Study of LAM561 Acid in Pediatric Patients With Malignant Glioma and Other Advanced Solid Tumors

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Laminar Pharmaceuticals
Study ID
NCT04299191
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • High-grade Glioma
  • Solid Tumor, Unspecified, Child

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • LAM561 — DRUG
    Once a patient is allocated a dose of LAM561, they will receive the same dose on a daily basis in treatment cycles of 21 days (3 weeks), which may be repeated without therapy interruption until a criterion for discontinuation (clinical or radiological progression of disease, clinically unacceptable toxicity, or another "general" criterion) is met. The starting dose will be 2.8 g/m2 twice daily. If tolerated, doses will be escalated to 3.5 g/m2 twice daily and then to a third dose level of 4.2 g/m2 twice daily. These dose levels correspond to 80%, 100%, and 120% of the maximum tolerated dose of LAM561 in adult patients when adjusted for body surface area. A total of 3 dose cohorts are anticipated for the dose escalation phase of the study, with up to 6 patients enrolled at each dose level according to a standard "3+3" design. During each dose cohort, at least 1 week must elapse between the first and subsequent patients receiving treatment with LAM561.

Study Details

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.

Key Dates

Start date
Sep 1, 2020
Status verified
Nov 2025
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    The dose level corresponds to 80% of the maximum tolerated dose of LAM561 in adult patients when adjusted for body surface area. The escalation will be to the 100%, and 120% of the maximum tolerated dose of LAM561 in adult patients when adjusted for body surface area. Dose escalation decisions will be made by all active Investigators in collaboration with the Medical Monitor when at least three patients have completed the DLT observation period (Cycle 1) at each dose level. When the third patient at any given dose level has received 14 days of therapy, an "escalation teleconference" will be scheduled after that patient has completed the DLT observation period (Cycle 1). The decision to progress to the next dose level will be made on the basis of review of all significant LAM561-related toxicities.

Primary Outcome Measure

Safety and Tolerability of LAM561 [ Time Frame: Between 1 to 6 cycles (each cycle is 3 weeks) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Arkansas Children's Research InstituteLittle RockArkansas72202
Kevin Bielamowicz, MD
[email protected]
Kevin Bielamowicz, MD (PRINCIPAL_INVESTIGATOR)
University of Miami HospitalMiamiFlorida33146
Bradley Gampel, MD (PRINCIPAL_INVESTIGATOR)
Hackensack Meridian Health, IncEdisonNew Jersey08837
Derek Hanson, MD
[email protected]
+1551996542
Derek Hanson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Little Rock, AR

By research site
Arkansas Children's Research Institute· Little Rock, ARUniversity of Miami Hospital· Miami, FLHackensack Meridian Health, Inc· Edison, NJ

Related Studies