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Phase 1 Study of the Dual MDM2/MDMX Inhibitor ALRN-6924 in Pediatric Cancer

NCT03654716 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-02-14

No results posted yet for this study

Summary

This research study is studying a novel drug called ALRN-6924 as a possible treatment for resistant (refractory) solid tumor, brain tumor, lymphoma or leukemia.

The drugs involved in this study are:

* ALRN-6924
* Cytarabine (for patients with leukemia only)

Conditions

Interventions

DRUG

ALRN-6924

ALRN-6924 is a drug that blocks certain proteins in tumor cells called MDM2 and MDMX. These proteins may be important in the growth of some cancers. Laboratory experiments and results from studies with adults show that ALRN-6924 may stop tumor growth and, in some cases, may cause tumor cells to die.

DRUG

Cytarabine

Cytarabine belongs to the category of chemotherapy called antimetabolites. Antimetabolites are very similar to normal substances within the cell. When the cells incorporate these substances into the cellular metabolism, they are unable to divide

Sponsors & Collaborators

  • TeamConnor Childhood Cancer Foundation

    collaborator UNKNOWN

  • Cookies for Kids' Cancer

    collaborator OTHER

  • Aileron Therapeutics, Inc.

    collaborator INDUSTRY

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • David S Shulman, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2023-07-17
Completion
2023-07-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03654716 on ClinicalTrials.gov