Can a low-fat meal ease stomach side effects of NF1 tumor drug?
NCT ID NCT05101148
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times
Summary
This study looks at whether taking selumetinib with a low-fat meal reduces stomach problems in teenagers with neurofibromatosis type 1 (NF1) who have tumors that cannot be removed by surgery. About 24 teens will take the drug under both fed and fasted conditions to compare drug levels and side effects. The goal is to find the best way to take selumetinib to keep it working while being easier on the stomach.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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24 people
The number who actually took part.
- Started
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Jul 2021
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male and female participants aged ≥ 12 to \< 18 years at the time of signing the informed consent. * All study participants must be diagnosed with (i) NF1 per NIH Consensus Development Conference Statement and (ii) inoperable PN. In addition to PN, participants must have at least 1 other diagnostic criterion for NF1 as defined in protocol. * Participants must require treatment for NF1 and inoperable PN due to actual symptoms or because of the potential to develop significant clinical complications, as judged by the Investigator, as defined in the protocol. * Participants who have had prior treatment with any MEKi (including selumetinib) may be considered for inclusion in this study. * Participants must have a BSA ≥ 1.3 and ≤ 2.5 m2 Exclusion Criteria: * Evidence or suspicion of optic glioma, malignant glioma, MPNST, or other cancer requiring treatment with chemotherapy or radiation therapy * Prior malignancy requiring active treatment (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the participant had been disease free for ≥ 2 years or which would not have limited survival to \< 2 years). * A life-threatening illness, medical condition, organ system dysfunction of laboratory finding which, in the Investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of selumetinib, or put the study outcomes at undue risk. * Participants with clinically significant cardiovascular disease as listed in the protocol. * Liver function tests: bilirubin \> 1.5 × the ULN for age (with the exception of those with Gilbert syndrome) or AST/ALT \> 2 × upper limit of normal. * Renal Function: Creatinine clearance or radioisotope glomerular filtration rate \< 30 mL/min/1.73 m2 or a serum creatinine \> 1.2 mg/dL (for participants aged between 12 and 15 years) or \> 1.5 mg/dL for participants aged \> 15 years). * Participants with abnormal ophthalmological findings/conditions as listed in the protocol. * Have any unresolved chronic toxicity, associated with previous therapy for NF1-PN: Gastrointestinal toxicity of CTCAE Grade 1 or higher; Have any other unresolved chronic toxicity with CTCAE Grade ≥ 2, except hair changes (such as alopecia or hair lightening). * Participants who have previously been treated with a MEKi (including selumetinib) and either discontinued treatment or required a dose reduction due to toxicity * Have had recent major surgery within a minimum of 4 weeks prior to starting study intervention, with the exception of surgical placement for vascular access. Have planned major surgery during the treatment period. * Any multivitamin containing vitamin E must be stopped at least 7 days prior to initiation of selumetinib.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Rochester, Minnesota, 55905, United States
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Research Site
Akron, Ohio, 44308, United States
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Research Site
Bydgoszcz, 85-094, Poland
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Research Site
Gdansk, 80-952, Poland
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Research Site
Warsaw, 02-091, Poland
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Research Site
Moscow, 119620, Russia
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Research Site
Moscow, 125412, Russia
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Research Site
Barcelona, 08950, Spain
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Research Site
Madrid, 28009, Spain
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a cholesterol drug boost reading skills in kids with NF1?
- Antioxidant drug shows promise for kids with NF1
- Can a simple walk test spot motor trouble in kids with NF1?
- Could a cancer drug shrink Children's brain tumors?
- New drug aims to help kids with rare genetic short stature grow taller