A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorK-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
About this trial
This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.
Eligibility criteria
Qualifiers
Histologically or cytologically confirmed FIGO Stage III/IV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma.
Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting. At least one regimen must have contained cisplatin or carboplatin.
The disease must be platinum resistant (ie, the PFI must have been < 6 months). Platinum refractory disease (ie, PD during first-line platinum-based therapy) is allowed.
In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.
Disqualifiers
Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.
Subjects with carcinosarcomas (even if there is a serous component)
A serious illness or medical condition(s)
Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
Trial design
Treatments tested in this trial
- Azenosertib
- Carboplatin
- Pegylated liposomal doxorubicin
- Paclitaxel
- Gemcitabine
- Bevacizumab
Treatment groups
172 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov