CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer (NCT05942300) | Clinical Trial Compass
RecruitingPhase 1
CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer
United States30 participantsStarted 2024-01-30
Plain-language summary
This is a clinical trial using CPI-0209 in combination with Carboplatin chemotherapy followed by CPI-0209 maintenance in patients with platinum sensitive, recurrent ovarian cancer.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer (defined as recurrent disease \> 6 months after completing last platinum- based chemotherapy) that are eligible to receive platinum-based chemotherapy).
* Documented disease recurrence/progression based on GCIG-RECIST
* Must have had at least 1 prior line of platinum-based therapy, prior bevacizumab or PARPi use are allowed. Women with germline BRCA mutations should be considered for PARPi maintenance as standard of care treatment prior to consideration of clinical trial enrollment
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 with life expectancy of ≥ 3months
* Adequate organ function
* Serum creatinine ≤1.5mg/dL or 24-hour clearance ≥50mL/min
* AST/ALT \<2.5x ULN (or \<5x ULN if liver metastasis are present)
* Total bilirubin ≤ ULN or total bilirubin ≤3.0 x ULN or direct bilirubin ≤1.5 x ULN in patients with well-documented Gilbert's Syndrome
* Hemoglobin ≥9 gm/dl, Platelets ≥100,000/μl ANC ≥1500/μl
* INR ≤1.5
* Potassium, total calcium (corrected for serum albumin), magnesium, and sodium within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication
* Must be able to swallow CPI-0209 tablet/oral suspension
* Able to provide informed consent and comply with all study protocol
* Treated CNS metastasis allowed if treatment is completed ≥8 weeks prior to enrollme…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.