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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Route of administration: Oral
Route of administration: Intravenous
OSF Saint Francis Medical Center
Peoria, Illinois, United States
RECRUITINGWashington University School of Medicine in St. Louis
St Louis, Missouri, United States
RECRUITINGPenn Medicine - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
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)
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)
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)
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)
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)
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Tennessee Oncology
Nashville, Tennessee, United States
RECRUITINGThe University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGPlasma pharmacokinetic profile of NMS-03305293 and possible identified metabolites (if appropriate) after oral administration
Time frame: Cycle 1 - Days 1, 2, 5 and 6; Cycle 2 - Days 1 & 5. Each cycle is 28 days