A Study of ZN-c3 in Combination With Gemcitabine in Subjects With Osteosarcoma
NCT ID: NCT04833582
Last Updated: 2023-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
84 participants
INTERVENTIONAL
2021-08-01
2023-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Combination ZN-c3 with Gemcitabine
ZN-c3
ZN-c3 is an investigational drug.
Gemcitabine
Gemcitabine is an approved drug
Interventions
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ZN-c3
ZN-c3 is an investigational drug.
Gemcitabine
Gemcitabine is an approved drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
12 Years
ALL
No
Sponsors
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K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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ZN-c3-003
Identifier Type: -
Identifier Source: org_study_id
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