Purpose of this Study
We are doing this study to find out if an experimental drug called Rina-S (the study drug) is a safe and effective option for ovarian cancer that is not improving with standard treatments.
Who Can Participate?
Eligibility
Adults ages 18-64 who:
- Are diagnosed with ovarian cancer
- Have already received at least 1 but not more than 4 lines of previous therapy
- Have disease that is not responding adequately to treatment
- Have known or suspected deleterious germline or somatic BRCA mutations
Age Range
18-64
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will go through a screening period to make sure you are eligible. During this period, you will:
- Have a tumor biopsy
- Have a physical exam
- Have blood draws and give urine samples
- Have heart scans (echocardiogram and EKG)
- Have imaging done (CT and/or MRI)
- Paclitaxel, given as an IV infusion on Days 1, 8, and 15 every 4 weeks
- Topotecan, given as an IV infusion on Days 1, 8 and 15 every 4 weeks, or as an IV infusion on Days 1-5 every 3 weeks (the study doctor will decide on the dosing schedule)
- Pegylated liposomal doxorubicin, given as an IV infusion once every 4 weeks
- Gemcitabine, given as an IV infusion on Days 1, 8, and 15 every 4 weeks
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Phase 3 Randomized, Open-label Study of RinatabartSesutecan (Rina-S) versus Treatment of Investigator’s Choice (IC) in Patients with Platinum Resistant Ovarian Cancer
Principal Investigator
Angeles
Secord
Protocol Number
PRO00116690
NCT ID
NCT06619236
Phase
III
Enrollment Status
Open to Enrollment