A Study of Azenosertib (ZN-c3) in Combination With Gemcitabine in Subjects With Osteosarcoma (NCT04833582) | Clinical Trial Compass
CompletedPhase 1
A Study of Azenosertib (ZN-c3) in Combination With Gemcitabine in Subjects With Osteosarcoma
United States31 participantsStarted 2021-08-01
Plain-language 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.
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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 …
What they're measuring
1
Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events.
Timeframe: Through Cycle 1 (21 days) Phase 1
2
Event-free survival (EFS) at 18 weeks per RECIST (Response Evaluation Criteria in Solid Tumors) Guideline version 1.1.
Timeframe: During phase 2, at 18 weeks
Trial details
NCT IDNCT04833582
SponsorK-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc