Improving attribution of adverse events in oncology clinical trials.

Attribution of adverse events (AEs) is critical to oncology drug development and the regulatory process. However, processes for determining the causality of AEs are often sub-optimal, unreliable, and inefficient. Thus, we conducted a toxicity-attribution workshop in Silver Springs MD to develop guidance for improving attribution of AEs in oncology clinical trials.

Larotrectinib in adult patients with solid tumours: a multi-centre, open-label, phase I dose-escalation study.

Background: NTRK1, NTRK2 and NTRK3 gene fusions (NTRK gene fusions) occur in a range of adult cancers. Larotrectinib is a potent and highly selective ATP-competitive inhibitor of TRK kinases and has demonstrated activity in patients with tumours harbouring NTRK gene fusions.

Patients And Methods: This multi-centre, phase I dose escalation study enrolled adults with metastatic solid tumours, regardless of NTRK gene fusion status.

Phase I clinical trial of combination imatinib and ipilimumab in patients with advanced malignancies.

Background: Imatinib mesylate can induce rapid tumor regression, increase tumor antigen presentation, and inhibit tumor immunosuppressive mechanisms. CTLA-4 blockade and imatinib synergize in mouse models to reduce tumor volume via intratumoral accumulation of CD8+ T cells. We hypothesized that imatinib combined with ipilimumab would be tolerable and may synergize in patients with advanced cancer.

InstantLabs® Salmonella species detection method: matrix extension.

The performance of InstantLabs® Salmonella Species Food Safety Kit to detect Salmonella in four food matrixes was validated against the International Organization for Standardization (ISO) reference method 6579:2002. The matrixes (raw ground beef, raw chicken breast, raw ground chicken, and lettuce) were inoculated with low levels of Salmonella (<1 CFU/test portion) to generate fractional positives (5-15) in 20 inoculated samples. These matrixes were co-inoculated with Escherichia coli O157:H7 at two to five times the level of Salmonella.

InstantLabs®? Salmonella species food safety kit.

The InstantLabs® Salmonella Species Food Safety Kit was validated against the International Organization for Standardization (ISO) reference method* 6579:2002 for the detection of Salmonella species. The matrixes (unprocessed rolled oats, wheat flour, and oat flour) were inoculated with 1 CFU/test portion of Salmonella to generate fractional positives (5-15) in 20 inoculated samples. The inatrixes were co-inoculated with Escherichia coli O157:H7 at 2-5 times the level of Salmonella to demonstrate the potential for using the same enrichment culture in the future to detect of multiple organisms.