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

Completed · Phase 1

Conditions studied: Osteosarcoma

In brief

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.

Key facts

Study ID

NCT04833582

Run by

K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

People needed

31

Starts

2021-08-01

Expected to finish

2024-03-30

Last updated by the study team

2026-04-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 12 years at the time of informed consent
• Bodyweight ≥ 40 kg
• Histologically documented relapsed or metastatic osteosarcoma.
• Must have measurable disease according to RECIST Guideline version 1.1 criteria.
• Adequate hematologic and organ function.
• Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception per institutional standard prior to the first dose and for 6 months after study treatment discontinuation.
• Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if…

• Unresolved toxicity of Grade >1 attributed to prior therapies (excluding: Grade ≤2 neuropathy, alopecia, or skin pigmentation)
• Prior therapy with a WEE1 inhibitor
• A serious illness or medical condition(s).
• Pregnant or lactating females. Females of childbearing potential with a positive serum pregnancy test <14 days to Day 1.
• Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.
• 12-lead ECG demonstrating a corrected QT interval using Fridericia's formula (QTcF) of >470 ms, except for subjects with atrioventricular pacemakers or other conditions (e.g., right bundle branch block) that render the QT measurement invalid.
• History or current evidence of congenital or family history of long QT syndrome or Torsades de Pointes (TdP).
• Taking medications with a known risk of TdP.
• Administration of strong and moderate CYP3A4 inhibitors/inducers and strong and moderate P-gp inhibitors.

Where it is running

• Site 0106 — Los Angeles, California, United States
• Site 0124 — Oakland, California, United States
• Site 0195 — Santa Monica, California, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• Site 0105 — New York, New York, United States
• Site 0107 — Cincinnati, Ohio, United States
• Site 0123 — Portland, Oregon, United States
• Site 0193 — Memphis, Tennessee, United States
• Site 0197 — Nashville, Tennessee, United States
• Site 0103 — Houston, Texas, United States
• Site 0188 — Richmond, Virginia, United States
• Site 0122 — Seattle, Washington, United States
• Site 3604 — Bordeaux, France
• Site 3601 — Lyon, France
• Site 3602 — Marseille, France
• Site 3606 — Paris, France
• Site 3605 — Toulouse, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.