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MDM2/MDMX Inhibitor

ALRN-6924 for Brain Tumor

Phase 1
Waitlist Available
Led By David S Shulman, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is studying ALRN-6924 to see how well it works in treating patients with resistant solid tumors, brain tumors, lymphoma, or leukemia.

Eligible Conditions
  • Brain Tumor
  • Leukemia
  • Solid Tumors
  • Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of patients with dose limiting toxicity by CTCAE v.5.0 for each dose level
Percentage of patients with toxicity by CTCAE v.5.0
Secondary outcome measures
Area under the curve (AUC) of ALRN-6924
Objective response rate
Peak plasma concentration of ALRN-6924

Side effects data

From 2021 Phase 2 trial • 50 Patients • NCT03012672
45%
Febrile Neutropenia
25%
Bacteremia
20%
Rash Maculo-Papular
20%
Hypoxia
15%
Tumor Lysis Syndrome
15%
Hyperglycemia
15%
Cardiac Troponin I Increased
10%
Pulmonary Edema
10%
Urinary Tract Infection
10%
Intracranial Hemorrhage
10%
Headache
10%
Edema Limbs, Volume Overload
10%
Delirium
10%
Soft Tissue Infection
10%
COPD Exacerbation
10%
Atrial Fibrillation
10%
Blood Bilirubin Increased
10%
Respiratory Failure
5%
Generalized Edema
5%
Vascular Access Complication
5%
Colonic Pseudo-Obstruction
5%
Acute Kidney Injury
5%
Nausea
5%
Multi-organ failure
5%
Sepsis
5%
Right Ventricular Dysfunction
5%
Alkalosis
5%
Anorexia
5%
Dyspnea
5%
Bronchopulmonary Hemorrhage
5%
Hypotension
5%
Lung Infection
5%
Optic Nerve Disorder
5%
Hypertension
5%
Hypokalemia
5%
Hyponatremia
5%
Paroxysmal Atrial Tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
ARM I (HIGHER-DOSE):
ARM II (LOWER-DOSE):

Trial Design

3Treatment groups
Experimental Treatment
Group I: ALRN-6924 -- Cohort CExperimental Treatment2 Interventions
Patients will receive ALRN-6924 in combination with cytarabine on days 1, 8 (± 1 day), and 15 (± 1 day) of a 28-day cycle. Cytarabine is administered intravenously. ALRN-6924 will be administered intravenously. Participants with TP53 wild type acute leukemia will participate in this cohort.
Group II: ALRN-6924 -- Cohort BExperimental Treatment1 Intervention
Participants will receive ALRN-6924 monotherapy on days 1, 4 (± 1 day), 8 (± 1 day), and 11 (± 1 day) of a 21-day cycle. ALRN-6924 will be administered intravenously. Participants with solid and CNS tumors and lymphoma with specific diagnoses or molecular features will participate in this cohort.
Group III: ALRN-6924 -- Cohort AExperimental Treatment1 Intervention
Participants will receive ALRN-6924 monotherapy on days 1, 4 (± 1 day), 8 (± 1 day), and 11 (± 1 day) of a 21-day cycle. ALRN-6924 will be administered intravenously. Participants with otherwise unselected TP53 wild type solid tumors and lymphoma will participate in this cohort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALRN-6924
2018
Completed Phase 2
~230
Cytarabine
2016
Completed Phase 3
~3310

Find a Location

Who is running the clinical trial?

Cookies for Kids' CancerOTHER
6 Previous Clinical Trials
337 Total Patients Enrolled
Aileron Therapeutics, Inc.Industry Sponsor
5 Previous Clinical Trials
278 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,851 Total Patients Enrolled

Frequently Asked Questions

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

What criteria must prospective participants meet in order to join this clinical investigation?

"This clinical trial seeks 69 individuals with lymphoma, aged one to twenty-one. Meeting the following criteria is essential: Age greater than 1 year and no more than 21 at time of enrollment; having measurable or evaluable disease; being in a relapsed or refractory state where conventional curative treatment has failed ; for Cohort A patients must have histologically confirmed non-CNS primary solid tumors/lymphomas based on biopsy/surgery during diagnosis and relapse/progression (exception applies to those with retinoblastoma)."

Answered by AI

What primary conditions is ALRN-6924 used to address?

"ALRN-6924 has demonstrated efficacy in treating leptomeningeal metastases, and is also a viable option for patients with acute promyelocytic leukemia, meningeal leukemia and blast phase chronic myelocytic leukemia."

Answered by AI

Is this research endeavor being conducted at numerous centers in Canada?

"In addition to the initial sites mentioned, this clinical trial is also being conducted at UCSF Benioff Children's Hospital in San Francisco, California; Children's Hospital of Philadelphia in Philadelphia, Pennsylvania; and Dana-Farber Cancer Institute in Boston Massachusetts."

Answered by AI

What is the current enrollment quota for this clinical trial?

"Aileron Therapeutics, Inc. will be spearheading this clinical trial at various medical centres including the UCSF Benioff Children's Hospital in San Francisco and the Philadelphia-based Children's Hospital of Philadelphia; with a total sample size of 69 participants that meet all necessary requirements for study inclusion."

Answered by AI

Has ALRN-6924 been previously evaluated in any other clinical experiments?

"At present, 234 studies into ALRN-6924 are underway with 60 of those in the final Phase 3. While most testing is being conducted in New york City, trials for this drug span nearly 10,000 locations across the world."

Answered by AI

Are there any available spots left in this clinical trial?

"This trial, initially posted on November 1st 2018 and recently adjusted on June 14th 2022, is actively seeking participants."

Answered by AI

Is ALRN-6924 a risky or secure treatment option?

"Based on the limited data collected, our group at Power has assigned ALRN-6924 a score of 1 for safety since it is still in its initial trial phase."

Answered by AI

Does this medical trial cater to individuals of advanced age?

"As per the study's enrollment criteria, participants must be between 1 and 21 years old to qualify for inclusion."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 1 Study of the Dual MDM2/MDMX Inhibitor ALRN-6924 in Pediatric Cancer
David S Shulman, MD 2018. "Phase 1 Study of the Dual MDM2/MDMX Inhibitor ALRN-6924 in Pediatric Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03654716.
~3 spots leftby Apr 2025
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