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NCT05286788 · ClinicalTrials.gov registry record · Phase 2
MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma
A Phase 2 study of Recurrent Adamantinomatous Craniopharyngioma and Adamantinous Craniopharyngioma, sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 10
- Study locations
NCT05286788: Recruiting Phase 2 study of Recurrent Adamantinomatous Craniopharyngioma and Adamantinous Craniopharyngioma, sponsored by Nationwide Children's Hospital.
NCT05286788 is a Phase 2 study of Recurrent Adamantinomatous Craniopharyngioma and Adamantinous Craniopharyngioma that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05286788, a Phase 2 study of Recurrent Adamantinomatous Craniopharyngioma and Adamantinous Craniopharyngioma, is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 10
- Study locations
Study Summary
MEKTOVI (binimetinib) is an oral, highly selective reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2. The biological activity of binimetinib that has been evaluated bith in vitro and in vivo in a wide variety of tumor types In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy.
Primary Outcome
To calculate the number of patients who experience sustained objective response rate \[minor response (MR) + partial response (PR) + complete response (CR)\] of patients with recurrent/progressive previously irradiated Adamantinomatous Craniopharyngioma to treatment with oral binimetinib (Stratum 1).
Conditions Studied
Interventions
- DRUG Binimetinib Oral Tablet [Mektovi]
Study Locations (10)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- Nicklaus Children's Hospital - Miami
New South Wales
- Sydney Children's Hospital - Randwick
Queensland
- Queensland Children's Hospital - South Brisbane
Western Australia
- Perth Children's Hospital - Perth
British Columbia
- British Columbia Children's Hospital - Vancouver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2023-04-10 |
| Est. Completion | 2027-04-10 |
| Phase | Phase 2 |
What NCT05286788 shows while recruiting
NCT05286788 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Recurrent Adamantinomatous Craniopharyngioma appearing as the primary indexed condition, and to 1 intervention - of which Binimetinib Oral Tablet [Mektovi] is the first listed.
NCT05286788 lists 10 locations in 9 states (Ohio, Colorado, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT05286788 about?
NCT05286788 is a clinical study titled "MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma". MEKTOVI (binimetinib) is an oral, highly selective reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2. The biological activity of binimetinib that has been evaluated bith in vitro and in vivo in a wide variety of tumor types In this Phase II, the drug w...
What is the current status of trial NCT05286788?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2023-04-10. Estimated completion is 2027-04-10.
What conditions does trial NCT05286788 study?
This clinical trial studies the following conditions: Recurrent Adamantinomatous Craniopharyngioma, Adamantinous Craniopharyngioma.
What interventions are being tested in trial NCT05286788?
The interventions under investigation include: Binimetinib Oral Tablet [Mektovi] (DRUG).
Who is sponsoring clinical trial NCT05286788?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05286788 being conducted?
This trial has 10 study locations across Colorado, District of Columbia, Florida, Ohio, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05286788's enrollment target sits among peer trials
38 1467th of 2000 higher than 518 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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