CPI-0209 Plus Carboplatin for Recurrent Ovarian Cancer
This study is testing a new combination treatment for recurrent ovarian cancer that has responded to platinum-based chemotherapy in the past. You might be able to join if you are a woman aged 18 or older with recurrent ovarian, fallopian, or primary peritoneal cancer that came back more than 6 months after your last platinum-based chemotherapy. The study combines CPI-0209, a drug designed to target cancer cells, with carboplatin, a standard chemotherapy drug. After initial treatment, you would continue with CPI-0209 alone. The main goal is to find the highest safe dose of CPI-0209 when given with carboplatin. The study is currently recruiting about 30 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It involves about 30 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The maximum tolerated dose of CPI-0209 will be measured for up to 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05942300
CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentLan CoffmanInvestigator-initiated
~30 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:CPI-0209carboplatin
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD) of CPI-0209
Measured over Up to 24 months
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
Study leadership
- Lan Coffman, MD, PhD · PRINCIPAL_INVESTIGATOR · UPMC Magee Women's Hospital
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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 enrollment. Patients must be asymptomatic off systemic corticosteroids for at least 4 weeks after completion of radiation therapy. CNS disease must be stable or regressed on repeat imaging performed at least 4 weeks after completion of therapy.
Women of child-bearing potential (those who have had a menstrual cycle within the last year and have not had a tubal ligation or surgical removal of both ovaries and/or hysterectomy) must agree to abstain from vaginal intercourse or use and continue highly effective methods of contraception for at least 183 days after discontinuation of study treatment.
Total abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment.
Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that patient.
Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception.
In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
Exclusion
Borderline or low malignant potential histology
Platinum-resistant disease (as defined as progressive disease (PD) within 6 months of completion of chemotherapy with a platinum agent).
Known hypersensitivity to any of the excipients of CPI-0209.
Gastrointestinal (GI) dysfunction or disease that may significantly alter the absorption of the study drugs
Concurrent malignancy or malignancy within 3 years prior to starting study drug with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer or per physician discretion that the previous cancer was adequately treated with curative intent and unlikely to recur (the study PI must concur with this determination).
History of HIV infection
Has an active infection requiring systemic treatment
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks and contraindicate patient's participation in the clinical study or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, significant cardiac/pulmonary disease etc.)
Patient is currently receiving warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed.
Use of herbal supplements unless discontinued ≥7 days prior to initiation of study drug
Consumption of foods which are strong inducers or inhibitors of CYP3A4/5 has to be discontinued 7 days prior to initiation of study drug. Patients that are unwilling to exclude Seville oranges, grapefruit juice, AND grapefruit from the diet and all foods that contain those fruits from time of enrollment to through the duration of study participation will be excluded.
Pregnant or breast feeding
Participation in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer
Patient who has received radiotherapy ≤4 weeks or limited field radiation for palliation ≤2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom ≥25% of the bone marrow (Ellis, 1961) was irradiated.
Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered as major surgery).
Patient has not recovered from all toxicities related to prior anticancer therapies to NCI-CTCAE version 5 Grade ≤1 (Exception to this criterion: patients with any grade of alopecia, controlled endocrine toxicities and/or neuropathy ≤ grade 2 are allowed to enter the study).
Grade 3 baseline neuropathy
Patient with a Child-Pugh score B or C.
What this trial measures
- Maximum tolerated dose (MTD) of CPI-0209Up to 24 months
MTD will be determined via Dose-limiting toxicity (DLT)s defined as any grade 3-4 non-hematological or grade 4 hematological toxicity at least possibly related to the treatment, occurring during the first two cycles of treatment and per Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events (CTCAE) version 5.