A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
DENALI
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)
1 other identifier
interventional
310
8 countries
91
Brief Summary
This is a multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose tumors are Cyclin E1 positive as determined by central review using the Sponsor's investigational clinical trial assay.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2022
Longer than P75 for phase_2
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2021
CompletedFirst Posted
Study publicly available on registry
November 22, 2021
CompletedStudy Start
First participant enrolled
February 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
May 1, 2026
December 1, 2025
4.8 years
October 28, 2021
April 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR) defined by RECIST v1.1 [Part 2]
Participants who achieve partial response (PR) or complete response (CR) per RECIST v1.1 criteria.
Up to approximately 12 months from the enrollment of the last subject
Secondary Outcomes (5)
Duration of response (DOR) defined by RECIST v1.1 [Part 2]
Up to approximately 12 months from the enrollment of the last subject
Progression free survival (PFS) defined by RECIST v1.1 [Part 2]
Up to approximately 12 months from the enrollment of the last subject
Clinical Benefit Rate (CBR) defined by RECIST v1.1 [Part 2]
Up to approximately 12 months from the enrollment of the last subject
CA-125 response by GCIG criteria [Part 2]
Up to approximately 12 months from the enrollment of the last subject
Number of Subjects experiencing treatment emergent adverse events (TEAEs) [Part 2]
Up to approximately 12 months from the enrollment of the last subject
Study Arms (5)
Part 1a/1b (Completed Enrollment)
EXPERIMENTALAzenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule.
Part 2a: Arm 1 (Completed Enrollment)
EXPERIMENTALAzenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule
Part 2a: Arm 2 (Completed Enrollment)
EXPERIMENTALAzenosertib 300mg administered once daily on a 5 days on, 2 days off intermittent schedule
Part 2b
EXPERIMENTALAzenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule
Part 2c
EXPERIMENTALAzenosertib 400mg administered once daily on a 5 days on, 2 days off intermittent schedule
Interventions
Azenosertib (ZN-c3) will be administered orally.
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- High-grade serous ovarian, fallopian tube or primary peritoneal cancer
- Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status result determined by IHC using the Sponsor's investigational clinical trial assay
- Prior therapy:
- Subjects must have platinum-resistant disease
- Parts 2a and 2b: One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
- Part 2c: Subjects with PROC may have 1 to 4 prior lines or regimens. Prior treatment in this cohort includes a weekly taxane regimen, either as single agent or in combination, per protocol
- Prior bevacizumab treatment is required, if eligible per standard of care
- Prior PARP inhibitor treatment is required if BRCA 1/2 mutation or HRD, if eligible per standard of care
- Prior mirvetuximab treatment is required, if eligible per standard of care
- Measurable disease per RECIST Version 1.1.
- Adequate hematologic and organ function, as defined in protocol
- ECOG 0-1
You may not qualify if:
- Primary platinum-refractory disease
- Subjects with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, low-grade, borderline, or other ovarian tumors
- Any of the following treatment interventions within the specified time frame prior to C1D1:
- Major surgery within 28 days
- Hospitalization within 14 days
- Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter);
- Radiation therapy within 21 days;
- Autologous or allogeneic stem cell transplant within 3 months.
- Current use of any other investigational drug therapy \<28 days or 5 half-lives (whichever is shorter).
- 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.
- Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1 inhibitor, or CHK1/2 inhibitor.
- A serious illness or medical condition(s) including, but not limited to:
- Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.
- Myocardial impairment resulting in heart failure (NYHA Class II-IV)
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (91)
Site 0170-USA Mitchell Cancer Institute
Mobile, Alabama, 36604, United States
Site 0143 - HonorHealth
Phoenix, Arizona, 85016, United States
Site 0102 - University of Arizona Cancer Center
Tucson, Arizona, 85724, United States
Site 0258 - UC San Diego Moores Cancer Center
La Jolla, California, 92037, United States
Site 0287 - Ridley Tree Cancer Center
Santa Barbara, California, 93105, United States
Site 0135 - Rocky Mountain Cancer Centers
Lone Tree, Colorado, 80218, United States
Site 0158 - Hartford HealthCare
Hartford, Connecticut, 06106, United States
Site 0239 - Florida Cancer Specialists - East
Daytona Beach, Florida, 32117, United States
Site 0173 - Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Site 0308 - Advent Health
Orlando, Florida, 32803, United States
Site 0108 - Emory University Hospital
Atlanta, Georgia, 30322, United States
Site 0236 - Memorial Health
Savannah, Georgia, 31404, United States
Site 0324 - Illinois Cancer Specialists
Niles, Illinois, 60714, United States
Site 0284 - Community Cancer Center North
Indianapolis, Indiana, 46250, United States
Site 0217 - St Vincent Hospital and Health Care Centers
Indianapolis, Indiana, 46260, United States
Site 0251 - Norton Cancer Institute
Louisville, Kentucky, 40202, United States
Site 0146 - Maryland Oncology Hematology, PA
Rockville, Maryland, 20876, United States
Site 0221 - Tufts Medical Center - PPDS
Boston, Massachusetts, 02111, United States
Site 0104 - Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Site 0307 - Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Site 0263 - Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Site 0101 - Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Site 0228 - Corewell Health Medical Group West
Grand Rapids, Michigan, 49503, United States
Site 0288 - Minnesota Oncology Hematology - Maplewood
Maplewood, Minnesota, 55109, United States
Site 0226 - CoxHealth
Springfield, Missouri, 65807, United States
Site 0317 - Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Site 0213 - Center of Hope
Reno, Nevada, 89511, United States
Site 0231 - Northwell Health Cancer Institute
Manhasset, New York, 11030, United States
Site 0126 - Wilmot Cancer Center
Rochester, New York, 14642, United States
Site 0259 - Duke Cancer Center
Durham, North Carolina, 27710, United States
Site 0147 - Trihealth Cancer Institute - Harold and Eugen
Cincinnati, Ohio, 45242, United States
Site 0243 - Mark H Zangmeister Cancer Center
Columbus, Ohio, 43219, United States
Site 0214-Ohio State University Comprehensive Cancer Center
Hilliard, Ohio, 43026, United States
Site 0316 - Willamette Valley Cancer Institute/Oncology Associates of Oregon
Eugene, Oregon, 97401, United States
Site 0232 - University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Site 0178 - Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Site 0277 - Alliance Cancer Specialist, PC
Wynnewood, Pennsylvania, 19096, United States
Site 0132 - Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Site 0103 - University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Site 0234 - University of Texas Health, Memorial Hermann Hospital
Houston, Texas, 77030, United States
Site 0203 - Texas Oncology
Tyler, Texas, 75702, United States
Site 0295 - Virginia Oncology Associates
Chesapeake, Virginia, 23320, United States
Site 0322 - Inova Schar Cancer Institute
Fairfax, Virginia, 22031, United States
Site 0323 - Compass Oncology
Vancouver, Washington, 98684, United States
Site 2715 - Icon Cancer Centre - Chermside
Chermside, Queensland, 4032, Australia
Site 2707 - Mater Brisbane
South Brisbane, Queensland, 4101, Australia
Site 2709 - Cancer Research SA
Adelaide, South Australia, 5037, Australia
Site 2702 - Burnside War Memorial Hospital - The Brian Fricker Oncology Centre
Toorak Gardens, South Australia, 5065, Australia
Site 2716 - Epworth Healthcare Freemasons
East Melbourne, Victoria, 3002, Australia
Site 2701 - Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
Site 2717 - St John of God Hospital Subiaco
Subiaco, Western Australia, 6008, Australia
Site 3102 - Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, 1200, Belgium
Site 3101 - AZORG - Aalst
Aalst, Oost-Vlaanderen, 9300, Belgium
Site 3105 - UZ Leuven
Leuven, Vlaams Brabant, 3000, Belgium
Site 3616 - Centre Antoine Lacassagne
Nice, Alpes-Maritimes, 06100, France
Site 3611 - ICANS - Institut de cancérologie Strasbourg Europe
Strasbourg, Bas-Rhin, 67200, France
Site 3601 - Centre Georges François Leclerc
Dijon, Côte-d'Or, 21079, France
Site 3613 - CHRU Besancon - Hopital Jean Minjoz
Besançon, Doubs, 25030, France
Site 3617 - CHU de Brest - Hôpital La Cavale Blanche
Brest, Finistere, 29200, France
Site 3603 - Institut Claudius Regaud
Toulouse, Haute-Garonne, 31000, France
Site 3602 - Centre Oscar Lambret
Lille, Nord, 59000, France
Site 3615 - Hôpital Cochin Port-Royal AP-HP
Paris, Paris, 75181, France
Site 3614 - Institut de Cancerologie de l'oust
Saint-Herblain, Pays de la Loire Region, 44800, France
Site 3608 - Hospices Civils de Lyon - Hôpital Lyon Sud
Pierre-Bénite, Rhône, 69310, France
Site 3619 - Centre Léon Bérard
Lyon, 69373, France
Site 3620 - CHU de Strasbourg - Hopital de Hautepierre
Strasbourg, 67200, France
Site 3604 - Institut Gustave Roussy
Villejuif, 94800, France
Site 3302 - Istituto Nazionale Tumori IRCCS Fondazione Giovanni Pascale
Naples, Campania, 80131, Italy
Site 3308 - Azienda Ospedaliero Universitaria Di Modena Policlinico
Modena, Emilia-Romagna, 41124, Italy
Site 3312 - Centro di Riferimento Oncologico
Aviano, Friuli Venezia Giulia, 33081, Italy
Site 3304 - Fondazione Policlinico Universitario A Gemelli
Rome, Lazio, 168, Italy
Site 3305 - Istituto Europeo di Oncologia
Milan, Lombardy, 20141, Italy
Site 3307 - Ospedale San Raffaele S.r.l.
Milan, Milano, 20132, Italy
Site 3311 - Azienda Ospedaliera Universitaria Integrata Di Verona
Verona, Veneto, 37126, Italy
Site 3303 - Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi-Via Massarenti
Bologna, 40138, Italy
Site 2414 - Med-Polonia Sp. z o.o.
Poznan, Greater Poland Voivodeship, 60-693, Poland
Site 2405 - Centrum Badan Klinicznych JCI
Krakow, Lesser Poland Voivodeship, 30-348, Poland
Site 2404 - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
Warsaw, Masovian Voivodeship, 02-781, Poland
Site 2419 - Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie w Bialymstoku
Bialystok, Podlaskie Voivodeship, 15-027, Poland
Site 2421 - Szpitale Pomorskie Sp. z o. o.
Gdynia, Pomeranian Voivodeship, 81-519, Poland
Site 2908 - National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Site 2905 - Seoul National University Hospital
Seoul, 03080, South Korea
Site 2909 - Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Site 2904 - Asan Medical Center
Seoul, 05505, South Korea
Site 2906 - Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273, South Korea
Site 2907 - Samsung Medical Center
Seoul, 06351, South Korea
Site 3511 - Instituto de Investigacion Oncologica Vall d'Hebron
Barcelona, Barcelona, 8035, Spain
Site 3517 - Clinica Universidad de Navarra
Madrid, Madrid, 28027, Spain
Site 3516 - Hospital Universitario Virgen de La Arrixaca
Murcia, Murcia, 30120, Spain
Site 3501 - Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010, Spain
Site 3502 - Hospital Universitario La Paz
Madrid, 28046, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2021
First Posted
November 22, 2021
Study Start
February 17, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
May 1, 2026
Record last verified: 2025-12