Study endpoints
tumor, DLTs, death, Tumor
DISEASE PROGRESSION, TUMOR, TUMOR, ADVERSE EVENTS, EVENT, EVENTS
Tolerability and safety of camonsertib was evaluated by assessment of AEs, TEAEs, serious adverse events (SAEs), DLTs, concomitant medications and procedures, physical examinations, vital sign measurements, clinical safety laboratory evaluations (hematology, chemistry and urinalysis), ECOG performance status scores and electrocardiograms.The exploratory efficacy endpoint was assessment of anti-tumor activity by overall response rate, duration of treatment (DOT), CBR, PFS and overall survival. Overall response rate was defined as the proportion of patients with best response of complete response or PR according to RECIST 1.1, confirmed CA-125 response based on GCIG criteria or PSA response based on PCWG3. CBR was defined as the proportion of patients with a response by RECIST 1.1 or confirmed CA-125 by GCIG criteria or PSA response based on PCWG3 or a treatment duration of at least 16 weeks without prior evidence of progression (modification from the original protocol definition). Tumor responses were assessed according to RECIST 1.1 every 6 weeks for the first three assessments and thereafter every 9 weeks. Serum tumor biomarkers were assessed once per cycle or as per standard of care. For a tumor marker responder, there must also have been no evidence of radiologic or clinical progression before or within 4 weeks of the initial response. mPFS was calculated using the Kaplan–Meier method, where a disease progression per RECIST or death was treated as an event. Those patients without events were censored at their last tumor assessment date before the cutoff date. Similarly, to calculate mDOT, patients who discontinued treatment were treated as events, and those without events were censored at the data cutoff date.