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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
21/05/2025

Titles & IDs
Public title
A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant 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 (DENALI / ZN-c3-005 / GOG-3066)
Secondary ID [1] 0 0
ZN-c3-005
Universal Trial Number (UTN)
Trial acronym
DENALI
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 - azenosertib

Experimental: Part 1a/1b (Completed Enrollment) - Azenosertib 400mg administered on a 5 days on, 2 days off intermittent schedule.

Experimental: Part 2a: Arm 1 - Azenosertib 400mg administered on a 5 days on, 2 days off intermittent schedule

Experimental: Part 2a: Arm 2 - Azenosertib 300mg administered on a 5 days on, 2 days off intermittent schedule

Experimental: Part 2b - Azenosertib at the dose selected in Part 2a administered on a 5 days on, 2 days off intermittent schedule


Treatment: Drugs: azenosertib
Azenosertib (ZN-c3) will be administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) defined by RECIST v1.1 [Part 2]
Timepoint [1] 0 0
Up to approximately 12 months from the enrollment of the last subject
Secondary outcome [1] 0 0
Duration of response (DOR) defined by RECIST v1.1 [Part 2]
Timepoint [1] 0 0
Up to approximately 12 months from the enrollment of the last subject
Secondary outcome [2] 0 0
Progression free survival (PFS) defined by RECIST v1.1 [Part 2]
Timepoint [2] 0 0
Up to approximately 12 months from the enrollment of the last subject
Secondary outcome [3] 0 0
Clinical Benefit Rate (CBR) defined by RECIST v1.1 [Part 2]
Timepoint [3] 0 0
Up to approximately 12 months from the enrollment of the last subject
Secondary outcome [4] 0 0
CA-125 response by GCIG criteria [Part 2]
Timepoint [4] 0 0
Up to approximately 12 months from the enrollment of the last subject
Secondary outcome [5] 0 0
Number of Subjects experiencing treatment emergent adverse events (TEAEs) [Part 2]
Timepoint [5] 0 0
Up to approximately 12 months from the enrollment of the last subject

Eligibility
Key inclusion criteria
1. Age =18 years
2. High-grade serous ovarian, fallopian tube or primary peritoneal cancer
3. Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status result determined by IHC using the Sponsor's investigational clinical trial assay
4. Prior therapy:

1. Subjects must have platinum-resistant disease
2. One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
3. Prior bevacizumab treatment is required, if eligible per standard of care
4. Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if eligible per standard of care
5. Prior mirvetuximab treatment is required, if eligible per standard of care
5. Measurable disease per RECIST Version 1.1.
6. Adequate hematologic and organ function, as defined in protocol
7. ECOG 0-1
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Primary platinum-refractory disease
2. Any of the following treatment interventions within the specified time frame prior to C1D1:

1. Major surgery within 28 days
2. Hospitalization within 14 days
3. Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter);
4. Radiation therapy within 21 days;
5. Autologous or allogeneic stem cell transplant within 3 months.
6. Current use of any other investigational drug therapy <28 days or 5 half-lives (whichever is shorter).
7. Inability to discontinue treatment prescription or non-prescription drugs, or to discontinue consumption of food and herbal supplements that are strong or moderate CYP3A inhibitors and inducers or P-gp inhibitors at least 14 days prior to C1D1.
3. Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1 inhibitor, or CHK1/2 inhibitor.
4. A serious illness or medical condition(s) including, but not limited to:

1. Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.
2. Myocardial impairment resulting in heart failure (NYHA Class II-IV)
3. Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or may interfere with interpretation of study results
4. Acute kidney injury requiring intervention or intravenous fluid in the last 14 days or presence of indwelling urinary catheter or percutaneous nephrostomy.
5. Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for intravenous alimentation, active peptic ulcer, chronic diarrhea or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption.
6. Active, uncontrolled infection. Subjects with an infection receiving treatment (antibiotic, antifungal, or antiviral) must have completed such treatment and the infection must be considered controlled/resolved (and afebrile) by the Investigator for at least 7 days before C1D1
7. Any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (CT scan, recent hospitalization for small bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or thoracentesis within 6 weeks prior to C1D1.
5. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding Grade =2 neuropathy, alopecia, or skin pigmentation).
6. Pregnant or lactating female subject or female subject of childbearing potential who has a positive serum pregnancy test within 14 days prior to C1D1.
7. History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease free. Exceptions include appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, or other malignancies with an expected curative outcome.
8. Subjects who are known to be immunocompromised or HIV-positive on highly active anti-retroviral therapy.
9. Subjects with known active hepatitis B or hepatitis C infection.
10. Individuals who are judged by the Investigator to be unsuitable as study subjects.
11. Subjects who had prior wide-field radiotherapy affecting = 20% of the bone marrow.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
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
30/06/2027
Actual
Sample size
Target
170
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
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kentucky
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
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 York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Dakota
Country [22] 0 0
United States of America
State/province [22] 0 0
Texas
Country [23] 0 0
United States of America
State/province [23] 0 0
Virginia
Country [24] 0 0
France
State/province [24] 0 0
Alpes-Maritimes
Country [25] 0 0
France
State/province [25] 0 0
Nord
Country [26] 0 0
France
State/province [26] 0 0
Pays de la Loire
Country [27] 0 0
France
State/province [27] 0 0
Rhône
Country [28] 0 0
France
State/province [28] 0 0
Villejuif
Country [29] 0 0
Poland
State/province [29] 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
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05128825