24 Participants Needed

NMS-03305293 + Topotecan for Ovarian Cancer

DR
Overseen ByDomenico Roberti
Age: 18+
Sex: Female
Trial Phase: Phase 1
Sponsor: Nerviano Medical Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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

I meet the specific requirements to participate.
I can do most of my daily activities on my own.
All side effects from my previous cancer treatments, except for hair loss, are mild or gone.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
1 visit (in-person)

Treatment

Participants receive NMS-03305293 orally twice daily and topotecan intravenously once weekly in repeated 4-week cycles

Approximately 6 months
Weekly visits for IV administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

Long-term follow-up

Participants are monitored for overall response rate, duration of response, progression-free survival, and overall survival

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • NMS-03305293
  • Topotecan
Trial Overview The study tests a new drug combo: NMS-03305293 with topotecan in patients whose ovarian cancer returned. It's an early-phase trial to find out the safest dose (Phase Ia) and then see how well it works (Phase Ib). Researchers will watch for any toxic reactions at different doses before checking its effectiveness against tumors.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: NMS-03305293 and TopotecanExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nerviano Medical Sciences

Lead Sponsor

Trials
14
Recruited
770+

Citations

Study of NMS-03305293 in Adult Patients With Relapsed ...The aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in ...
NMS-03305293 + Topotecan for Ovarian CancerThe aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in ...
Study of NMS-03305293 in Adult Patients With Relapsed ...The aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in ...
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NCT06930755 | Study of NMS-03305293 in Adult Patients ...The aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in ...
Study of NMS-03305293 in Adult Patients With Relapsed ...The aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in ...
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