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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04814108




Registration number
NCT04814108
Ethics application status
Date submitted
18/03/2021
Date registered
24/03/2021
Date last updated
25/06/2024

Titles & IDs
Public title
A Study of ZN-c3 in Women With Recurrent or Persistent Uterine Serous Carcinoma
Scientific title
A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN-c3 in Adult Women With Recurrent or Persistent Uterine Serous Carcinoma
Secondary ID [1] 0 0
ZN-c3-004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Uterine Serous Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ZN-c3

Experimental: ZN-c3 Single Agent - ZN-c3 (azenosertib) taken orally with food


Treatment: Drugs: ZN-c3
ZN-c3 is an investigational drug.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency and severity of TEAEs and incidence of dose modifications
Timepoint [1] 0 0
2 years
Primary outcome [2] 0 0
Objective Response Rate as defined by the revised RECIST v1.1 as assessed by ICR
Timepoint [2] 0 0
2 years
Secondary outcome [1] 0 0
Objective Response Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Duration of Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Progression Free Survival as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Clinical Benefit Rate as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Time To Response as defined by the revised RECIST v1.1. and assessed by ICR and the Investigator.
Timepoint [5] 0 0
2 years

Eligibility
Key inclusion criteria
INCLUSION CRITERIA

1. Females =18 years of age at the time of informed consent.
2. Histologically confirmed recurrent or persistent USC for which no other proven effective treatment options are available or any available standard of care therapy was not tolerated or was refused by the subject.

* Subjects with endometrial carcinoma of mixed histology where the serous component comprises at least 5% of the tumor will be considered eligible.
* Subjects with carcinosarcomas (even if there is a serous component) are not eligible.
3. Measurable disease per RECIST Guideline Version 1.1
4. Required prior therapy for endometrial cancer:

1. Treatment with a platinum-based chemotherapy regimen.
2. Treatment with a PD-(L)1 inhibitor
3. Known HER2-positive tumors: Treatment with at least 1 HER2-targeted therapy, except for subjects who are not clinically eligible.
5. Adequate hematologic and organ function

EXCLUSION CRITERIA

1. Any of the following treatment interventions within the specified time frame prior to C1D1:

1. Major surgery within 28 days
2. Any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter).
3. Radiation therapy within 21 days;
4. Autologous or allogeneic stem cell transplant within 3 months.
5. Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).
2. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, or CHK1/2 inhibitor for USC.
3. A serious illness or medical condition(s) including, but not limited to: Any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1D1.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Northern Cancer Institute - St Leonards
Recruitment hospital [2] 0 0
Icon Cancer Centre- Chermside - Brisbane
Recruitment hospital [3] 0 0
Mater Cancer Care Centre, Mater Misericordiae Limited - Brisbane
Recruitment hospital [4] 0 0
Burnside War Memorial Hospital - Toorak Gardens
Recruitment hospital [5] 0 0
Cabrini Hospital Malvern - Malvern
Recruitment hospital [6] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [7] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
4032 - Brisbane
Recruitment postcode(s) [3] 0 0
4101 - Brisbane
Recruitment postcode(s) [4] 0 0
6065 - Toorak Gardens
Recruitment postcode(s) [5] 0 0
3144 - Malvern
Recruitment postcode(s) [6] 0 0
3000 - Melbourne
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Georgia
State/province [23] 0 0
Kvemo Kartli
Country [24] 0 0
Georgia
State/province [24] 0 0
Republic Of Adjara
Country [25] 0 0
Georgia
State/province [25] 0 0
Tbilisi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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).
Trial website
https://clinicaltrials.gov/study/NCT04814108
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Project Director
Address 0 0
K-Group Beta (A wholly owned subsidiary of Zentalis Pharmaceuticals)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Project Director
Address 0 0
Country 0 0
Phone 0 0
(858) 263-4333
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04814108