Trial · NCT07284069
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| 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. |
| Other | Area under the plasma concentration-time curve (AUC) of senicapoc | 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). | AUC of senicapoc measured in serial blood samples using validated UHPLC-MS/MS methods. Samples are collected at predefined visits throughout the treatment period. |
| Other | Area under the concentration-time curve (AUC) 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). | AUC of perampanel measured in serial blood samples using validated HPLC-MS methods. AUC will be estimated using non-compartmental analysis based on predefined serial blood sampling throughout the treatment period. |
| Other | Elimination half-life (t½) of senicapoc | 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 | Elimination half-life (t½) of senicapoc estimated from serial blood concentrations using validated UHPLC-MS/MS methods and non-compartmental pharmacokinetic analysis. |
| Other | Elimination half-life (t½) 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). | Elimination half-life (t½) of perampanel estimated from serial blood concentrations using validated HPLC-MS methods and non-compartmental pharmacokinetic analysis. |
| Other | Senicapoc and perampanel concentrations in cerebrospinal fluid (CSF) | CSF at surgery and at postoperative Days 14-16, 35-42, 90-100, 120-130, and up to ~30 days post-treatment. | CSF concentrations of senicapoc and perampanel measured using validated analytical methods. CSF samples are collected at predefined postoperative time points and compared with plasma levels. |
| Other | Senicapoc and perampanel concentrations in tumor and peritumoral brain tissue | At time of surgery (approximately Day 14) | Concentrations of senicapoc and perampanel in tumor tissue and peritumoral brain tissue obtained during surgery and quantified using validated analytical methods. Tissue concentrations will be compared with matched plasma and cerebrospinal fluid levels. |
| Other | Molecular biomarker status: MGMT-promotor methylation status | At the time of surgery (from resected tumor tissue) | MGMT-promotor methylation status evaluated from resected tumor tissue. |
| Other | Molecular biomarker status: CHI3L1-conductivity score | At the time of surgery (resected tumor tissue) | CHI3L1-conductivity score evaluated from resected tumor tissue. |
| Other | Molecular biomarker status: Neural epigenetic signature | At the time of surgery (resected tumor tissue) | Neural epigenetic signatures evaluated from resected tumor tissue. |
| Other | Proportion of cellular subtypes in tumor and peritumoral tissue | At time of surgery (resected tumor tissue). | Proportions of glioblastoma cellular subtypes (NPC-like, OPC-like, MES-like, AC-like) will be quantified using single-cell RNA sequencing of tumor core and peritumoral tissue obtained at surgery. Subtype proportions will be compared between treatment groups. |
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.
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