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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04833582
Other study ID # ZN-c3-003
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date August 1, 2021
Est. completion date December 30, 2023

Study information

Verified date November 2023
Source K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 or refractory osteosarcoma.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 84
Est. completion date December 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ZN-c3
ZN-c3 is an investigational drug.
Gemcitabine
Gemcitabine is an approved drug

Locations

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

Sponsors (1)

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

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of dose-limiting toxicities (DLT) in DLT evaluable subjects and the incidence and severity of adverse events. Through Cycle 1 (21 days) Phase 1
Primary Event-free survival (EFS) at 18 weeks per RECIST (Response Evaluation Criteria in Solid Tumors) Guideline version 1.1. 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. During phase 2, at 18 weeks
Secondary Event-free survival (EFS) per RECIST Guideline version 1.1. 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. At 12 months
Secondary Median overall survival (OS) and OS at 12 months per RECIST Guideline version 1.1. OS is defined as the time from date of first dosing until the date of death. At 12 months
Secondary The frequency and severity of adverse events (AEs) and laboratory abnormalities per the National Cancer Institute Common Terminology (NCI CTCAE) version 5.0.lities. Through completion, approximately 42 months
Secondary Plasma pharmacokinetics (PK) maximum concentration (Cmax). Through completion, approximately 42 months
Secondary Plasma PK time to maximum concentration (Tmax). Through completion, approximately 42 months
Secondary Area under the plasma concentration versus timepoint curve (AUC last). Through completion, approximately 42 months
Secondary Terminal half-life of the plasma PK concentration. Through completion, approximately 42 months
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