Trial NCT04516447
A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer
- Phase
- Phase 1
- Sponsor
- K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
- Conditions
- Solid Tumor; Epithelial Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
INCLUSION CRITERIA:
For Part 1:
* 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:
Prior therapy:
• 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:
1. In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.
2. In the 2L setting:
1. Progressive Disease >183 days after receiving the last dose of platinum chemotherapy in the 1L setting,
2. Complete Response, Partial Response, or Stable Disease to 2L platinum-based chemotherapy.
* Adequate hematologic, and organ function
For Part 2 Dose Expansion:
* Subjects must have at least 4 cycles of platinum-based chemotherapy in 2L and have Complete Response, Partial Response, or Stable Disease
* Subjects must have progressed while on a PARP inhibitor for 1L maintenance Additional protocol-defined inclusion criteria may apply
EXCLUSION CRITERIA:
* 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.Prior malignancy
Additional protocol-defined exclusion criteria may apply
Restrictions found (1)
- Prior malignancyConditionalexclusionShow in the text
Recruiting in Massachusetts
- Site 0104 · Boston, Suffolk County