Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Conditions Studied

High Grade Glioma Solid Tumor, Unspecified, Child

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

FieldValue
Enrollment Target 28 participants
Start Date 2020-09-01
Est. Completion 2026-12
Phase Phase 1

Sponsor

Laminar Pharmaceuticals

1 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04299191

The ClinicalTrials.gov registry entry for NCT04299191 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (57% lower). The listed sponsor is Laminar Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 3 distinct geographic areas - top geographies include 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

Similar trials for High Grade Glioma

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.

Explore more on PlainTrial

High Grade Glioma

All registered trials for this condition

Solid Tumor, Unspecified, Child

All registered trials for this condition

Arkansas

All trials with a study site in Arkansas

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.