Trial · NCT07284069
Senicapoc and Perampanel for Newly Diagnosed Glioblastoma
NCT07284069, Early phase 1, Recruiting, Aarhus University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Senicapoc and Perampanel for Newly Diagnosed Glioblastoma. Trials, record NCT07284069. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07284069
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Senicapoc and Perampanel for Newly Diagnosed Glioblastoma
- NCT number
- NCT07284069
- Status
- Recruiting
- Phases
- Early phase 1
- Enrollment
- 36 participants, estimated
- Lead sponsor
- Aarhus University Hospital
- Conditions
- Glioblastoma
- Interventions
- senicapoc, Perampanel
- First posted
- 2025-12-16
- Last updated
- 2026-05-07
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerable dose of senicapoc monotherapy (mg) | First four weeks of treatment | The primary endpoint of the study's Part A will be the maximum tolerable dose of senicapoc monotherapy (milligrams, first four weeks) when added to standard-of-care therapy. |
| Primary | Number of patients in each group (2 and 3) excluded from the study due to intolerability when exposed to perampanel at the lowest dose (2 mg) | First six weeks of treatment | The primary endpoint of Part B is the number of patients in each group (2 and 3) excluded from the study due to intolerability when exposed to perampanel at the lowest dose (2 mg) within the first 6 weeks of treatment. |
| Secondary | Incidence and severity of adverse events | From inclusion until 30 days after treatment completion (approximately 150 days total). | Safety will be measured as the risk of adverse events and serious adverse events in each group, evaluated continuously from inclusion until \~30 days after patient exclusion, graded by Common Terminology Criteria for Adverse Events version 5.0 and tabulated by type, grade, and attribution. |
| Secondary | Overall survival | From randomization until death from any cause or End-of-trial (defined as 1 year after the last patient completes treatment in Part B), with an estimated maximum follow-up of approximately 24 months. | Overall survival is defined as the time from randomization to death from any cause. Patients still alive at End-of-trial or lost to follow-up will be censored at the date of last contact. End-of-trial is defined as 1 year after the last patient completes treatment in Part B, with an estimated maximum follow-up of approximately 24 months per participant. |
| Secondary | Progression-free survival | From randomization until first documented disease progression, death from any cause, or End-of-trial (defined as 1 year after the last patient completes treatment in Part B), with an estimated maximum follow-up of approximately 24 months. | Progression-free survival is defined as the time from randomization to first documented disease progression according to RANO 2.0 criteria or death from any cause, whichever occurs first. Patients without progression or death at End-of-trial or lost to follow-up will be censored at the date of last contact. End-of-trial is defined as 1 year after the last patient completes treatment in Part B, with an estimated maximum follow-up of approximately 24 months per participant. |
| Secondary | Objective response rate | From postoperative baseline MRI until documented disease progression or End-of-trial (defined as 1 year after the last patient completes treatment in Part B), with an estimated maximum follow-up of approximately 24 months. | Objective response rate is defined as the proportion of patients achieving complete or partial response according to RANO 2.0 criteria. Response is assessed relative to the postoperative baseline MRI obtained within 48 hours after surgery. Patients without a documented response at End-of-trial or lost to follow-up will be censored at the date of last contact. End-of-trial is defined as 1 year after the last patient completes treatment in Part B, with an estimated maximum follow-up of approximately 24 months per participant. |
| Secondary | Tumor volume | From postoperative baseline MRI (<48h) until radiological progression, death, or End-of-trial (1 year after last patient completes Part B), with an estimated maximum follow-up of ~24 months. | Tumor volume will be quantified based on manual or semiautomated segmentation of T2 FLAIR hyperintense and T1 contrast-enhancing lesions. Preoperative tumor volumes obtained approximately on day 10-14 will be compared to baseline postoperative MRI volumes obtained within 48 hours after surgery. Postoperative tumor volumes assessed on follow-up MRIs will be compared to this postoperative baseline. Aggregated volumes and volume changes compared to baseline will be reported for each time-point. |
| Secondary | Perampanel dose levels | First six weeks of treatment | In Part B, the mean maximum tolerated daily dose of perampanel achieved during the first six weeks of treatment will be recorded for each participant and compared between groups 2 (perampanel monotherapy) and 3 (perampanel + senicapoc). |
| Other | Peak plasma concentration (Cmax) of senicapoc | From Day 0 to ~30 days after last study-drug dose (blood samples at enrollment on Day 0, Days 12-14, Day 14, Days 14-16, Days 35-42, Days 90-100, Days 120-130, and up to 30 days post-treatment). | Cmax of senicapoc measured in serial blood samples using validated UHPLC-MS/MS methods. Samples are collected at predefined visits throughout the treatment period |
| Other | Peak plasma concentration (Cmax) of perampanel | From Day 0 to ~30 days after last study-drug dose (blood samples at enrollment on Day 0, Days 1-3, Days 12-14, Day 14, Days 14-16, Days 35-42, Days 90-100, Days 120-130, and up to 30 days post-treatment). | Cmax of perampanel measured in serial blood samples using validated HPLC-MS methods. Samples are collected at predefined visits throughout the treatment period. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36097070 | BACKGROUND |
Source PubMed
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/NCT07284069
GET https://conductscience.org/api/trials/v1/NCT07284069/registered?page=2