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NCT04299191 · ClinicalTrials.gov registry record · Phase 1
Study of LAM561 Acid in Pediatric Patients With Malignant Glioma and Other Advanced Solid Tumors
A Phase 1 study of High Grade Glioma and Solid Tumor, Unspecified, Child, sponsored by Laminar Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 3
- Study locations
NCT04299191: Recruiting Phase 1 study of High Grade Glioma and Solid Tumor, Unspecified, Child, sponsored by Laminar Pharmaceuticals.
NCT04299191 is a Phase 1 study of High Grade Glioma and Solid Tumor, Unspecified, Child that is actively recruiting participants, run by Laminar Pharmaceuticals. The registered enrollment target is 28 participants, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (57% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04299191, a Phase 1 study of High Grade Glioma and Solid Tumor, Unspecified, Child, is actively recruiting participants, sponsored by Laminar Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 3
- Study locations
Study Summary
An open label, non-randomized study in pediatric patients with advanced high-grade gliomas and other solid tumors. The study will be performed in two phases: a dose escalation phase in up to 18 patients following a standard "3+3" design to establish dose-limiting toxicity (DLT) and a "safe" dose of LAM561 followed by an expanded safety cohort of up to 10 patients treated at the Maximum Tolerated Dose (MTD). If the MTD is well tolerated in the expanded safety cohort, that dose becomes the Recommended Phase 2 Dose (RP2D). Glioma patients and other solid tumor patients (including non-glial brain tumors) will be treated as a single cohort. Patients with either tumor type will be allowed to enroll on the study as positions are made available. No tumor type will be given priority over another and there is no minimum number of glioma patients or solid tumor patients that must be enrolled on the trial.
Primary Outcome
To determine the safety and tolerability of LAM561 in pediatric patients (under 18 years) when administered orally using a continuous dosing schedule. It will be evaluated through the adverse events \[AEs\], physical examinations and vital signs, laboratory safety tests and 12-lead electrocardiograms \[ECGs\].
Conditions Studied
Interventions
- DRUG LAM561
Study Locations (3)
Arkansas
- Arkansas Children's Research Institute - Little Rock
Florida
- University of Miami Hospital - Miami
New Jersey
- Hackensack Meridian Health, Inc - Edison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT04299191 shows while recruiting
NCT04299191 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (57% lower).
The record links to 2 conditions, with High Grade Glioma appearing as the primary indexed condition, and to 1 intervention - of which LAM561 is the first listed.
NCT04299191 reports a single indexed study location in Arkansas, Florida, New Jersey.
Frequently Asked Questions
What is clinical trial NCT04299191 about?
NCT04299191 is a clinical study titled "Study of LAM561 Acid in Pediatric Patients With Malignant Glioma and Other Advanced Solid Tumors". An open label, non-randomized study in pediatric patients with advanced high-grade gliomas and other solid tumors. The study will be performed in two phases: a dose escalation phase in up to 18 patients following a standard "3+3" design to establish dose-limiting toxicity (DLT) and a "safe" dose of...
What is the current status of trial NCT04299191?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2020-09-01. Estimated completion is 2026-12.
What conditions does trial NCT04299191 study?
This clinical trial studies the following conditions: High Grade Glioma, Solid Tumor, Unspecified, Child.
What interventions are being tested in trial NCT04299191?
The interventions under investigation include: LAM561 (DRUG).
Who is sponsoring clinical trial NCT04299191?
This trial is sponsored by Laminar Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04299191 being conducted?
This trial has 3 study locations across Arkansas, Florida, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04299191's enrollment target sits among peer trials
28 26th of 42 higher than 16 of 42 other High Grade Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High Grade Glioma 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.
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