Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer
ConditionOvarian Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorNerviano Medical Sciences
About this trial
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 criteria
Qualifiers
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 prior lines of therapy to 3 in any moments, based on data emerging from the trial.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Patient must have progressed radiographically on or after their most recent line of anticancer therapy and have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (radiologically measured by the Investigator).
Disqualifiers
Current enrollment in another interventional clinical trial.
Current treatment with other anticancer agents or devices.
BReast CAncer gene (BRCA) mutation.
Prior therapy with PARP inhibitor, outside of approved indication and schedules. Sponsor might opt to restrict prior use of PARP inhibitor (PARPi) in any moments, based on data emerging from the trial.
Trial design
Treatments tested in this trial
- NMS-03305293
- Topotecan
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov