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Can a low-fat meal ease stomach side effects of NF1 tumor drug?

NCT ID NCT05101148

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

24 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

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

12 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • Research Site

    Rochester, Minnesota, 55905, United States

  • Research Site

    Akron, Ohio, 44308, United States

  • Research Site

    Bydgoszcz, 85-094, Poland

  • Research Site

    Gdansk, 80-952, Poland

  • Research Site

    Warsaw, 02-091, Poland

  • Research Site

    Moscow, 119620, Russia

  • Research Site

    Moscow, 125412, Russia

  • Research Site

    Barcelona, 08950, Spain

  • Research Site

    Madrid, 28009, Spain

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