Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05309668 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN
A Phase 1 study of Neurofibromatosis Type 1, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 16
- Study locations
NCT05309668: Active Phase 1 study of Neurofibromatosis Type 1, sponsored by AstraZeneca.
NCT05309668 is a Phase 1 study of Neurofibromatosis Type 1 that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 36 participants, below the 158-participant average among 17 other Neurofibromatosis Type 1 trials with a reported enrollment target (77% lower). The trial reports 16 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05309668, a Phase 1 study of Neurofibromatosis Type 1, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 16
- Study locations
Study Summary
This study is designed to define a dosing regimen and assess the pharmacokinetics(PK) and safety of the granule formulation; the study will also include descriptive analyses of exploratory efficacy endpoints. The study will inform the benefit risk profile of the granule formulation in children aged ≥ 1 to \< 7 years with NF1 related symptomatic, inoperable PN.
Primary Outcome
To determine the pharmacokinetics of selumetinib after administration of the selumetinib granule formulation
Conditions Studied
Interventions
- DRUG Selumetinib granule formulation
- DRUG Selumetinib capsule formulation
Study Locations (16)
Other
- Research Site - Hamburg
- Research Site - München
- Research Site - Tübingen
- Research Site - Milan
- Research Site - Rome
- Research Site - Nagoya
- Research Site - Setagaya City
- Research Site - Rotterdam
- Research Site - Moscow
- Research Site - Moscow
- Research Site - Barcelona
- Research Site - Madrid
Ohio
- Research Site - Akron
Pennsylvania
- Research Site - Philadelphia
Texas
- Research Site - Houston
Virginia
- Research Site - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-01-21 |
| Est. Completion | 2028-04-28 |
| Phase | Phase 1 |
What the registry record for NCT05309668 still lists
NCT05309668 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 158-participant average among 17 other Neurofibromatosis Type 1 trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Neurofibromatosis Type 1 appearing as the primary indexed condition, and to 2 interventions - of which Selumetinib granule formulation is the first listed.
NCT05309668 lists 16 locations in 5 states (Other, Ohio, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT05309668 about?
NCT05309668 is a clinical study titled "Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged ≥1 to <7 Years With NF1-related Symptomatic, Inoperable PN". This study is designed to define a dosing regimen and assess the pharmacokinetics(PK) and safety of the granule formulation; the study will also include descriptive analyses of exploratory efficacy endpoints. The study will inform the benefit risk profile of the granule formulation in children aged ...
What is the current status of trial NCT05309668?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2022-01-21. Estimated completion is 2028-04-28.
What conditions does trial NCT05309668 study?
This clinical trial studies the following conditions: Neurofibromatosis Type 1.
What interventions are being tested in trial NCT05309668?
The interventions under investigation include: Selumetinib granule formulation (DRUG), Selumetinib capsule formulation (DRUG).
Who is sponsoring clinical trial NCT05309668?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05309668 being conducted?
This trial has 16 study locations across Ohio, Pennsylvania, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neurofibromatosis Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05309668's enrollment target sits among peer trials
36 13th of 17 higher than 5 of 17 other Neurofibromatosis Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurofibromatosis Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors
ACTIVE NOT RECRUITING · Phase 1
-
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
ACTIVE NOT RECRUITING · Phase 1
-
Vaccine Therapy in Treating Patients with Malignant Peripheral Nerve Sheath Tumor That is Recurrent or Cannot Be Removed by Surgery
COMPLETED · Phase 1
-
Identification of Pre-Malignant Lesions In Pediatric Patients With Neurofibromatosis Type 1 Using Novel Magnetic Resonance Imaging Techniques Paired With Artificial Intelligence
RECRUITING · NA
-
Development of Patient-Reported Outcome Measures Assessing Tumor Visibility and Appearance Concerns in Neurofibromatosis Type 1: A Qualitative Study
RECRUITING
-
A Study to Evaluate the Feasibility of a Physiologic Biomarker to Assess Pain and Other Sensory Problems Using Pupillometry in Participants With Neurofibromatosis Type 1 (NF1)
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00929006 · 36 participants · Early Phase 1
Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
- NCT01891318 · 36 participants · Phase 1
Neoadjuvant Radiosurgery for Resectable Brain Metastases: Phase I/II Study
- NCT02291848 · 36 participants · Phase 1
Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma
- NCT02366819 · 36 participants · Phase 4
Genetic Analysis-Guided Irinotecan Hydrochloride Dosing of mFOLFIRINOX in Treating Patients With Locally Advanced Gastroesophageal or Stomach Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI