| ClinicalTrials.gov Identifier |
| NCT05012397 |
| Institution Name |
| MD Anderson Cancer Center |
| Institution City |
| Houston |
| Institution State |
| 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 |
| eeileana@mdanderson.org |
| Study Coordinator |
| Samrina Hussain |
| Study Coordinator Phone |
| (832) 817-8063 |
| Study Coordinator Email |
| sshussain@mdanderson.org |
| 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 |
