Spots Global Cancer Trial Database for NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer

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Trial Identification

Brief Title: NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer

Official Title: A Phase II Open-Label Study of NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer

Study ID: NCT03146663

Conditions

Ovarian Cancer

Interventions

NUC-1031 500 mg

NUC-1031 750mg

Study Description

Brief Summary: This study was designed to evaluate the effect of two dose levels of NUC-1031 (500 mg/m2 and 750mg/m2) in patients with ovarian cancer. The primary objective was to determine the anti-tumor activity of NUC-1031 at the selected dose level (500 mg/m2 or 750 mg/m2).

Detailed Description: A total of 53 patients were randomized, of whom 51 patients were treated in Part I of the study, 24 patients in the 500 mg/m2 arm and 27 patients in the 750 mg/m2 arm. Eligible, consenting patients received NUC-1031 by IV infusion on Days 1, 8, and 15 of each 28-day cycle. Patients continued to receive NUC-1031 until the occurrence of disease progression and underwent imaging every 8 weeks. After disease progression, patients were followed for overall survival. Part II of the study was designed to select one of the treatment dose levels for further evaluation based on clinical and laboratory assessments of patients recruited in Part I. Despite promising efficacy and a good tolerability profile in Part I, it was decided not to initiate Part II as the pre-specified boundary for efficacy was uncertain to be met in this heavily pre-treated population with significant co-morbidities.