A Phase 1/2 Research Study for Patients with Ovarian Clear Cell Carcinoma or Endometrial Carcinoma or other Advanced Solid Tumors

IRB/UVA Tracking #
Principal Investigator
Linda R Duska
Anne Gabel
Contact Email
Contact Phone
Official Trial Title
A Phase 1/2 Study of CPI-0209 Monotherapy and in Combination with Other Therapy in Patients with Advanced Solid Tumors
Study Description

The UVA Cancer Center has a clinical trial for adults ages 18 and over who have an advanced relapsed solid tumor, ovarian clear cell carcinoma or endometrial carcinoma. You will be eligible if you have already been treated with standard therapy and your tumor is now growing.

The purpose of Phase 1 portion of the study is to test the safety of the EZH2 inhibitor drug, CPI-0209, and to try to determine the dose of it that would have acceptable side effects and which may be useful in treating people with solid tumors. The Phase 2 part will focus on how selected tumor types respond to CPI-0209 at the recommended Phase 2 dose (as established in Phase 1).

There are two different treatment regimens in this study – monotherapy (treatment with CPI-
0209 alone) and combination therapy (treatment with CPI-0209 plus chemotherapy drug Irinotecan).

The overall trial does not have a set duration, study treatment will continue for as long are your study doctor thinks the medicine is helping you or another reason for discontinuation* has been presented. If you are enrolled on the Phase 2 portion of the study you will be followed for survival approximately every 3 months for up to 24 months from the first dose of study drug or up to 12 months after treatment discontinuation (whichever is longer). Survival status will be collected during the Safety Follow-up via phone call.
*If you discontinue study drug for reasons other than confirmed disease progression you will be followed until your disease gets worse or you start a new anticancer treatment.

Research-specific tests (ECG, tumor biopsy, blood tests) and the administration of study drug (CPI-0209) will be provided at no cost to you. The costs of standard tests, procedures, and treatment of complications will be paid by your insurer in the same way as if you were not part of this study. You may be responsible for any extra costs your insurance company does not pay.

Additional information can be found here: NCT04104776


No compensation, but you will be reimbursed for your travel expenses. You will be reimbursed up to $175 per night for a hotel room and $.54 per mile.