Trial · NCT03326388
Intermittent Dosing Of Selumetinib In Childhood NF1 Associated Tumours
NCT03326388, Phase 1, Phase 2, Completed, Great Ormond Street Hospital for Children NHS Foundation Trust
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intermittent Dosing Of Selumetinib In Childhood NF1 Associated Tumours. Trials, record NCT03326388. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03326388
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intermittent Dosing Of Selumetinib In Childhood NF1 Associated Tumours
- NCT number
- NCT03326388
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Conditions
- Neurofibromatosis Type 1, Plexiform Neurofibroma, Optic Nerve Glioma
- Interventions
- Selumetinib
- First posted
- 2017-10-31
- Last updated
- 2024-04-04
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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) |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT03326388
GET https://conductscience.org/api/trials/v1/NCT03326388/registered?page=2