Trial · NCT03326388
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: To evaluate the Maximum Tolerated Dose | 6 months | Phase 1: Definition of the maximum tolerated dose using number of participants with treatment related adverse events as assessed by CTCAEv4.0 |
| Primary | Phase 2: Objective response rate in NF1 inoperable plexiform neurofibroma and optic pathway glioma | 2 years | Phase 2:To evaluate the objective response rate of children (≥3 and ≤ 18 years old) with NF1 and inoperable plexiform neurofibroma using 3D volumetric analysis. |
| Primary | Best Objective response rate in NF1 related optic pathway gliomas | 2 years | To evaluate the best objective response rate (including MR, PR and CR) of children (≥3 and ≤ 18 years old) with NF1 related optic pathway glioma using 2D assessment of tumour size. |
| Secondary | Cardiac Function - fractional shortening | 5 years | Number of patients with changes in changes from baseline in ejection fraction as assessed by echocardiogram. |
| Secondary | Cardiac Function - QTc | 5 years | Number of patients with changes from baseline in QTc as assessed by electrocardiogram. |
| Secondary | Retinal detachment. | 5 years | Number of participants with evidence of treatment related retinal detachment as per CTCAE v4. |
| Secondary | Treatment related Adverse Events | 5 years | Number of participants with Treatment- Related Adverse events as assessed by CTCAEv4.0. |
| Secondary | Pharmacokinetics of selumetinib. Phase 1 only | 6 months | Calulation of Area Under the Curve (AUC) tests to test exposure to the drug over time. AUC will be calculated at Day 1 and at steady state (Day 27/28) |
| Secondary | Pharmacokinetics of selumetinib. Phase 1 only | 6 months | Calculation of Time to reach peak concentration (Tmax) at day 1 and at steady state (Day 27/28) |
| Secondary | Pharmacokinetics of selumetinib. Phase 1 only | 6 months | Calculation of Peak concentration (Cmax) at day 1 and at steady state (Day 27/28) |
| Secondary | Pharmacokinetics of selumetinib. Phase 1 only | 6 months | Calculation of clearance of the drug from the blood after oral administration (CL/F) on day 1 and at steady state (D27/28) |
| Secondary | Time to progression - plexiform neurofibromas | 5 years | Definition of time to progression of plexiform neurofibromas as assessed by volumetric measurement. |
| Secondary | Time to progression - optic pathway gliomas | 5 years | Definition of time to progression as defined by changes from baseline using 2 dimensional assessment of tumour size |
| Secondary | Pain Evaluation - self reported changes | 3 years | Number of participants with a change from baseline as assessed by Numerical Scale Rating |
| Secondary | Pain Evaluation- Medication | 3 years | Number of participants with a change from baseline in pain medication as assessed by the pain medication survey. |
| Secondary | Evaluation of effect on disfigurement | 3 years | Photography evaluation (imaging including standardised imaging and 3D photography where available) to provide measurement (metric system eg cm) of change from baseline in size of deformity caused by plexiform neurofibroma. |
| Secondary | Quality of Life Evaluation | 3 years | Number of participants with a change from baseline in quality of life using the PedsQL assessment. |
| Secondary | Evaluation of Visual Function in NF1 related optic pathway glioma | 3 years | To determine the effect of selumetinib on visual function in subjects with NF1 related optic pathway glioma using the visual function assessments outlined by the Response Evaluation in Neurofibromatosis and Schwanomatosis (REiNS) criteria |
| Secondary | Physical functioning endurance | 3 years | Number of participants with a change in physical function as assessed using the 6 minute walk-run test. |
| Secondary | Evaluation of clinically stable NF1 related optic pathway glioma | 5 years. | To determine the effect of selumetinib on stable NF1 related optic pathway gliomas and other gliomas for subjects whose primary indication for treatment is a progressive plexiform neurofibroma using evaluation of CNS MRI imaging |
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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