Health Trials

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 groups

Locations

24
Australia
Site 27074101, South BrisbaneQueensland, Australia
Site 27084556, Sunshine CoastQueensland, Australia
Site 27095000, AdelaideSouth Australia, Australia
Site 27063144, MelbourneVictoria, Australia

Sponsors and collaborators

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Lead sponsor

Source ClinicalTrials.gov