Recurrent Ovarian Cancer study: CPI-0209 vs Carboplatin
Official title CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer
ClinicalTrials.gov ID: NCT05942300
What this study is testing
What is CPI-0209?
An investigational oral medicine being studied for recurrent ovarian cancer. It is designed to inhibit EZH2, a protein that can influence cancer cell growth.
Also referred to as Tulmimetostat.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see how well CPI‑0209 works with Carboplatin and then as a maintenance therapy in patients whose ovarian cancer returns after platinum‑based treatment.
- Who it's for
- It is looking for adults with recurrent ovarian cancer that is sensitive to platinum drugs.
- What's involved
- Participants will receive CPI‑0209 together with Carboplatin chemotherapy, then continue with CPI‑0209 alone as maintenance. They will have regular clinic visits and blood tests.
- Time commitment
- The trial lasts several months, with multiple scheduled visits for treatment and monitoring.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients with platinum-sensitive recurrent ovarian, fallopian or primary peritoneal cancer (defined as recurrent disease \> 6 months after completing...
- 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.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 with life expectancy of ≥ 3months
- Adequate organ function
You likely can't join if
- 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...
- History of HIV infection
See the full eligibility criteria
Who can join
- 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...
- 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.
- 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.
- 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...
- 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...
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment.
- 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 how well it...
- 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.
What rules you out
- 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...
- 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...
- 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.
- 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...
- 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...
- Grade 3 baseline neuropathy
- Patient with a Child-Pugh score B or C.
The study team makes the final eligibility decision.
Where it is enrolling
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.