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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
NMS-03305293
DrugRoute of administration: Oral
Topotecan
DrugRoute of administration: Intravenous
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: NMS-03305293 and TopotecanExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants with Adverse Events (AEs)
Evaluation of type, frequency, severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version 5.0), duration of AEs, first cycle DLT, electrocardiogram (ECG) and laboratory abnormalities and relationship of AE to study treatment
Time frame
Screening (Day ≤28) up to 28-day follow-up after end of treatment (Approximately 6 months)Secondary outcomes
1
Overall Response Rate (ORR)
Calculated as the proportion of evaluable patients who have achieved, as best overall response (BOR), complete response (CR) or partial response (PR) through Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Time frame
From the date of first response up to data cut-off (approximately 22 months)2
Duration of response (DoR)
Duration of response will be calculated from the date of either first CR or PR until the date of documented progression for patients who achieved CR or PR. Patients who died without report of progression will be considered non-events and censored at their last disease-free assessment date
Time frame
From the date of first response up to data cut-off (approximately 22 months)3
Progression-free survival (PFS)
Progression Free Survival will be calculated from the date of treatment initiation to the date of first documentation of disease progression, or death due to any cause, whichever occurs first
Time frame
From the date of treatment initiation up to data cut-off (approximately 24 months)4
Overall survival (OS)
Overall Survival will be calculated from the date of treatment initiation to the date of death due to any cause
Time frame
From the date of treatment initiation up to data cut-off (approximately 24 months)Sponsors and contacts
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Source ClinicalTrials.gov