Assessments
NSCLC, Tumors, tumour, Tumours, Toxicity, HNSCC, HGSOC, Cancer
ADVERSE EVENT, ADVERSE EVENTS, DISEASE, TUMORS, TUMOUR, NSCLC, CANCER
Safety assessments including adverse events, laboratory parameters, electrocardiograms (ECGs), and echocardiograms were conducted throughout treatment and until 30 days after the last study treatment or initiation of new anticancer treatment. Toxicity was recorded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.Serial sampling of blood for PK assessment was conducted before and after dosing with single-agent SRA737 (9 time points over 48 h) on Day −7 to Day −4 and on Cycle 1 Day 22; in addition, samples were drawn pre-dose on Days 1, 8, and 15 of Cycle 1, and pre-dose on Day 1 of each subsequent cycle. Plasma SRA737 concentrations were quantified using a fully validated liquid chromatography-mass spectrometry assay with a lower limit of quantitation of 5 ng/ml as previously described [Cardiac assessments included centrally-assessed serial ECGs in Cycle 1 used for evaluation of QTc. In addition, locally-read ECGs for safety assessment were also available for central assessment where clinically indicated. Troponin T or I assessments and echocardiogram were locally assessed.Genetic tumour profiling for eligibility was performed either from tumour tissue (FoundationOneRadiologic tumour assessments were carried out every 8 weeks, and clinical evaluations and serum tumour markers assessed every 4 weeks. Tumours were assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Clinical response data were summarized in cohorts defined by tumour type (CRC, HGSOC, NSCLC, mCRPC, HNSCC, or other disease).