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New treatment option for High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Official title A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
ClinicalTrials.gov ID: NCT05128825
What this study is testing
What is azenosertib?
azenosertib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for high-grade serous ovarian, fallopian tube or primary peritoneal cancer.
Also referred to as ZN-c3.
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 multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose tumors are Cyclin E1 positive as determined by central review using the Sponsor's investigational clinical trial assay.
- Phase 2: a mid-size study of how well it works
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
- Age ≥18 years
- High-grade serous ovarian, fallopian tube or primary peritoneal cancer
- Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status result determined by IHC using the Sponsor's investigational...
- Prior therapy:
- people must have platinum-resistant disease
You likely can't join if
- Primary platinum-refractory disease
- people with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, low-grade...
- Any of the following treatment interventions within the specified time frame prior to C1D1:
- Major surgery within 28 days
- Hospitalization within 14 days
- Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter);
See the full eligibility criteria
- Age ≥18 years
- High-grade serous ovarian, fallopian tube or primary peritoneal cancer
- Tumor testing (archival acceptable) confirms a positive Cyclin E1 protein status result determined by IHC using the Sponsor's investigational clinical trial assay
- Prior therapy:
- people must have platinum-resistant disease
- Parts 2a and 2b: One to 3 prior lines or regimens are allowed (1 to 4 prior lines are permitted, if prior mirvetuximab)
- Part 2c: people with PROC may have 1 to 4 prior lines or regimens. Prior treatment in this cohort includes a weekly taxane regimen, either as single agent or in combination, per protocol
- 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
- Measurable disease per RECIST Version 1.1.
- Adequate hematologic and organ function, as defined in protocol
- ECOG 0-1
- Primary platinum-refractory disease
- people with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, low-grade, borderline, or other ovarian tumors
- Any of the following treatment interventions within the specified time frame prior to C1D1:
- Major surgery within 28 days
- Hospitalization within 14 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 prescription or non-prescription drugs, or to discontinue consumption of food and herbal supplements that are strong or moderate CYP3A inhibitors and inducers or P-gp inhibitors at...
- Prior therapy with ZN-c3 or any other WEE1 inhibitor, ATR inhibitor, PKMYT1 inhibitor, or CHK1/2 inhibitor.
- A serious illness or medical condition(s) including, but not limited to:
- Clinically or radiographically unstable brain metastases or leptomeningeal disease that requires immediate treatment. people with asymptomatic brain metastases are eligible.
- Myocardial impairment resulting in heart failure (NYHA Class II-IV)
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with study participation or may interfere with interpretation of study results
- Acute kidney injury requiring intervention or intravenous fluid in the last 14 days or presence of indwelling urinary catheter or percutaneous nephrostomy.
- Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for intravenous alimentation, active peptic ulcer, chronic diarrhea or vomiting considered to be clinically...
- 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...
- Any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (CT scan, recent hospitalization for small bowel obstruction within 3 months prior to C1D1, or recurrent paracentesis or...
- Unresolved toxicity of Grade \>1 attributed to any prior therapies (excluding Grade ≤2 neuropathy, alopecia, or skin pigmentation).
- Pregnant or lactating female subject or female subject of childbearing potential who has a positive serum pregnancy test within 14 days prior to C1D1.
- 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, non-melanoma skin carcinoma...
- people who are known to be 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.
- people who had prior wide-field radiotherapy affecting ≥ 20% of the bone marrow.
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- La Jolla, California, United States
- Santa Barbara, California, United States
- Lone Tree, Colorado, United States
- Hartford, Connecticut, United States
- Daytona Beach, Florida, United States
- Lecanto, Florida, United States
- Miami Beach, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Savannah, Georgia, United States
- Niles, Illinois, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Rockville, Maryland, United States
- Boston, Massachusetts, United States
- Burlington, Massachusetts, United States
- Springfield, Massachusetts, United States
+ 64 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 Mobile, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; La Jolla, California, United States; Santa Barbara, California, United States; Lone Tree, Colorado, United States and 78 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.