High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer study: Azenosertib
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?
This is an investigational oral medicine being studied as a potential treatment for platinum-resistant high-grade serous ovarian, fallopian tube, or primary peritoneal cancer. It is designed to block a protein called WEE1, which may help stop cancer cells from repairing their DNA damage and lead to their death.
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 study is testing whether a drug called azenosertib works well. It also checks how safe the drug is and what side effects it causes.
- Who it's for
- You may be able to join if you have a specific type of ovarian cancer that no longer responds to platinum drugs.
- What's involved
- You would take the study drug. Your tumor must show a specific marker called Cyclin E1.
- Time commitment
- The source text does not say how long the study lasts or how many visits are needed.
- 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...
- people must have platinum-resistant disease
- 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...
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...
- 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;
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
- people must have platinum-resistant disease
- 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
- 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.
- 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.
- 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 is enrolling
- Mobile, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Lone Tree, Colorado, United States
- Hartford, Connecticut, United States
- Altamonte Springs, Florida, United States
- Miami Beach, Florida, United States
- Orlando, Florida, United States
- Wellington, Florida, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Boston, Massachusetts, United States
- Burlington, Massachusetts, United States
- Springfield, Massachusetts, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- Maplewood, Minnesota, United States
- Reno, Nevada, United States
- Rochester, New York, United States
+ 52 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, 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 Mobile, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Lone Tree, Colorado, United States; Hartford, Connecticut, United States; Altamonte Springs, Florida, United States and 66 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.