Trial · NCT07888517
Observational Study of the Real-world Effectiveness and Safety of Selumetinib Treating Adult Patients With Neurofibromatosis Type 1 (NF1) Who Have Symptomatic, Inoperable Plexiform Neurofibroma (PN)
NCT07888517, Recruiting, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Observational Study of the Real-world Effectiveness and Safety of Selumetinib Treating Adult Patients With Neurofibromatosis Type 1 (NF1) Who Have Symptomatic, Inoperable Plexiform Neurofibroma (PN). Trials, record NCT07888517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07888517
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observational Study of the Real-world Effectiveness and Safety of Selumetinib Treating Adult Patients With Neurofibromatosis Type 1 (NF1) Who Have Symptomatic, Inoperable Plexiform Neurofibroma (PN)
- NCT number
- NCT07888517
- Status
- Recruiting
- Enrollment
- 800 participants, estimated
- Lead sponsor
- AstraZeneca
- Conditions
- Neurofibromatosis Type 1 (NF1)
- First posted
- 2026-10-22
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ORR of PN by REiNS criteria. | 96 weeks | To describe the objective response rate (ORR) of PN as assessed by the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) criteria |
| Primary | QoL change from baseline by INF1-QoL(IMPACT OF NEUROFIBROMATOSIS 1 ON QUALITY-OF-LIFE) questionnaire. | 96 weeks | To assess the change from baseline in quality of life (QoL) using the impact of neurofibromatosis 1 on quality-of-life questionnaire (INF1-QoL) questionnaire. The QoL score ranges from 0 to 42. Higher scores indicate worse quality of life. Therefore, a greater decrease from baseline in the QoL score represents an improvement in quality of life and a better outcome. |
| Secondary | The median best tumour volume change of PN from baseline | 96 weeks | To assess the median best percentage change in PN tumour volume. |
| Secondary | The change of the diameter of cNF from baseline. | 96 weeks | To assess the change in the diameter of cutaneous neurofibromas (cNF). |
| Secondary | AE/ADRs/SAE. | 96 weeks | To characterize the safety profile of selumetinib by assessing AEs, adverse drug reactions (ADRs), and serious adverse events (SAEs). |
| Secondary | Percentage of patients with prior PN surgeries | 96 weeks | Percentage of Chinese adult NF1-PN patients who underwent PN surgery prior to initiation of selumetinib treatment. Unit of Measure: Participants (%) |
| Secondary | Number of prior PN surgeries | 96 weeks | Number of PN surgeries undergone by patients before initiation of selumetinib treatment. Unit of Measure: Number |
| Secondary | Percentage of patients undergoing PN surgery during selumetinib treatment | 96 weeks | Percentage of Chinese adult NF1-PN patients who underwent PN surgery while receiving selumetinib treatment. Unit of Measure: Participants (%) |
| Secondary | Interval between PN surgery and initiation of selumetinib treatment | 96 weeks | Time interval between PN surgery and initiation of selumetinib treatment. Unit of Measure: Days. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07888517
GET https://conductscience.org/api/trials/v1/NCT07888517/registered