Trial · NCT04775485
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Arm 1: Overall response rate | Up to 48 months | ORR is defined as percentage of participants with best overall confirmed response of complete response (CR) or partial response (PR) by the Response Assessment in Neuro-Oncology - high-grade glioma (RANO-HGG) criteria. |
| Primary | Arm 2: Number of participants reporting adverse events | Up to 48 months | An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Primary | Arm 2: Number of participants with clinically significant changes in clinical chemistry parameters | Up to 48 months | |
| Primary | Arm 2: Number of participants with clinically significant changes in hematology parameters | Up to 48 months | |
| Primary | Arm 3: Overall response rate | Up to 48 months | Determined by the treating investigator and measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or RANO-HGG criteria, as appropriate. |
| Secondary | Arm 1 and 3: Number of participants reporting adverse events | Up to 48 months | An adverse event (AE) is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Secondary | Arm 1 and 3: Number of participants with clinically significant changes in clinical chemistry parameters | Up to 48 months | |
| Secondary | Arm 1 and 3: Number of participants with clinically significant changes in hematology parameters | Up to 48 months | |
| Secondary | Arm 1: Area under the concentration-time curve (AUC) of Tovorafenib | Cycle 1: Day 1 and Day 15; Cycles 2, 4, 7, 10 and 13: Day 1 | |
| Secondary | Arm 1: Minimum drug concentration (Cmin) | Cycle 1: Day 1 and Day 15; Cycles 2, 4, 7, 10 and 13: Day 1 | |
| Secondary | Arm 1: Change from Baseline QT interval corrected for heart rate by Fridericia's formula (ΔQTcF) | Baseline to 48 months | |
| Secondary | Arm 1: Change from Baseline PR interval (ΔPR) | Baseline to 48 months | |
| Secondary | Arm 1: Change from Baseline QRS interval (ΔQRS) | Baseline to 48 months | |
| Secondary | Arm 1: Change from baseline heart rate (ΔHR) | Baseline to 48 months | |
| Secondary | Arm 1: Change in electrocardiogram (ECG) waveform morphology | Baseline to 48 months | |
| Secondary | Arm 1 and Arm 2: Overall response rate | Up to 48 months | ORR is defined as percentage of participants with best overall confirmed response of CR or PR by the RANO-HGG criteria. |
| Secondary | Arm 1, Arm 2 and Arm 3: Overall response rate in Pediatric participants | Up to 48 months | ORR is defined as percentage of participants with best overall confirmed response of CR or PR or minor response (MR) by Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria.CR or PR by RECIST v1.1 criteria. |
| Secondary | Arm 1, Arm 2 and Arm 3: duration of progression-free survival (PFS) | Up to 48 months | PFS as defined by the time following initiation of tovorafenib to progression or death in participants treated with tovorafenib measured by RECIST v1.1, RAPNO, or RANO-HGG criteria as determined by the treating investigator and an IRC. |
| Secondary | Arm 1, Arm 2 and Arm 3: Duration of response (DOR) | Up to 48 months | DOR as defined by the length of response in participants with best overall confirmed response of CR or PR or MR and measured by RANO-HGG, RAPNO, and/or RECIST v1.1 criteria, as applicable. |
| Secondary | Arm 1, Arm 2 and Arm 3: Time to response (TTR) | Up to 48 months | TTR as defined as the time to first response following initiation of tovorafenib in participants with best overall confirmed response of CR or PR measured by RECIST v1.1 or RANO-HGG criteria, as applicable. |
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
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GET https://conductscience.org/api/trials/v1/NCT04775485/registered