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NCT03970226 · ClinicalTrials.gov registry record · Early Phase 1
Tocilizumab in Children With ACP
A Early Phase 1 study of Adamantinomatous Craniopharyngioma, sponsored by University of Colorado, Denver.
- Active
- Registry status
- Early Phase 1
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT03970226: Active Early Phase 1 study of Adamantinomatous Craniopharyngioma, sponsored by University of Colorado, Denver.
NCT03970226 is a Early Phase 1 study of Adamantinomatous Craniopharyngioma that is active but no longer recruiting, run by University of Colorado, Denver. The registered enrollment target is 9 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03970226, a Early Phase 1 study of Adamantinomatous Craniopharyngioma, is active but no longer recruiting, sponsored by University of Colorado, Denver.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will be conducted in two phases. The first phase (phase 0) will be looking at patients with new or recurrent/ progressed craniopharyngioma tumors. These patients will be given one dose of tocilizumab before they have SOC surgery of their tumor. The objective of this phase is to see if drug reaches the tumor. If phase 0 is favorable and shows that drug is penetrating the tumor, the second phase of the study (feasibility phase) will open. Both phases will remain open concurrently and patients will be able to enroll on the Phase 0 then "roll over" and enroll on the feasibility phase. During the feasibility phase patients will be administered tocilizumab every two weeks for up to 13 cycles (approximately 1 year). Patients will be followed for up to 5 years in the feasibility phase.
Primary Outcome
Utilize biopsy and/or drainage to identify the presence of tocilizumab and its metabolites in adamantinomatous craniopharyngioma (ACP) tumor tissue and/or cyst fluid and/or CSF following one dose of systemically administered tocilizumab.
Conditions Studied
Interventions
- DRUG Tocilizumab
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2019-09-16 |
| Est. Completion | 2027-05 |
| Phase | Early Phase 1 |
What the registry record for NCT03970226 still lists
NCT03970226 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Adamantinomatous Craniopharyngioma appearing as the primary indexed condition, and to 1 intervention - of which Tocilizumab is the first listed.
NCT03970226 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT03970226 about?
NCT03970226 is a clinical study titled "Tocilizumab in Children With ACP". This study will be conducted in two phases. The first phase (phase 0) will be looking at patients with new or recurrent/ progressed craniopharyngioma tumors. These patients will be given one dose of tocilizumab before they have SOC surgery of their tumor. The objective of this phase is to see if dru...
What is the current status of trial NCT03970226?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 9 participants. The study started on 2019-09-16. Estimated completion is 2027-05.
What conditions does trial NCT03970226 study?
This clinical trial studies the following conditions: Adamantinomatous Craniopharyngioma.
What interventions are being tested in trial NCT03970226?
The interventions under investigation include: Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT03970226?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03970226 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Adamantinomatous Craniopharyngioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03970226's enrollment target sits among peer trials
9 1746th of 2000 higher than 219 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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