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Clinical Trials in Ireland / NCT07546500
Recruiting Phase 3

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

NCT07546500 · tracked via the Priya Life Science Ireland tracker
Sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Phase
Phase 3
Started
2026-04-17
Last updated
2026-08-12

Condition(s) studied

Ovarian Cancer

Investigational drug(s) / intervention(s)

Investigator's choice of ChemotherapyAzenosertib

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

Azenosertib: Azenosertib 400 mg will be administered orally.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
Site 0107 Phoenix Arizona Not Yet Recruiting
Site 0110 Antioch California Not Yet Recruiting
Site 0104 Beverly Hills California Recruiting
Site 0115 San Francisco California Not Yet Recruiting
Site 0101 Torrance California Recruiting
Site 0111 Camden New Jersey Not Yet Recruiting
Site 0108 Columbus Ohio Not Yet Recruiting
Site 0105 Portland Oregon Not Yet Recruiting
Site 0109 Philadelphia Pennsylvania Not Yet Recruiting
Site 0113 Philadelphia Pennsylvania Not Yet Recruiting
Site 0114 Willow Grove Pennsylvania Not Yet Recruiting
Site 0112 Sioux Falls South Dakota Not Yet Recruiting
Site 1101 Randwick New South Wales Not Yet Recruiting
Site 1102 Adelaide South Australia Recruiting
Site 1103 Nedlands Australia Not Yet Recruiting
Site 3002 Brussels Belgium Not Yet Recruiting
Site 3001 Leuven Belgium Not Yet Recruiting
Site 0201 Toronto Ontario Not Yet Recruiting
Site 0204 Montreal Quebec Not Yet Recruiting
Site 0203 Montreal Quebec Not Yet Recruiting
Site 0202 Sherbrooke Quebec Not Yet Recruiting
Site 3508 Besançon France Not Yet Recruiting
Site 3502 Brest France Not Yet Recruiting
Site 3507 Dijon France Not Yet Recruiting
Site 3504 Lyon France Not Yet Recruiting
Site 3503 Paris France Not Yet Recruiting
Site 3501 Pierre-Bénite France Not Yet Recruiting
Site 3509 Saint-Herblain France Not Yet Recruiting
Site 3505 Strasbourg France Not Yet Recruiting
Site 3506 Villejuif France Not Yet Recruiting
Site 3602 Berlin Germany Not Yet Recruiting
Site 3601 Dresden Germany Not Yet Recruiting
Site 3703 Cork Ireland Not Yet Recruiting
Site 3702 Dublin Ireland Not Yet Recruiting
Site 3801 Bologna Italy Not Yet Recruiting
Site 3805 Milan Italy Not Yet Recruiting
Site 3804 Milan Italy Not Yet Recruiting
Site 3803 Milan Italy Not Yet Recruiting
Site 3802 Naples Italy Not Yet Recruiting
Site 3807 Prato Italy Not Yet Recruiting

+ 19 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07546500 on ClinicalTrials.gov ↗ ← All trials in Ireland