NCT04516447

A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer

A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 172 (estimated)
• Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a Phase 1b open-label, multicenter study evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (also known as ZN-c3) in combination with chemotherapy or bevacizumab. This study consists of 2 parts: Part 1 (completed and no longer recruiting): Azenosertib in combination with chemotherapy Azenosertib was assessed in combination with chemotherapy in subjects with platinum-resistant advanced ovarian, peritoneal, or fallopian tube cancer. Part 2: Azenosertib in combination with bevacizumab * Dose Escalation (completed and no longer recruiting): Azenosertib was assessed in combination with bevacizumab as first-line (1L) or second-line (2L) maintenance therapy in subjects with advanced ovarian, peritoneal, or fallopian tube cancer after platinum-based chemotherapy to determine a recommended dose for expansion. * Dose Expansion: Azenosertib will be assessed in combination with bevacizumab as 2L maintenance therapy in subjects with advanced ovarian, peritoneal, or fallopian tube cancer after platinum-based chemotherapy.

Conditions

• Solid Tumor
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Cancer

Interventions

Type	Name	Description
DRUG	Azenosertib	Investigational drug
DRUG	Carboplatin	Carboplatin is an approved drug
DRUG	Pegylated liposomal doxorubicin	Pegylated liposomal doxorubicin (PLD) is an approved drug
DRUG	Paclitaxel	Paclitaxel is an approved drug
DRUG	Gemcitabine	Gemcitabine is an approved drug
BIOLOGICAL	Bevacizumab	Bevacizumab is an approved drug

Timeline

• Start date: 2020-10-26
• Primary completion: 2028-06-30
• Completion: 2028-06-30
• First posted: 2020-08-18
• Last updated: 2026-04-07

Locations

24 sites across 7 countries: United States, Australia, Bosnia and Herzegovina, Bulgaria, Georgia, Serbia, South Korea

Regulatory

• FDA-regulated drug study