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

Study Name
	A Phase 2 Basket Study of Milademetan in Advanced/Metastatic Solid Tumors
ClinicalTrials.gov Identifier (if applicable)
	NCT05012397
Clinical Trial Category (check all that apply)
	Beyond First Line Therapy Targeted Therapy Other Novel Therapy
Study Center
Institution Name
	MD Anderson Cancer Center
City
	Houston
State
	Texas
Country
	United States
List additional Institutions (include address, phone number, and website)
	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
Study Contacts
Principal Investigator
	Cathy Dumbrava
P.I. Phone
	(281) 876-7428
P.I. Email
	eeileana@mdanderson.org
Study Coordinator
	samrina hussain
Study Coordinator Phone
	(832) 817-8063
Study Coordinator Email
	sshussain@mdanderson.org
OVERVIEW – in layman’s terms (150 words max)
	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
	NA
Study Start Date
	11/01/2021
Estimated Completion Date
	08/30/2024
Purpose of the Study – in Layman’s Terms (use the “+” to add more list items)
	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 – Patients Must:
	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 – Patients Must NOT:
	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 BEGINNING STUDY TREATMENT – in layman’s terms
	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 – in layman’s terms
	low blood counts nausea diarrhea tiredness decreased appetite