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LAM561 for Pediatric Brain Tumor

Q: What is the aggregate headcount of people involved in this medical investigation?

<p>Affirmative. According to clinicaltrials.gov, this investigation is actively recruiting volunteers and was first posted on September 1st 2020. Currently, 18 participants are needed from a single site for the trial's completion.</p>

Q: Are there any openings left to participate in this research trial?

<p>Affirmative. According to clinicaltrials.gov, this study is currently looking for 18 individuals at a single location. This program was initially posted on September 1st 2020 and the most recent edit happened in August 16th 2022.</p>

Phase 1 & 2

Recruiting

Research Sponsored by Laminar Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

or a serum creatinine less than or equal to the institutional normal for age

Age <18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during cycles 1 (days 1, 8 and 15) and 2 (day 1) (each cycle is 3 weeks) and at the end of study visit (30 days of the last lam561 dose)

Awards & highlights

Study Summary

This trial is looking at a new treatment for pediatric patients with brain tumors. The treatment will be given in two phases, with the first phase looking at the safety of the treatment and the second phase looking at how well the treatment works.

Who is the study for?

This trial is for children under 18 with advanced high-grade gliomas or other solid tumors that are getting worse, coming back, or not responding to standard treatments. They must be able to take oral medication and have good enough blood counts and organ function. Kids who can't walk due to paralysis but use a wheelchair can join too.Check my eligibility

What is being tested?

The study tests LAM561 in two parts: first, finding the highest dose kids can handle without serious side effects (dose escalation), then giving more kids this dose to make sure it's safe (expanded safety cohort). It's an open-label trial, meaning everyone knows they're getting LAM561.See study design

What are the potential side effects?

Possible side effects of LAM561 aren't listed here, but since there's a phase focused on finding the maximum tolerated dose without severe side effects, these could include typical chemotherapy-related issues like nausea, fatigue, lowered immunity leading to infections and potential impact on growth in children.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by creatinine, is within the normal range for my age.

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I am under 18 years old.

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My heart's electrical activity is normal, with no QTc prolongation.

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My liver enzyme levels are within the normal range.

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My cancer is advanced, getting worse, and standard treatments haven't worked or aren't available.

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I do not have a bleeding disorder.

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My bilirubin levels are within the normal range for my age.

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I can take pills by mouth or have a tube for medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during cycles 1 (days 1, 8 and 15) and 2 (day 1) (each cycle is 3 weeks) and at the end of study visit (30 days of the last lam561 dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during cycles 1 (days 1, 8 and 15) and 2 (day 1) (each cycle is 3 weeks) and at the end of study visit (30 days of the last lam561 dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during cycles 1 (days 1, 8 and 15) and 2 (day 1) (each cycle is 3 weeks) and at the end of study visit (30 days of the last lam561 dose) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and Tolerability of LAM561

To identify the Recommended Phase 2 Dose (RP2D) of LAM561 in pediatric patients

Secondary outcome measures

Characterize LAM561 PK profile

To assess the preliminary anti-tumor efficacy of LAM561

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LAM561

2018

Completed Phase 2

~80

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER

1,079 Previous Clinical Trials

340,962 Total Patients Enrolled

Laminar PharmaceuticalsLead Sponsor

3 Previous Clinical Trials

212 Total Patients Enrolled

Laminar Pharma IncUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate headcount of people involved in this medical investigation?

"Affirmative. According to clinicaltrials.gov, this investigation is actively recruiting volunteers and was first posted on September 1st 2020. Currently, 18 participants are needed from a single site for the trial's completion."

Answered by AI

Are there any openings left to participate in this research trial?

"Affirmative. According to clinicaltrials.gov, this study is currently looking for 18 individuals at a single location. This program was initially posted on September 1st 2020 and the most recent edit happened in August 16th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Study of LAM561 Acid in Pediatric Patients With Malignant Glioma and Other Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04299191.