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NCT06693284 · ClinicalTrials.gov registry record · Early Phase 1
A Window of Opportunity Trial of Mirdametinib Plus Vorinostat for NF1 Associated, H3K27 Trimethylation Deficient Malignant Peripheral Nerve Sheath Tumor [MPNST]
A Early Phase 1 study of Primary Malignant Peripheral Nerve Sheath Tumors, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT06693284 is a Early Phase 1 study of Primary Malignant Peripheral Nerve Sheath Tumors that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 8 participants. The trial reports 1 study location across 1 state.
The verdict
NCT06693284, a Early Phase 1 study of Primary Malignant Peripheral Nerve Sheath Tumors, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single center Phase 0 "window of opportunity" trial for the treatment of newly diagnosed, PRC2 deficient, primary malignant peripheral nerve sheath tumors (MPNSTs) with a short course of the combination of mirdametinib and vorinostat prior to the most appropriate standard of care treatment for their specific tumor (typically localized radiation followed by surgical resection). Four to eight patients, 12 years of age or older and meeting the study's biomarker inclusion criteria, would be enrolled onto this trial. After voluntary written consent (assent with parent consent for minors) the patient undergoes MRI and PET imaging of the tumor and a needle biopsy to collect tumor is performed. Patients with histone H3K27 trimethylation deficient MPNST, as confirmed by immunohistochemistry, receive a single 28-day course of mirdametinib and vorinostat at standard oral dosing for each. At day 26, 27, or 28 the patient returns to clinic for a research visit repeating the baseline MRI and PET imaging and the needle biopsy for tumor tissue. This ends direct study participation. The patient goes on to the most appropriate standard of care treatment for their MPNST. Information about the subsequent standard of care treatment is collected for the purposes of this study.
Conditions Studied
Interventions
- DRUG mirdametinib and vorinostat
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2025-11-20 |
| Est. Completion | 2027-01-01 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06693284
The ClinicalTrials.gov registry entry for NCT06693284 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Malignant Peripheral Nerve Sheath Tumors appearing as the primary indexed condition, and to 1 intervention - of which mirdametinib and vorinostat is the first listed.
NCT06693284 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT06693284 about?
NCT06693284 is a clinical study titled "A Window of Opportunity Trial of Mirdametinib Plus Vorinostat for NF1 Associated, H3K27 Trimethylation Deficient Malignant Peripheral Nerve Sheath Tumor [MPNST]". This is a single center Phase 0 "window of opportunity" trial for the treatment of newly diagnosed, PRC2 deficient, primary malignant peripheral nerve sheath tumors (MPNSTs) with a short course of the combination of mirdametinib and vorinostat prior to the most appropriate standard of care treatment...
What is the current status of trial NCT06693284?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 8 participants. The study started on 2025-11-20. Estimated completion is 2027-01-01.
What conditions does trial NCT06693284 study?
This clinical trial studies the following conditions: Primary Malignant Peripheral Nerve Sheath Tumors.
What interventions are being tested in trial NCT06693284?
The interventions under investigation include: mirdametinib and vorinostat (DRUG).
Who is sponsoring clinical trial NCT06693284?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06693284 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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