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A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma
This is a Phase 2 study to evaluate the clinical activity and safety of ZN-c3 (azenosertib) in adult women with recurrent or persistent uterine serous carcinoma (USC).
Study details:
This is a Phase 2 open-label, multicenter study to evaluate the clinical activity and safety of ZN-c3 (also known as azenosertib; KP-2638) in adult women with recurrent or persistent uterine serous carcinoma (USC).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: Female
Things to know
Study dates
Study start: 2021-07-28
Primary completion: 2024-11-30
Study completion finish: 2025-05-31
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT04814108
Intervention or treatment
DRUG: ZN-c3
Conditions
- • Uterine Serous Carcinoma
Find a site
Closest Location:
Concord Repatriation General Hospital
Research sites nearby
Select from list below to view details:
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Cabrini Hospital Malvern
Malvern, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: ZN-c3 Single Agent
| DRUG: ZN-c3
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Frequency and severity of TEAEs and incidence of dose modifications | To determine the safety and tolerability of ZN-c3 in subjects with recurrent or persistent USC. | 2 years |
Objective Response Rate as defined by the revised RECIST v1.1 as assessed by ICR | To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC | 2 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Objective Response Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator. | To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules | 2 years |
Duration of Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator. | To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules | 2 years |
Progression Free Survival as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator. | To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules | 2 years |
Clinical Benefit Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator. | To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules | 2 years |
Time To Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator. | To investigate the antitumor activity of ZN-c3 in subjects with recurrent or persistent USC at different doses/schedules | 2 years |
Frequently Asked Questions
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