NCT05825365 (PROTECT) is a Phase 2 clinical trial of Selumetinib in Neurofibromatosis Type 1, sponsored by AstraZeneca.

Who is sponsoring NCT05825365?

NCT05825365 is sponsored by AstraZeneca.

What drugs are being tested in NCT05825365?

Interventions in NCT05825365: Selumetinib, Placebo.

What condition does NCT05825365 study?

NCT05825365 studies Neurofibromatosis Type 1, Plexiform Neurofibromas, Post-operative.

Is NCT05825365 still recruiting?

NCT05825365 is currently withdrawn. Last updated 14 August 2023.

Last reviewed 2023-08-14 · How we verify

NCT05825365: PROTECT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Selumetinib in Chinese Paediatric With Post-operative NF1-PNs, PhaseⅡ, Double-Blinded, Placebo-Controlled Study

Withdrawn Phase 2 Last updated 14 August 2023

What this trial tests

Phase 2 trial testing Selumetinib in Neurofibromatosis Type 1. Withdrawn.

Timeline

31 August 2023

Primary endpoint
30 June 2026

30 June 2026

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Start date	31 August 2023
Primary completion	30 June 2026
Estimated completion	30 June 2026

Drugs / interventions tested

Selumetinib — full drug profile →
Placebo

Conditions studied

Neurofibromatosis Type 1 — all drugs for Neurofibromatosis Type 1 →
Plexiform Neurofibromas — all drugs for Plexiform Neurofibromas →
Post-operative — all drugs for Post-operative →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 3 to 18, any sex, with Neurofibromatosis Type 1 or Plexiform Neurofibromas. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a phase II, multicenter, randomised, parallel, double-blind, placebo-controlled study assessing the efficacy and safety of the MEKi selumetinib compared with placebo in Chinese paediatric participants with post-operative NF1-associated PNs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Selumetinib

Trials testing the same drug.

NCT06735820 — Early Phase Study Evaluating MEK and MDM2 Inhibition in Patients With NF1 and MPNST · Phase 1, PHASE2 · not yet recruiting
NCT06188741 — Selumetinib for the Prevention of Plexiform Neurofibroma Growth in NF Type 1 · Phase 2 · recruiting
NCT06763315 — Low-dose Selumetinib for the Treatment of Plexiform Neurofibromas in Chinese Children · Phase 2 · not yet recruiting
NCT06621082 — The Clinical Study of the Treatment of Patients With Type I Neurofibromatosis With Smetinib Hydrosulfate Capsule · Phase 2 · not yet recruiting
NCT06620354 — Clinical Study on the Treatment of Type I Neurofibromatosis With Smeitinib Hydrosulfate Capsule · Phase 2 · not yet recruiting

Other recruiting trials for Neurofibromatosis Type 1

Currently open trials in the same condition.

NCT06507748 — A Study to Evaluate the Feasibility of a Physiologic Biomarker to Assess Pain and Other Sensory Problems Using Pupillome · NA · recruiting
NCT07221331 — Prevalence, Clinical Characteristics, Progression, and Management of Neurofibromatosis Type 1 in Egypt (NF1-Egy) · recruiting
NCT06880991 — Development of Patient-Reported Outcome Measures Assessing Tumor Visibility and Appearance Concerns in Neurofibromatosis · recruiting
NCT05388370 — PASS of Paediatric Patients Initiating Selumetinib · active not recruiting
NCT05309668 — Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-re · Phase 1, PHASE2 · active not recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05825365 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 14 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05825365.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing