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NCT06621082
The Clinical Study of the Treatment of Patients With Type I Neurofibromatosis With Smetinib Hydrosulfate Capsule
Phase 2 trial testing Selumetinib in Neurofibromatosis 1 in 19 participants. Not yet recruiting.
30 November 2026
Quick facts
| Lead sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 19 |
| Start date | 30 September 2024 |
| Primary completion | 30 November 2026 |
| Estimated completion | 31 December 2026 |
Drugs / interventions tested
- Selumetinib — full drug profile →
Conditions studied
- Neurofibromatosis 1 — all drugs for Neurofibromatosis 1 →
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Who can join
18 and older, any sex, with Neurofibromatosis 1. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study focused on patients with type I neurofibromatosis undergoing surgical treatment, who currently lack effective drug therapy and have a high recurrence rate after surgical resection. For patients with small solid tumors, limited space, and no invasion of the brain, spine and other important organs, surgical treatment is the main treatment. As a MEK inhibitor, Smetinib bisulfate capsule can induce tumor shrinkage and reduce postoperative recurrence by selectively binding mitogen-activated protein kinase (MEK) 1/2 protein to block the mitogen-activated protein kinase/extracellular signal regulatory kinase signaling pathway that regulates key cell responses. The purpose of this study was to treat patients with type I neurofibromatosis with indications of surgery with the drug smetinib bisulfate after surgical treatment, observe the therapeutic effect of the drug in stages, consolidate the postoperative effect and reduce the recurrence rate. In this study, progression-free survival (PFS) after postoperative drug treatment was used as the main outcome index, and duration of remission (DOR) and objective response rate (ORR) were used as secondary outcome indicators to investigate the efficacy of the use of Smetinib hydrosulfate capsule on tumor control, reduction of recurrence rate and stability of efficacy in patients with type I neurofibromatosis after surgery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06621082
- Europe PMC full search
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Related trials
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
- NCT06620354 — Clinical Study on the Treatment of Type I Neurofibromatosis With Smeitinib Hydrosulfate Capsule · Phase 2 · not yet recruiting
- NCT05825365 — Selumetinib in Chinese Paediatric With Post-operative NF1-PNs, PhaseⅡ, Double-Blinded, Placebo-Controlled Study · Phase 2 · withdrawn
Other recruiting trials for Neurofibromatosis 1
Currently open trials in the same condition.
- NCT07233408 — Tailoring an Online Platform to Promote Evidence-Based Care for Adults With Neurofibromatosis 1 and Low Health Literacy · NA · recruiting
- NCT06188741 — Selumetinib for the Prevention of Plexiform Neurofibroma Growth in NF Type 1 · Phase 2 · recruiting
- NCT06222203 — Surveillance for Malignant Transformation of Neurofibromatosis Type 1 (NF1) Related Peripheral Nerve Sheath Tumors (PNST · recruiting
- NCT06360406 — Real-World Treatment Study of Koselugo (Selumetinib) · recruiting
- NCT05361811 — Acceptance and Commitment Therapy for Caregivers of Children With a RASopathy: An Internal Pilot Feasibility Study and F · NA · recruiting
Other Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06621082 (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 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Last refreshed: 1 October 2024
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/NCT06621082.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing