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Compares treatment options for Ovarian Cancer
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?
Investigator's choice of Chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for 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
- 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.
- 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. Exceptions include appropriately...
- 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.
- 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. people with asymptomatic brain...
- Acute kidney injury requiring intervention, or presence of indwelling urinary catheter or percutaneous nephrostomy.
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
- 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
- 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...
- 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.
- 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. 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
- 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)
- 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's taking place
- Phoenix, Arizona, United States
- Antioch, California, United States
- San Francisco, California, United States
- Torrance, California, United States
- Camden, New Jersey, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Willow Grove, Pennsylvania, United States
- Sioux Falls, South Dakota, United States
- Randwick, New South Wales, Australia
- Adelaide, South Australia, Australia
- Nedlands, Australia
- Brussels, Belgium
- Leuven, Belgium
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Besançon, France
- Brest, France
+ 29 more site(s).
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 - 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?
Study sites include Phoenix, Arizona, United States; Antioch, California, United States; San Francisco, California, United States; Torrance, California, United States; Camden, New Jersey, United States; Columbus, Ohio, United States and 43 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.