A Research Study for Adult Women with Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer

UVA Tracking #
Principal Investigator
Linda R Duska
Anne Gabel
Contact Email
Contact Phone
Official Trial Title
A Phase I/Ib Dose Escalation Study of Pegylated Liposomal Doxorubicin (PLD) With M3814 in Platinum-Resistant or Ineligible Ovarian and Related Cancers with Planned Expansions in High Grade Serous (HGSOC) and Low Grade Serous Ovarian Cancer (LGSOC)
Study Description

The UVA Cancer Center seeks women ages 18 and over who have recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer for a clinical trial. This includes the following histologic types: serous adenocarcinoma (Grade 1, 2, or 3/ high grade or low grade), endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial adenocarcinoma, transitional cell carcinoma, or adenocarcinoma not otherwise specified.

The purpose of the Phase 1 Dose Escalation part of this study is to look at the safety and tolerability (side effects) of the combined treatment of the study drug, peposertib (M3814), and concurrent pegylated liposomal doxorubicin chemotherapy in women with platinum-resistant ovarian and related cancers. The Phase 1B Expansion part will further test the safety of the best dose determined in the Phase 1 dose escalation cohort. During the study, research-specific blood samples will be taken to determine the amount of time the study drugs remain in your system. Also, research-specific tests will be performed on tumor tissue available from previous biopsies to see if any changes (mutations) can predict how you will respond to treatments.

The overall trial does not have a set duration, study treatment will continue for as long as your study doctor thinks the medicine is helping you or another reason for discontinuation has been presented. Patients will be followed for safety for 30 days following discontinuation of study drug. Patients who discontinue treatment before their cancer progresses will be asked to continue to have imaging performed every 2 or 3 months until the time of progression.

If eligible and you choose to participate, the research-specific blood and tissue tests and the study drug, peposertib, will be provided at no cost to you. You or your insurance company are responsible for the cost of getting the peposertib ready and giving it to you, as well as all other exams, drugs, scans, procedures, clinical visits, travel costs, etc.

Additional information can be found here: NCT04092270