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)

November 6, 2026 updated by: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A Phase 3 study to evaluate the efficacy, safety, and overall clinical benefit of azenosertib (ZN-c3) compared with Investigator's choice of chemotherapy in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Azenosertib is a selective and orally bioavailable inhibitor of WEE1. In HGSOC, high Cyclin E1 protein drives replication stress and increases tumor reliance on WEE1-mediated G2/M checkpoint control. Treating tumor cells with azenosertib promotes premature cell cycle progression leading to increased replication stress and accumulation of DNA damage pushing cells to mitotic catastrophe resulting in tumor cell death.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
420

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ANZ
        • Not yet recruiting
        • Site 2105
      • Córdoba, Argentina, X5000AAW
        • Not yet recruiting
        • Site 2101
      • Córdoba, Argentina, X5008AAC
        • Not yet recruiting
        • Site 2102
      • Rosario, Argentina, S2002
        • Not yet recruiting
        • Site 2104
      • San Miguel de Tucumán, Argentina, T4000GTB
        • Not yet recruiting
        • Site 2103
  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Recruiting
        • Site 1101
      • Westmead, New South Wales, Australia, 2145
        • Not yet recruiting
        • Site 1105
      • Wollongong, New South Wales, Australia, 2500
        • Not yet recruiting
        • Site 1108
    • Queensland
      • South Brisbane, Queensland, Australia, 4101
        • Not yet recruiting
        • Site 1107
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Site 1102
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Not yet recruiting
        • Site 1103
      • Subiaco, Western Australia, Australia, 6008
        • Not yet recruiting
        • Site 1104
  • Belgium
      • Brussels, Belgium, 1020
        • Recruiting
        • Site 3002
      • Edegem, Belgium, 2650
        • Not yet recruiting
        • Site 3003
      • Leuven, Belgium, 3000
        • Not yet recruiting
        • Site 3001
  • Brazil
      • Belo Horizonte, Brazil, 30.360-680
        • Not yet recruiting
        • Site 2209
      • Curitiba, Brazil, 80810-050
        • Not yet recruiting
        • Site 2208
      • Goiânia, Brazil, 74605-070
        • Not yet recruiting
        • Site 2207
      • Porto Alegre, Brazil, 90110-270
        • Not yet recruiting
        • Site 2201
      • Porto Alegre, Brazil, 90470-340
        • Not yet recruiting
        • Site 2203
      • Rio de Janeiro, Brazil, 22281-100
        • Not yet recruiting
        • Site 2205
      • Rio de Janeiro, Brazil, 22775-001
        • Not yet recruiting
        • Site 2206
      • São José do Rio Preto, Brazil, 15090-000
        • Not yet recruiting
        • Site 2202
      • São Paulo, Brazil, 01401-002
        • Not yet recruiting
        • Site 2204
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L3
        • Not yet recruiting
        • Site 0207
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Not yet recruiting
        • Site 0205
      • Toronto, Ontario, Canada, M5G 2M9
        • Not yet recruiting
        • Site 0201
    • Quebec
      • Montreal, Quebec, Canada, H2X 0C1
        • Not yet recruiting
        • Site 0203
      • Montreal, Quebec, Canada, H4A 3J1
        • Not yet recruiting
        • Site 0206
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Not yet recruiting
        • Site 0202
  • Croatia
      • Rijeka, Croatia, 51000
        • Not yet recruiting
        • Site 3103
      • Zagreb, Croatia, 10000
        • Not yet recruiting
        • Site 3101
      • Zagreb, Croatia, 10000
        • Not yet recruiting
        • Site 3102
  • Denmark
      • Aalborg, Denmark, 9000
        • Not yet recruiting
        • Site 3203
      • Copenhagen, Denmark, 2100
        • Not yet recruiting
        • Site 3201
      • Roskilde, Denmark, 4000
        • Not yet recruiting
        • Site 3202
  • Estonia
      • Tallinn, Estonia, 13419
        • Not yet recruiting
        • Site 3302
      • Tartu, Estonia, 50406
        • Not yet recruiting
        • Site 3301
  • Finland
      • Kuopio, Finland, 70210
        • Not yet recruiting
        • Site 3403
      • Oulu, Finland, 90220
        • Not yet recruiting
        • Site 3401
      • Tampere, Finland, 33520
        • Not yet recruiting
        • Site 3402
  • France
      • Besançon, France, 25000
        • Not yet recruiting
        • Site 3508
      • Brest, France, 29609
        • Not yet recruiting
        • Site 3502
      • Dijon, France, 21079
        • Not yet recruiting
        • Site 3507
      • Lyon, France, 69373
        • Not yet recruiting
        • Site 3504
      • Marseille, France, 13273
        • Not yet recruiting
        • Site 3510
      • Paris, France, 75014
        • Not yet recruiting
        • Site 3503
      • Pierre-Bénite, France, 69495
        • Not yet recruiting
        • Site 3501
      • Saint-Herblain, France, 44805
        • Not yet recruiting
        • Site 3509
      • Strasbourg, France, 67098
        • Not yet recruiting
        • Site 3505
      • Villejuif, France, 94805
        • Recruiting
        • Site 3506
  • Germany
      • Berlin, Germany, D-13353
        • Not yet recruiting
        • Site 3602
      • Bonn, Germany, 53127
        • Not yet recruiting
        • Site 3603
      • Dresden, Germany, 01307
        • Not yet recruiting
        • Site 3601
      • Düsseldorf, Germany, 40225
        • Not yet recruiting
        • Site 3605
      • Tübingen, Germany, 72076
        • Not yet recruiting
        • Site 3604
  • Ireland
      • Cork, Ireland, T12 DC4A
        • Not yet recruiting
        • Site 3703
      • Dublin, Ireland, D08 NYH1
        • Not yet recruiting
        • Site 3702
      • Dublin, Ireland, D07 R2WY
        • Not yet recruiting
        • Site 3704
  • Israel
      • Ashdod, Israel, 7747629
        • Not yet recruiting
        • Site 5009
      • Haifa, Israel, 3109601
        • Not yet recruiting
        • Site 5002
      • Holon, Israel, 5822012
        • Not yet recruiting
        • Site 5007
      • Jerusalem, Israel, 9103102
        • Not yet recruiting
        • Site 5001
      • Nahariya, Israel, 2210001
        • Not yet recruiting
        • Site 5006
      • Petah Tikva, Israel, 49100
        • Not yet recruiting
        • Site 5003
      • Safed, Israel, 1311001
        • Not yet recruiting
        • Site 5008
      • Tel Aviv, Israel, 6423906
        • Not yet recruiting
        • Site 5004
      • Tel HaShomer, Israel, 5265601
        • Not yet recruiting
        • Site 5005
  • Italy
      • Bologna, Italy, 40138
        • Not yet recruiting
        • Site 3801
      • Florence, Italy, 50134
        • Not yet recruiting
        • Site 3814
      • Milan, Italy, 20132
        • Not yet recruiting
        • Site 3805
      • Milan, Italy, 20141
        • Not yet recruiting
        • Site 3804
      • Milan, Italy, 20159
        • Not yet recruiting
        • Site 3803
      • Milan, Italy, 20121
        • Not yet recruiting
        • Site 3812
      • Milan, Italy, 20133
        • Not yet recruiting
        • Site 3813
      • Naples, Italy, 80131
        • Not yet recruiting
        • Site 3802
      • Pisa, Italy, 56126
        • Not yet recruiting
        • Site 3808
      • Prato, Italy, 59100
        • Not yet recruiting
        • Site 3807
      • Roma, Italy, 00185
        • Not yet recruiting
        • Site 3810
      • Rome, Italy, 00168
        • Not yet recruiting
        • Site 3806
      • Torino, Italy, 10128
        • Not yet recruiting
        • Site 3811
      • Vicenza, Italy, 36100
        • Not yet recruiting
        • Site 3809
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Not yet recruiting
        • Site 3901
      • Groningen, Netherlands, 9700 RB
        • Not yet recruiting
        • Site 3902
      • Nijmegen, Netherlands, 6525 GA
        • Not yet recruiting
        • Site 3903
  • Poland
      • Gdansk, Poland, 80-214
        • Not yet recruiting
        • Site 4005
      • Krakow, Poland, 30-348
        • Not yet recruiting
        • Site 4006
      • Krakow, Poland, 31-531
        • Not yet recruiting
        • Site 4008
      • Poznan, Poland, 61-848
        • Not yet recruiting
        • Site 4004
      • Poznan, Poland, 61-866
        • Not yet recruiting
        • Site 4002
      • Siedlce, Poland, 08-110
        • Not yet recruiting
        • Site 4007
      • Szczecin, Poland, 70-111
        • Not yet recruiting
        • Site 4003
  • Portugal
      • Coimbrã, Portugal, 3000-075
        • Not yet recruiting
        • Site 4106
      • Lisbon, Portugal, 1099-023
        • Not yet recruiting
        • Site 4104
      • Lisbon, Portugal, 1400-038
        • Not yet recruiting
        • Site 4103
      • Lisbon, Portugal, 1500-650
        • Not yet recruiting
        • Site 4102
      • Lisbon, Portugal, 1649-035
        • Not yet recruiting
        • Site 4105
      • Porto, Portugal, 4200-072
        • Not yet recruiting
        • Site 4101
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Recruiting
        • Site 0137
  • South Korea
      • Daegu, South Korea, 42601
        • Recruiting
        • Site 1203
      • Goyang-si, South Korea, 10408
        • Recruiting
        • Site 1206
      • Seoul, South Korea, 03722
        • Recruiting
        • Site 1205
      • Seoul, South Korea, 03080
        • Recruiting
        • Site 1202
      • Seoul, South Korea, 06351
        • Recruiting
        • Site 1201
      • Seoul, South Korea, 06273
        • Recruiting
        • Site 1204
  • Spain
      • Barcelona, Spain, 08028
        • Not yet recruiting
        • Site 4201
      • Barcelona, Spain, 08041
        • Not yet recruiting
        • Site 4205
      • Madrid, Spain, 28040
        • Not yet recruiting
        • Site 4206
      • Madrid, Spain, 28034
        • Recruiting
        • Site 4202
      • Málaga, Spain, 29011
        • Not yet recruiting
        • Site 4203
      • Vigo, Spain, 36212
        • Recruiting
        • Site 4204
  • Taiwan
      • Taichung, Taiwan, 40705
        • Not yet recruiting
        • Site 1301
      • Taipei, Taiwan, 11217
        • Not yet recruiting
        • Site 1302
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Not yet recruiting
        • Site 0107
    • California
      • Antioch, California, United States, 94531
        • Not yet recruiting
        • Site 0110
      • Beverly Hills, California, United States, 90212
        • Recruiting
        • Site 0104
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Site 0122
      • San Francisco, California, United States, 94109
        • Not yet recruiting
        • Site 0115
      • Torrance, California, United States, 90505
        • Recruiting
        • Site 0101
    • Florida
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Site 0116
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Site 0123
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Not yet recruiting
        • Site 0111
    • Ohio
      • Columbus, Ohio, United States, 43026
        • Not yet recruiting
        • Site 0108
    • Oregon
      • Portland, Oregon, United States, 97210
        • Not yet recruiting
        • Site 0105
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Not yet recruiting
        • Site 0113
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Site 0109
      • Willow Grove, Pennsylvania, United States, 19090
        • Not yet recruiting
        • Site 0114
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Not yet recruiting
        • Site 0112
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Site 0117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female age ≥ 18 years

  2. High-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer

  3. Measurable disease per RECIST Version 1.1

  4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1

  5. 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

  6. Prior Therapy:

    1. Subject 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

  7. Adequate hematologic and organ function during the screening period

Exclusion Criteria:

  1. 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.

  2. Subjects with primary platinum-refractory disease.

  3. Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, or (PKMYT1) inhibitor for PROC.

  4. A serious illness or medical condition(s) including, but not limited to, the following:

    1. Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. Subjects with asymptomatic brain metastases are eligible.
    2. Acute kidney injury requiring intervention, or presence of indwelling urinary catheter or percutaneous nephrostomy.
    3. 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.
    4. 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.
    5. 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
    6. Myocardial impairment of any cause resulting in heart failure by New York Heart Association criteria (Class II, III or IV).
    7. 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

  5. Any of the following treatment interventions within the specified time frame before randomization:

    1. Hospitalization within 14 days
    2. Major surgery within 28 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)

  6. Inability to discontinue treatment with prescription or nonprescription drugs that are prohibited per protocol.

  7. Inability to discontinue consumption of food and herbal supplements that are prohibited per protocol

  8. Prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.

  9. Unresolved toxicity of Grade > 1 attributed to any prior therapies (excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation).

  10. Subjects who are immunocompromised or HIV-positive on highly active anti-retroviral therapy

  11. Subjects with known active hepatitis B or hepatitis C infection

  12. Individuals who are judged by the Investigator to be unsuitable as study subjects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Experimental: Arm C Investigator's choice of chemotherapy at the dose defined by the protocol
Drug: Investigator's choice of Chemotherapy

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
Experimental: Arm A Azenosertib 400 mg administered daily on a 5 days on, 2 days off intermittent schedule
Drug: Azenosertib

Azenosertib 400 mg will be administered orally.

Other Names:
  • ZN-c3

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS) per RECIST v1.1 as assessed by Investigator
Time Frame: Up to approximately 24 months from the enrollment of the last subject

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to approximately 24 months from the enrollment of the last subject

Time from randomization until death due to any cause
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)
Time Frame: Up to approximately 24 months from the enrollment of the last subject

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
Objective Response Rate (ORR) per RECIST v1.1 and assessed by Investigator
Time Frame: Up to approximately 24 months from the enrollment of the last subject

Proportion of patients who attain a partial response (PR) or complete response (CR) per RECIST v1.1
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
Time Frame: Up to approximately 24 months from the enrollment of the last subject

Assess changes over time in cancer-specific and patient-reported outcome instruments assessing global health status/quality of life, functional domains, and symptom burden.
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
Time Frame: Up to approximately 24 months from the enrollment of the last subject

Assess changes over time in cancer-specific and patient-reported outcome instruments assessing global health status/quality of life, functional domains, and symptom burden.
Up to approximately 24 months from the enrollment of the last subject
Change from baseline in EQ-5D-5L score at each post baseline visit
Time Frame: Up to approximately 24 months from the enrollment of the last subject

Assess changes over time in cancer-specific and patient-reported outcome instruments assessing global health status/quality of life, functional domains, and symptom burden.
Up to approximately 24 months from the enrollment of the last subject
Number of Subjects experiencing treatment emergent adverse events (TEAEs)
Time Frame: Up to approximately 24 months and 30 days from the enrollment of the last subject

Assess adverse events occurring for the first time or worsening of a pre-existing event during the treatment period until 30 days after the last dose of study drug
Up to approximately 24 months and 30 days from the enrollment of the last subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZN-c3-020
  • GOG-3147 (Other Identifier: GOG Foundation, Inc.)
  • ENGOT-ov109 (Other Identifier: ENGOT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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