NCT04833582

A Study of Azenosertib (ZN-c3) in Combination With Gemcitabine in Subjects With Osteosarcoma

A Phase 1/2 Dose Escalation and Dose Expansion Study of ZN-c3 in Combination With Gemcitabine in Adult and Pediatric Subjects With Relapsed or Refractory Osteosarcoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1/2 study of azenosertib (ZN-c3) in combination with gemcitabine in adult and pediatric subjects with relapsed or refractory osteosarcoma.

Detailed description

This is a phase 1/2 dose escalation and dose expansion study, evaluating the clinical activity and safety, pharmacodynamics, and pharmacokinetics of azenosertib (ZN-c3) in combination with gemcitabine in relapsed or refractory osteosarcoma.

Conditions

• Osteosarcoma

Interventions

Type	Name	Description
DRUG	Azenosertib	Azenosertib is an investigational drug.
DRUG	Gemcitabine	Gemcitabine is an approved drug

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-08-30
• Completion: 2024-03-30
• First posted: 2021-04-06
• Last updated: 2026-04-03

Locations

17 sites across 2 countries: United States, France

Regulatory

• FDA-regulated drug study