CPI-0209 Plus Carboplatin in Patients With Platinum Sensitive Recurrent Ovarian Cancer
ConditionRecurrent Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLan Coffman
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CPI-0209
- carboplatin
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Lan Coffman
Lead sponsor
University of Pittsburgh
Sponsor institution
Novartis Pharmaceuticals
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov