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NCT05465174 · ClinicalTrials.gov registry record · Phase 2
Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults
A Phase 2 study of Craniopharyngioma and Craniopharyngioma, Child, sponsored by Sabine Mueller, MD, PhD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
- 19
- Study locations
NCT05465174: Recruiting Phase 2 study of Craniopharyngioma and Craniopharyngioma, Child, sponsored by Sabine Mueller, MD, PhD.
NCT05465174 is a Phase 2 study of Craniopharyngioma and Craniopharyngioma, Child that is actively recruiting participants, run by Sabine Mueller, MD, PhD. The registered enrollment target is 57 participants, below the 207-participant average among 6 other Craniopharyngioma trials with a reported enrollment target (72% lower). The trial reports 19 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05465174, a Phase 2 study of Craniopharyngioma and Craniopharyngioma, Child, is actively recruiting participants, sponsored by Sabine Mueller, MD, PhD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
- 19
- Study locations
Study Summary
The current study assesses the tolerability and efficacy of monotherapy with pan-RAF-kinase (Tovorafenib) inhibition for the treatment of children and young adults with craniopharyngioma.
Primary Outcome
Progression-free survival is defined as the time of documented response until disease progression as defined by Response assessment in neuro-oncology criteria (RANO) criteria. PFS will be reported by overall group at 12 months.
Conditions Studied
Interventions
- DRUG Tovorafenib
Study Locations (19)
California
- Rady Children's Hospital/University of California, San Diego - San Diego
- University of California, San Francisco - San Francisco
Alabama
- University of Alabama at Birmingham - Birmingham
Florida
- University of Florida - Gainesville
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Indiana
- Riley Hospital for Children at Indiana University Health - Indianapolis
Maryland
- John Hopkins University - Baltimore
Massachusetts
- Dana-Farber/Boston Children's Harvard Medical School - Boston
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2022-09-12 |
| Est. Completion | 2028-03-01 |
| Phase | Phase 2 |
What NCT05465174 shows while recruiting
NCT05465174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 207-participant average among 6 other Craniopharyngioma trials with a reported enrollment target (72% lower).
The record links to 3 conditions, with Craniopharyngioma appearing as the primary indexed condition, and to 1 intervention - of which Tovorafenib is the first listed.
NCT05465174 lists 19 locations in 18 states (California, Alabama, Florida).
Frequently Asked Questions
What is clinical trial NCT05465174 about?
NCT05465174 is a clinical study titled "Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults". The current study assesses the tolerability and efficacy of monotherapy with pan-RAF-kinase (Tovorafenib) inhibition for the treatment of children and young adults with craniopharyngioma.
What is the current status of trial NCT05465174?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2022-09-12. Estimated completion is 2028-03-01.
What conditions does trial NCT05465174 study?
This clinical trial studies the following conditions: Craniopharyngioma, Craniopharyngioma, Child, Recurrent Craniopharyngioma.
What interventions are being tested in trial NCT05465174?
The interventions under investigation include: Tovorafenib (DRUG).
Who is sponsoring clinical trial NCT05465174?
This trial is sponsored by Sabine Mueller, MD, PhD, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05465174 being conducted?
This trial has 19 study locations across Alabama, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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