmax | evaluation period will be two cycles from Day -1 of Cycle 1 of adjuvant phase (cohort A) or from Day 1 to last day of the concomitant RT phase (Cohort B). (each cycle is 28 days) | Time to peak drug concentration |
| Secondary | Pharmacokinetics parameters - Cmax | evaluation period will be two cycles from Day -1 of Cycle 1 of adjuvant phase (cohort A) or from Day 1 to last day of the concomitant RT phase (Cohort B). (each cycle is 28 days) | Peak plasma concentration |
| Secondary | Overall survival | from the start of radiotherapy until death ,assessed up to 32 months |
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/NCT06095375
GET https://conductscience.org/api/trials/v1/NCT06095375/registered