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NCT Number: NCT04833582

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

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.

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Key information

Conditions

Osteosarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Sarcoma

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site 3604, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 of strong and moderate CYP3A4 inhibitors/inducers and strong and moderate P-gp inhibitors.

Treatment and study plan

Azenosertib

Drug

Azenosertib is an investigational drug.

Other names: ZN-c3

Gemcitabine

Drug

Gemcitabine is an approved drug

Other names: Gemzar

Primary outcomes

  1. Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events.

    Time frame: 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.

    Time frame: During phase 2, at 18 weeks

    EFS at 18 weeks is defined as time from study enrollment until date of disease progression, or detection of disease at a previously uninvolved site, or date of death of the subjects at 18 weeks.

Secondary outcomes

  1. Event-free survival (EFS) per RECIST Guideline version 1.1.

    Time frame: At 12 months

    EFS is defined as time from study enrollment until date of last contact, date of disease progression, or detection of disease at a previously uninvolved site, or date of death.

  2. Median overall survival (OS) and OS at 12 months per RECIST Guideline version 1.1.

    Time frame: At 12 months

    OS is defined as the time from date of first dosing until the date of death.

  3. The frequency and severity of adverse events (AEs) and laboratory abnormalities per the National Cancer Institute Common Terminology (NCI CTCAE) version 5.0.lities.

    Time frame: Through completion, approximately 42 months

  4. Plasma pharmacokinetics (PK) maximum concentration (Cmax).

    Time frame: Through completion, approximately 42 months

  5. Plasma PK time to maximum concentration (Tmax).

    Time frame: Through completion, approximately 42 months

  6. Area under the plasma concentration versus timepoint curve (AUC last).

    Time frame: Through completion, approximately 42 months

  7. Terminal half-life of the plasma PK concentration.

    Time frame: Through completion, approximately 42 months

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Apr 6, 2021
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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