Ovarian Cancer study: Azenosertib
Official title 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
ClinicalTrials.gov ID: NCT07546500
What this study is testing
What is Investigator's choice of Chemotherapy?
An investigational chemotherapy being studied for platinum‑resistant ovarian cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study compares how well azenosertib works and how safe it is versus the chemotherapy the doctor picks for patients whose ovarian cancer does not respond to platinum drugs and whose tumors have cyclin E1 protein.
- Who it's for
- Adults with platinum‑resistant ovarian, primary peritoneal, or fallopian tube cancer whose tumors test positive for cyclin E1 protein.
- What's involved
- Participants will receive either azenosertib or the chemotherapy chosen by their investigator, with regular visits for treatment, monitoring, and safety tests.
- Time commitment
- The trial lasts several months, with scheduled visits for treatment and follow‑up assessments as directed by the study protocol.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
You likely can't join if
- History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease-free.
- people with primary platinum-refractory disease.
- Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, or (PKMYT1) inhibitor for PROC.
- Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment.
- 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...
See the full eligibility criteria
- 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
- 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
- History of another malignancy in the previous 2 years, unless cured by surgery alone and continuously disease-free.
- people with primary platinum-refractory disease.
- Prior therapy with azenosertib or any other WEE1 inhibitor, ATR inhibitor, CHK1/2 inhibitor, or (PKMYT1) inhibitor for PROC.
- Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. people 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...
- 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...
- Active, uncontrolled infection. people with an infection receiving treatment (antibiotic, antifungal, or antiviral) must have completed such treatment and the infection must be considered controlled/resolved (and...
- 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
- 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)
- 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 with prescription or nonprescription drugs that are prohibited per protocol.
- Inability to discontinue consumption of food and herbal supplements that are prohibited per protocol
- Prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.
- Unresolved toxicity of Grade \> 1 attributed to any prior therapies (excluding Grade ≤ 2 neuropathy, alopecia, or skin pigmentation).
- people who are immunocompromised or HIV-positive on highly active anti-retroviral therapy
- people with known active hepatitis B or hepatitis C infection
- Individuals who are judged by the Investigator to be unsuitable as study people
The study team makes the final eligibility decision.
Where it is enrolling
- Beverly Hills, California, United States
- Fountain Valley, California, United States
- Torrance, California, United States
- Orlando, Florida, United States
- Baltimore, Maryland, United States
- Philadelphia, Pennsylvania, United States
- Fort Worth, Texas, United States
- Randwick, New South Wales, Australia
- Adelaide, South Australia, Australia
- Brussels, Belgium
- Villejuif, France
- San Juan, Puerto Rico
- Daegu, South Korea
- Goyang-si, South Korea
- Seoul, South Korea
- Madrid, Spain
- Vigo, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Beverly Hills, California, United States; Fountain Valley, California, United States; Torrance, California, United States; Orlando, Florida, United States; Baltimore, Maryland, United States; Philadelphia, Pennsylvania, United States and 11 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.