Trial · NCT06095375
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 | 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 | |
| Secondary | Brain module BN20 | 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 |
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/NCT06095375/registered