A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression
ASPENOVA
A Randomized, Open-Label Phase 3 Study of Azenosertib Versus Investigator's Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression
3 other identifiers
interventional
420
12 countries
58
Brief Summary
This is a randomized, Phase 3 trial designed to evaluate the efficacy and safety of azenosertib compared to Investigator's choice of chemotherapy in subjects with platinum-resistant ovarian cancer whose tumors are positive for cyclin E1 protein expression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 ovarian-cancer
Started Apr 2026
58 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
March 26, 2026
CompletedStudy Start
First participant enrolled
April 17, 2026
CompletedFirst Posted
Study publicly available on registry
April 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2030
July 17, 2026
May 1, 2026
2.1 years
March 26, 2026
July 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS) per RECIST v1.1 as assessed by Investigator
Time from randomization to the first documented tumor progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Up to approximately 24 months from the enrollment of the last subject
Secondary Outcomes (7)
Overall survival
Up to approximately 24 months from the enrollment of the last subject
PFS per RECIST 1.1 as assessed by blinded independent central review (ICR)
Up to approximately 24 months from the enrollment of the last subject
Objective Response Rate (ORR) per RECIST v1.1 and assessed by Investigator
Up to approximately 24 months from the enrollment of the last subject
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire score (EORTC QLQ)-Core 30 (C30) at each post baseline visit
Up to approximately 24 months from the enrollment of the last subject
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire score (EORTC QLQ)-OV28 at each post baseline visit
Up to approximately 24 months from the enrollment of the last subject
- +2 more secondary outcomes
Study Arms (2)
Arm A Azenosertib 400 mg administered daily on a 5 days on, 2 days off intermittent schedule
EXPERIMENTALExperimental: Arm C Investigator's choice of chemotherapy at the dose defined by the protocol
ACTIVE COMPARATORInterventions
The investigator will select the chemotherapy in accordance with the protocol defined requirements. The possible choices as defined by the protocol: * Paclitaxel * Gemcitabine * Pegylated liposomal doxorubicin (PLD) * Topotecan The selected chemotherapy will be administered intravenously
Azenosertib 400 mg will be administered orally.
Eligibility Criteria
You may qualify if:
- Female age ≥ 18 years
- High-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Measurable disease per RECIST Version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score 0-1
- The subject's tumor tissue must be positive for cyclin E1 protein expression per the Sponsor's clinically validated cyclin E1 IHC investigational, in vitro diagnostic assay
- Prior Therapy:
- Subject must have platinum-resistant disease
- One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
- 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
- Adequate hematologic and organ function during the screening period
You may not qualify if:
- 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, nonmelanoma skin carcinoma, Stage 1 uterine cancer, or other malignancies with an expected curative outcome.
- Subjects with primary platinum-refractory disease.
- Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, or (PKMYT1) inhibitor for PROC.
- A serious illness or medical condition(s) including, but not limited to, the following:
- Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.
- Acute kidney injury requiring intervention, or presence of indwelling urinary catheter or percutaneous nephrostomy.
- Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for IV 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.
- Any evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for small bowel obstruction within 3 months before randomization, or recurrent paracentesis or thoracentesis within 6 weeks before randomization.
- 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 randomization
- Myocardial impairment of any cause resulting in heart failure by New York Heart Association criteria (Class II, III or IV).
- Medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
- Any of the following treatment interventions within the specified time frame before randomization:
- Hospitalization within 14 days
- Major surgery within 28 days
- Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter)
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Site 0107
Phoenix, Arizona, 85016, United States
Site 0110
Antioch, California, 94531, United States
Site 0115
San Francisco, California, 94109, United States
Site 0101
Torrance, California, 90505, United States
Site 0111
Camden, New Jersey, 08103, United States
Site 0108
Columbus, Ohio, 43026, United States
Site 0105
Portland, Oregon, 97210, United States
Site 0109
Philadelphia, Pennsylvania, 19104, United States
Site 0113
Philadelphia, Pennsylvania, 19111, United States
Site 0114
Willow Grove, Pennsylvania, 19090, United States
Site 0112
Sioux Falls, South Dakota, 57105, United States
Site 1101
Randwick, New South Wales, 2031, Australia
Site 1102
Adelaide, South Australia, 5000, Australia
Site 1103
Nedlands, 6009, Australia
Site 3002
Brussels, 1020, Belgium
Site 3001
Leuven, 3000, Belgium
Site 0201
Toronto, Ontario, M5G 2M9, Canada
Site 0204
Montreal, Quebec, H1T 2M4, Canada
Site 0203
Montreal, Quebec, H2X 0C1, Canada
Site 0202
Sherbrooke, Quebec, J1H 5N4, Canada
Site 3508
Besançon, 25000, France
Site 3502
Brest, 29609, France
Site 3507
Dijon, 21079, France
Site 3504
Lyon, 69373, France
Site 3503
Paris, 75014, France
Site 3501
Pierre-Bénite, 69495, France
Site 3509
Saint-Herblain, 44805, France
Site 3505
Strasbourg, 67098, France
Site 3506
Villejuif, 94805, France
Site 3602
Berlin, D-13353, Germany
Site 3601
Dresden, 01307, Germany
Site 3703
Cork, T12 DC4A, Ireland
Site 3702
Dublin, D08 NYH1, Ireland
Site 3801
Bologna, 40138, Italy
Site 3805
Milan, 20132, Italy
Site 3804
Milan, 20141, Italy
Site 3803
Milan, 20159, Italy
Site 3802
Naples, 80131, Italy
Site 3807
Prato, 59100, Italy
Site 3806
Rome, 00168, Italy
Site 4006
Krakow, 30-348, Poland
Site 4001
Lodz, 93-338, Poland
Site 4004
Poznan, 61-848, Poland
Site 4003
Szczecin, 70-111, Poland
Site 1203
Daegu, 42601, South Korea
Site 1206
Goyang-si, 10408, South Korea
Site 1202
Seoul, 03080, South Korea
Site 1205
Seoul, 03722, South Korea
Site 1204
Seoul, 06273, South Korea
Site 1201
Seoul, 06351, South Korea
Site 4201
Barcelona, 08028, Spain
Site 4205
Barcelona, 08041, Spain
Site 4202
Madrid, 28034, Spain
Site 4206
Madrid, 28040, Spain
Site 4203
Málaga, 29011, Spain
Site 4204
Vigo, 36212, Spain
Site 1301
Taichung, 40705, Taiwan
Site 1302
Taipei, 11217, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2026
First Posted
April 22, 2026
Study Start
April 17, 2026
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
April 30, 2030
Last Updated
July 17, 2026
Record last verified: 2026-05