A Phase 2 Basket Study of Milademetan in Advanced/Metastatic Solid Tumors

ClinicalTrials.gov Identifier

NCT05012397

Institution Name

MD Anderson Cancer Center

Full Institution Address

Houston Texas

Additional Institutions

Stanford University Medical Center, Palo Alto CA Massachusetts General Hospital, Boston MA Dana-Farber Cancer, Boston MA Washington University School of Medicine, St Louis MO Memorial Sloan Kettering Cancer Center, NY NY Duke University Medical Center, Durham NC Tennessee Oncology, Nashville TN Florida Cancer Specialists, Fort Myers FL Florida Cancer Specialists, St Petersburg FL

Principal Investigator

Cathy Dumbrava

Principal Investigator Phone

(281) 876-7428

Principal Investigator Email

[email protected]

Study Coordinator

Samrina Hussain

Study Coordinator Phone

(832) 817-8063

Study Coordinator Email

[email protected]

Study Overview

Milademetan belongs to a new class of drugs called MDM2 inhibitors which restore the function of TP53, an important gene which helps control cell growth. In cancers, too much MDM2 can block normal TP53 function and contribute to cancer growth. This study tests milademetan, a pill therapy, as treatment for cancers which have too much MDM2.

Enrollment Information

NA

Study Start Date

20211111

Study End Date

20240830

Study Purpose

Restoration of TP53 tumor suppressor gene function in cancer patients with excess MDM2 gene activity Normal TP53 helps control cell growth and is balanced by MDM2 activity In cancers, excess MDM2 can reduce/inhibit normal TP53 gene function which contributes to abnormal cancer cell growth Too many gene copies (gene amplification) of MDM2 is one way cancer cells create excess MDM2 activity Milademetan is a pill inhibitor of excess MDM2 activity and can restore normal TP53 gene function

Inclusion Criteria

Have a solid tumor which is regrown after locally surgery or radiation, or has spread to other organs Have received all appropriate treatment or unlikely to benefit from usual available therapy Have a tumor test or blood test that shows MDM2 gene amplification Be age 18 and older Have good bone marrow, liver and kidney functions when measured by blood tests

Exclusion Criteria

Have a diagnosis of leukemia, lymphoma, liposarcoma, intimal sarcoma, or primary brain tumor Have tumor in the brain which has not been treated or is not controlled Have infection with HIV, Hepatitis B or Hepatitis C Have significant heart disease history Have prior experimental therapy with other MDM2 inhibitors

Required Tests Prior to Study

Tests of blood to measure bone marrow, liver and kidney function Scans (CT or MRI) of areas of the body where cancer may be active

Potential Side Effects

low blood counts nausea diarrhea tiredness decreased appetite

Financial Assistance Available

Yes

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