ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma
Status:
Completed
Trial end date:
2021-10-07
Target enrollment:
Participant gender:
Summary
Background:
The new drug ONC201 have been shown to kill breast cancer and endometrial cancer cells in the
laboratory. The exact mechanism of action is not completely clear yet, but the ONC201
destroys the mitochondria inside the cells. Blocking mitochondrial activity may kill tumor
cells, which would shrink tumors. Researchers want to see if ONC201 helps shrink tumors of
certain breast or endometrial cancers and if that effect is maintained.
Objective:
To see if ONC201 shrinks tumors with a lasting effect.
Eligibility:
Adults ages 18 and older who have metastatic breast cancer (hormone-positive or
triple-negative) or metastatic endometrial cancers.
Design:
Participants will be screened with:
Medical history
Physical exam
Heart, blood, and urine tests
CT and bone scans
Review of medical report and tumor sample
Participants will have a tumor biopsy before starting treatment and after 5 weeks taking the
study drug. A scan or ultrasound may be used to guide the biopsy. Patients will receive local
anesthetic and a needle will remove a small piece of tumor.
The study will be done in 28-day cycles. Every day 1 of each cycle participants will repeat
most screening tests, will be seen by the physician and receive a supply of the study drug.
Participants will take the study drug by mouth once every 7 days. They will keep a diary of
when they take the drug and any side effects. During cycle 1, participants will get weekly
calls to discuss their health and symptoms. Images will be repeated every 2 cycles to
evaluate reponse to the treatment.
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