NMS-03305293 + Topotecan for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment combination for women with recurring ovarian cancer. It aims to assess the safety and effectiveness of combining an experimental drug, NMS-03305293, with an existing drug, topotecan, for treating this cancer type. The trial seeks participants with high-grade serous ovarian cancer who have tried up to five different treatments without success. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new experimental drug.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking certain medications, especially those that are anticancer agents, sensitive to CYP2D6 and CYP2C19, or known to prolong the QTc interval. If you are on full-dose anticoagulants, your dose must be stable for at least 2 weeks before joining. Please consult with the trial team to see if your specific medications are affected.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In a previous study, researchers aimed to determine the safety and tolerability of combining NMS-03305293 with topotecan for treating ovarian cancer. They focused on identifying side effects and assessing patient responses to the treatment. As this trial remains in the early stages, researchers continue to establish the optimal dose and monitor for serious side effects.
Topotecan, a chemotherapy drug approved for other cancers, has a well-known safety profile. However, NMS-03305293 is new and is being tested for safety and effectiveness when combined with topotecan. Detailed safety information about NMS-03305293 is not yet available, so this trial will help gather that data. Participation in these early trials aids doctors in understanding the treatment's safety.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of NMS-03305293 and Topotecan for ovarian cancer because it offers a novel approach compared to current treatments like chemotherapy and targeted therapies. Unlike standard treatments that primarily focus on killing cancer cells, NMS-03305293 targets specific pathways in the cancer cells, potentially leading to more effective and less toxic results. Additionally, this treatment combines an oral drug with an intravenous one, providing a unique administration method that might improve patient convenience and outcomes. This innovative combination could lead to new breakthroughs in managing ovarian cancer.
What evidence suggests that this trial's treatments could be effective for ovarian cancer?
Research has shown that topotecan, a chemotherapy drug, has produced mixed results in treating ovarian cancer. Approximately half of the studies found it beneficial, while the other half observed little improvement. This trial will administer a combination of NMS-03305293 and topotecan to determine if they can more effectively combat tumors together. The goal is to enhance the anti-tumor effects by using both drugs in tandem. Early results are under review, but the expectation is that this combination will outperform topotecan alone.12356
Are You a Good Fit for This Trial?
This trial is for adults with high-grade serous ovarian, fallopian tube, or peritoneal cancer that has come back. They should have tried no more than 5 treatments and not responded to standard care. Participants need an ECOG status ≤2 (which means they can walk and take care of themselves), measurable disease growth after recent therapy, and minimal side effects from past treatments.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive NMS-03305293 orally twice daily and topotecan intravenously once weekly in repeated 4-week cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall response rate, duration of response, progression-free survival, and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- NMS-03305293
- Topotecan
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nerviano Medical Sciences
Lead Sponsor