🏛️ Verified NIH Record • Updated 2026-08-10
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)
🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (26 items).
Location: Site 0107 — Phoenix, Arizona
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (59 Sites)
- Site 0107 — Phoenix, Arizona
- Site 0110 — Antioch, California
- Site 0104 — Beverly Hills, California
- Site 0115 — San Francisco, California
- Site 0101 — Torrance, California
- Site 0111 — Camden, New Jersey
- Site 0108 — Columbus, Ohio
- Site 0105 — Portland, Oregon
- Site 0109 — Philadelphia, Pennsylvania
- Site 0113 — Philadelphia, Pennsylvania
- Site 0114 — Willow Grove, Pennsylvania
- Site 0112 — Sioux Falls, South Dakota
- Site 1101 — Randwick, New South Wales
- Site 1102 — Adelaide, South Australia
- Site 1103 — Nedlands,
- Site 3002 — Brussels,
- Site 3001 — Leuven,
- Site 0201 — Toronto, Ontario
- Site 0204 — Montreal, Quebec
- Site 0203 — Montreal, Quebec
- Site 0202 — Sherbrooke, Quebec
- Site 3508 — Besançon,
- Site 3502 — Brest,
- Site 3507 — Dijon,
- Site 3504 — Lyon,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.