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 range18 Years
SexFEMALE
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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…