Actively Recruiting
Phase I Trial of CPI-0209 Combined With Carboplatin for Platinum Sensitive Recurrent Ovarian Cancer
Led by Lan Coffman · Updated on 2025-06-19
30
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
L
Lan Coffman
Lead Sponsor
N
Novartis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the combination of CPI-0209, a second-generation EZH2 inhibitor, with carboplatin chemotherapy for patients with platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer. This trial aims to improve treatment outcomes, especially for patients who have previously received maintenance therapies like PARP inhibitors or bevacizumab, as there is a need for better approaches to enhance platinum chemotherapy response and delay disease progression. Participants will receive CPI-0209 orally at doses of 100 mg or 150 mg alongside carboplatin administered intravenously according to institutional standards. The study includes an initial treatment phase with this combination and a maintenance phase with CPI-0209 to assess safety, tolerability, and effectiveness in prolonging the disease-free interval. Throughout the trial, participants will be monitored for the maximum tolerated dose of CPI-0209 over up to 24 months, as well as adverse events, overall response, and progression-free survival for up to 5.5 years. Regular assessments include clinical evaluations, laboratory tests, and imaging to document disease status and safety. Participants will be followed closely to evaluate treatment effects and manage any side effects during and after therapy.
CONDITIONS
Brief Title
CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer (recurrence more than 6 months after last platinum chemotherapy) eligible for platinum chemotherapy
- Documented disease recurrence or progression based on GCIG-RECIST criteria
- At least one prior line of platinum-based therapy; prior bevacizumab or PARP inhibitor use allowed
- ECOG performance status 0-2 with life expectancy of at least 3 months
- Adequate organ function including creatinine, liver enzymes, bilirubin, blood counts, INR, and electrolytes
- Ability to swallow CPI-0209 tablets or oral suspension
- Able to consent and comply with study protocol
- Treated CNS metastases allowed if stable and asymptomatic off corticosteroids for specified periods
- Women of child-bearing potential must use highly effective contraception or abstain from vaginal intercourse for at least 183 days after treatment
You will not qualify if you...
- Borderline or low malignant potential tumor histology
- Platinum-resistant disease (progression within 6 months of platinum chemotherapy)
- Known allergy to CPI-0209 excipients
- Gastrointestinal issues affecting drug absorption
- Concurrent malignancy within 3 years except certain treated skin or cervical cancers
- History of HIV infection
- Active infections requiring systemic treatment
- Severe or uncontrolled medical conditions posing safety risks
- Current use of warfarin or coumadin-derived anticoagulants
- Use of herbal supplements not discontinued 7 days before study
- Consumption of foods strongly affecting CYP3A4/5 metabolism not discontinued
- Pregnant or breastfeeding
- Recent investigational drug use within 30 days or 5 half-lives
- Recent radiotherapy or limited field radiation with unresolved side effects
- Recent major surgery or unresolved side effects
- Unresolved toxicities from prior therapies above specified grades
- Grade 3 baseline neuropathy
- Child-Pugh score B or C liver disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants receive oral CPI-0209 combined with intravenous carboplatin chemotherapy as per institutional standards to enhance ovarian cancer sensitivity to platinum-based therapy.
Visits scheduled as per chemotherapy cycles and study protocol
Duration - Up to 5.5 years
Participants are monitored for adverse events, overall response, and progression-free survival after completing treatment.
Periodic visits for ongoing assessments
Trial Site Locations
Total: 1 location
1
Magee-Womens Research Institute / UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
K
Kelsey Mitch, RN
J
Joshua Plassmeyer, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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