Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Tolerability of Selumetinib in Adolescent Children With Neurofibromatosis Type 1 Related Plexiform Neurofibromas
← catalyst calendarSponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Merck Sharp & Dohme LLC.
Phase
Phase 1
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
24actual
Sites
9
Countries
Poland, Russia, Spain +1
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-07-21 | actual | When the study began enrolling |
| Primary completion | 2022-04-06 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-04-28 | estimated | The whole study's end, after follow-up |
| First posted | 2021-11-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Neurofibromatosis Type 1
Intervention
- Drug: Selumetinib
Primary outcomes
what the primary-completion date above is the date OFSelumetinib area under the plasma concentration-time curve from zero to 12 hours post-dose (AUC0-12)
measured At pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose (Cycle 1 Day 8 of each treatment period 1, 2 and 3); Each treatment period 1 and 2 has 1 cycle (Each cycle is 28 days). If needed, treatment period 3 will be started approximately 5 cycles later.
Gastrointestinal Adverse Events graded by CTCAE Ver 5.0 (Grade 1 to 5)
measured from screening until 30 days after last dose
Assessing change of Gastrointestinal toxicity diary: Modified Bristol Stool Form Scale for Children (mBSFS-C)
measured At screening (at least 14 days), Cycle 1 of each treatment period 1, 2 and 3 (1 cycle is 28 days)
Assessing change of Gastrointestinal toxicity diary: Nausea and Vomiting Symptom Rating Scale (adapted from the Children's Cancer and Leukaemia Group)
measured At screening (at least 14 days), Cycle 1 of each treatment period 1, 2 and 3 (1 cycle is 28 days)
Number of patients who take each gastrointestinal medication
measured From screening until 30 days after last dose
Proportion of patients who take each gastrointestinal medication
measured From screening until 30 days after last dose
Publications
- PMID 38721358 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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