ZN-c3 + Niraparib for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments, ZN-c3 (Azenosertib) and niraparib (Zejula, a PARP inhibitor), for ovarian cancer unresponsive to platinum-based therapies. The trial aims to assess the safety and effectiveness of these treatments, either alone or combined, in controlling cancer growth. Individuals with recurring high-grade ovarian, primary peritoneal, or fallopian tube cancer, who have not found a cure with current treatments, might be suitable candidates. Participants should be able to take oral medication and have measurable recurring cancer. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial requires a minimum of 10 days without prior PARP inhibitors before starting the new treatment. Additionally, you cannot take medications with a known risk of Torsades de Pointes (a type of heart rhythm problem).
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that ZN-c3, also known as azenosertib, is generally safe for people with platinum-resistant ovarian cancer. Research indicates that about 34.9% of patients respond to the treatment, and it is well-tolerated. These studies have reported no major safety concerns for ZN-c3.
For the combination of ZN-c3 and niraparib, research shows a similar response rate of around 35% in patients who have tried many other treatments. This suggests that the combination is also well-tolerated. The FDA has already approved niraparib for use in advanced ovarian cancer, confirming its safety in this context.
Overall, the available evidence suggests that both ZN-c3 alone and in combination with niraparib are safe for human use, with manageable side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about ZN-c3 and Niraparib for ovarian cancer because these treatments offer a unique approach compared to existing options. Unlike traditional chemotherapy, which broadly targets fast-growing cells, ZN-c3 is designed to inhibit a specific enzyme called Wee1, potentially stopping cancer cells from repairing themselves. Niraparib, a PARP inhibitor, works by preventing cancer cells from repairing their DNA, leading to cell death. The combination of these treatments targets cancer cells in a more focused way, potentially increasing effectiveness and minimizing damage to healthy cells. This novel strategy could offer new hope for patients with ovarian cancer who have limited options.
What evidence suggests that this trial's treatments could be effective for ovarian cancer?
Research has shown that ZN-c3, which participants in this trial may receive as monotherapy, may help treat ovarian cancer unresponsive to platinum-based treatments, with about 34.9% of patients experiencing tumor shrinkage or halted growth. Another treatment arm in this trial uses ZN-c3 combined with niraparib, a drug already approved for some ovarian cancers. The response rate for this combination is similar, at about 35% in patients who have undergone many previous treatments. These early results suggest that ZN-c3, both alone and with niraparib, could effectively manage this challenging condition.12346
Are You a Good Fit for This Trial?
This trial is for women aged 18+ with high-grade ovarian, peritoneal, or fallopian tube cancer that's resistant to platinum therapy. They must have relapsed within 6 months of treatment and be willing to provide tissue samples. Participants need measurable disease and good organ function but can't join if they have certain heart conditions, uncontrolled blood pressure, gastrointestinal issues affecting absorption, a history of MDS/AML or are on drugs with TdP risk.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Phase 1/2 study to evaluate the safety, clinical activity, pharmacokinetics (PK), and pharmacodynamics (PD) of ZN-c3 in combination with niraparib and ZN-c3 Monotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Niraparib
- ZN-c3
Niraparib is already approved in European Union, United States, Canada for the following indications:
- Maintenance treatment of adults with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy
- Maintenance treatment of adults with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
- Treatment of adults with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD)-positive status
- Maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
K-Group Beta
Lead Sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Lead Sponsor