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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
View on ClinicalTrials.gov ↗

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)

Recruiting in Massachusetts

  • Site 0104 · Boston, Suffolk County