What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Azenosertib, Carboplatin, or Pegylated liposomal doxorubicin. The registry lists allocation as randomized. 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.
They plan to enroll about 172 people at 35 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.
Official title (unrewritten)
A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer
Interventions: Azenosertib, Carboplatin, Pegylated liposomal doxorubicin, Paclitaxel, Gemcitabine, Bevacizumab
Primary outcome (registry wording): Part 1: To investigate the safety and tolerability of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Women only
- 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
- For Part 2 Dose Escalation:
- Subjects must have received 6 cycles of platinum-based doublet chemotherapy in the 1L or 2L setting as their most recent therapy
- Response to prior platinum therapy:
- In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy
Who the registry excludes
- 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
- Additional protocol-defined