Ignite Creation Date:
2024-05-06 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03654716
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2018-08-29
Brief Title:
Phase 1 Study of the Dual MDM2MDMX Inhibitor ALRN-6924 in Pediatric Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase 1 Study of the Dual MDM2MDMX Inhibitor ALRN-6924 in Pediatric Cancer
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
The drugs involved in this study are
ALRN-6924
Cytarabine for patients with leukemia only
Detailed Description:
This research study is a Phase I clinical trial which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies Investigational means that the intervention is being studied
In this research study the investigators are evaluating a new drug ALRN-6924 as a potential new treatment for children with cancer
The FDA the US Food and Drug Administration has not approved ALRN-6924 as a treatment for any disease
This is the first time that ALRN-6924 will be studied in children
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 ALRN-6924 has been tested in adults with cancer to find out about side effects and dosing in adults
The purposes of this study are
to evaluate side effects of ALRN-6924 and to find the best dose of ALRN-6924 when used in children
to determine whether this drug may have benefits against the types of cancer seen in children
to see how the body breaks down ALRN-6924 by measuring the amount of ALRN-6924 in the blood
One part of the study is for children with solid tumors lymphoma and brain tumors Cohorts A or B Another part of this study is for children with leukemia Cohort C
In this research study the investigators are evaluating a new drug ALRN-6924 as a potential new treatment for children with cancer
The FDA the US Food and Drug Administration has not approved ALRN-6924 as a treatment for any disease
This is the first time that ALRN-6924 will be studied in children
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 ALRN-6924 has been tested in adults with cancer to find out about side effects and dosing in adults
The purposes of this study are
to evaluate side effects of ALRN-6924 and to find the best dose of ALRN-6924 when used in children
to determine whether this drug may have benefits against the types of cancer seen in children
to see how the body breaks down ALRN-6924 by measuring the amount of ALRN-6924 in the blood
One part of the study is for children with solid tumors lymphoma and brain tumors Cohorts A or B Another part of this study is for children with leukemia Cohort C
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None