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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05128825




Registration number
NCT05128825
Ethics application status
Date submitted
28/10/2021
Date registered
22/11/2021
Date last updated
18/06/2024

Titles & IDs
Public title
A Study of ZN-c3 in Subjects With High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Scientific title
A Phase 2 Open-Label, Multicenter Study To Evaluate Efficacy And Safety Of ZN-c3 In Subjects With High-Grade Serous Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer (ZN-c3-005/GOG-3066/DENALI)
Secondary ID [1] 0 0
ZN-c3-005
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach

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

Other: Open-label with ZN-c3 (also known as azenosertib) - 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 of TEAEs
Timepoint [1] 0 0
Cycle 1 Day 1 until 30 days after treatment discontinuation
Primary outcome [2] 0 0
Severity of TEAEs
Timepoint [2] 0 0
Cycle 1 Day 1 until 30 days after treatment discontinuation
Primary outcome [3] 0 0
Incidence of dose modifications
Timepoint [3] 0 0
Cycle 1 Day 1 until 30 days after treatment discontinuation
Primary outcome [4] 0 0
Overall Response Rate defined by the revised RECIST v1 .1. and assessed by ICR.
Timepoint [4] 0 0
Every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months
Secondary outcome [1] 0 0
Overall Response Rate as defined by the revised RECIST v1 .1. and assessed by ICR and the Investigator.
Timepoint [1] 0 0
Every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months
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
Every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 60 months
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
Every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months
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
Every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months
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
Every 6 weeks until disease progression or date of death from any cause, whichever came first, assessed up to approximately 12 months

Eligibility
Key inclusion criteria
1. Age =18 years
2. High-grade serous ovarian cancer
3. Prior therapy:

1. Subjects must have platinum-resistant disease
2. One to 4 prior lines or regimens are allowed (1 to 5 prior lines are permitted in part 1b)
3. Prior bevacizumab treatment is required
4. Measurable disease per RECIST Version 1.1.
5. Adequate hematologic and organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.
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 C1 D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1 D1.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
Site 2715 - Icon Cancer Centre - Chermside - Brisbane
Recruitment hospital [2] 0 0
Site 2707 - Mater Brisbane - South Brisbane
Recruitment hospital [3] 0 0
Site 2709 - Icon Cancer Research Adelaide - Adelaide
Recruitment hospital [4] 0 0
Site 2702 - Burnside War Memorial Hospital - The Brian Fricker Oncology Centre - Toorak Gardens
Recruitment hospital [5] 0 0
Site 2701 - Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [6] 0 0
Site 2717 - St John of God Hospital Subiaco - Subiaco
Recruitment postcode(s) [1] 0 0
4032 - Brisbane
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
5037 - Adelaide
Recruitment postcode(s) [4] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
Nevada
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Dakota
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Utah
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Wisconsin
Country [27] 0 0
France
State/province [27] 0 0
Alpes-Maritimes
Country [28] 0 0
France
State/province [28] 0 0
Nord
Country [29] 0 0
France
State/province [29] 0 0
Pays De La Loire
Country [30] 0 0
France
State/province [30] 0 0
Rhône
Country [31] 0 0
France
State/province [31] 0 0
Villejuif
Country [32] 0 0
Poland
State/province [32] 0 0
Malopolskie

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
A Phase 2 study to evaluate the clinical activity, safety, and potentially predictive biomarker profile of ZN-c3 in subjects with High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Trial website
https://clinicaltrials.gov/study/NCT05128825
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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
medicalaffairs@zentalis.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05128825