Study of NMS-03305293, a Non-Trapping PARP1-Specific PARP Inhibitor in Relapsed Ovarian Cancer
Nerviano Medical Sciences
Summary
This is a multicenter, open-label Phase Ia/b study on the safety and efficacy of the combination of NMS-03305293 and topotecan in patients with recurrent ovarian cancer, with dose-limiting toxicity (DLT) escalation. 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 combination with topotecan.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria - * Histologically confirmed diagnosis of high-grade serous epithelial ovarian, fallopian tube or peritoneal cancer. Sponsor might opt to restrict enrollment to either platinum refractory, primary or secondary platinum-resistant patients based on data emerging from the trial. * Patients must have received no more than 5 prior lines of therapy and failed all evidence based local standards of care as per Investigator judgment. Sponsor might opt to restrict prio lines of therapy to 3 in any moments, based on data emerging from the trial. * Eastern Cooperative Oncology Group (E…
Interventions
- DrugNMS-03305293
Route of administration: Oral
- DrugTopotecan
Route of administration: Intravenous
Locations (5)
- OSF Saint Francis Medical CenterPeoria, Illinois
- Washington University School of Medicine in St. LouisSt Louis, Missouri
- Penn Medicine - Perelman Center for Advanced MedicinePhiladelphia, Pennsylvania
- Tennessee OncologyNashville, Tennessee
- The University of Texas MD Anderson Cancer CenterHouston, Texas