Status:
UNKNOWN
A Study of ZN-c3 in Combination With Gemcitabine in Subjects With Osteosarcoma
Lead Sponsor:
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Conditions:
Osteosarcoma
Eligibility:
All Genders
12+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase 1/2 study of 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 ZN-c3 in combination with gemcitabine in relapsed o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04833582
Start Date
August 1 2021
End Date
December 30 2023
Last Update
November 14 2023
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Site 0106
Los Angeles, California, United States, 90095
2
Site 0124
Oakland, California, United States, 94609
3
Site 0195
Santa Monica, California, United States, 90403
4
University of Florida College of Medicine
Gainesville, Florida, United States, 32610