Exploratory Objectives Sample Clauses
Exploratory Objectives. To investigate the relationship between plasma AZD5363 exposure and plasma concentration of exploratory biomarkers and efficacy. Biomarkers may include, but are not restricted to, somatic mutation or amplification of genes on the PI3 Kinase and related pathways in circulating tumour plasma DNA (ctDNA). • To obtain a preliminary assessment of AZD5363 treatment effect by quantitative change in circulating tumour cells (CTCs). • To investigate the concordance of PIK3CA mutation status between per-patient analyses of blood and archival tumour tissue samples. • To explore changes in WHO performance status in patients treated with AZD5363 in combination with weekly paclitaxel compared with weekly paclitaxel plus placebo. • To collect optional matched pre-and post- treatment tumour biopsy samples to conduct assessment of the PDc effect of therapy compared to baseline. • To collect and store archival tumour samples and analyse surplus blood or tissue, for potential future exploratory research into factors that may influence development of cancer and/or response to AZD5363 (where response is defined broadly to include efficacy, tolerability or safety). Biomarkers may include, but are not restricted to, somatic mutation or amplification of genes on the PI3 kinase and related pathways, PTEN protein expression and AKT protein expression. This exploratory analysis will be reported separately. • To obtain blood samples for DNA extraction for future exploratory research into genes/genetic variation that may influence response (ie, distribution, safety, tolerability and efficacy) to AZD5363 treatment and/or susceptibility to cancer. This exploratory analysis will be reported separately.
Exploratory Objectives. To examine the efficacy of aramchol in improving imaging-based biomarkers associated with changes in NAFLD
Exploratory Objectives. To identify potential biomarkers including BRCA status, homologous recombination repair (HRR) gene status, HRD score, PD-L1 expression, and other disease-related or treatment-related biomarkers that would associate with tumor responses to the combination of TSR-042, bevacizumab, and niraparib based on the molecular profile of tumor tissue, blood, and optional ascitic fluid samples. • To evaluate the evolution of the molecular profile of the tumor and tumor microenvironment in response to treatment.
Exploratory Objectives. To evaluate the effect of OCA treatment on time to the first occurrence of individual components of the composite endpoint (outlined below): • All-cause death • Liver transplant • Hospitalization for hepatic decompensation based on first occurrence of: − Variceal bleed − Ascites (including hepatic hydrothorax and spontaneous bacterial peritonitis) − Hepatic encephalopathy
6.1. Overall Design
6.1.1. Design Diagram Figure 1: Design Schematic Studies 747-404/405
Exploratory Objectives. The exploratory objectives are: To determine the effect of QD TVB-2640 for 12 weeks versus placebo in subjects ▇▇▇▇ on clinical measures, including: – Liver fibrosis, as determined by vibration-controlled transient elastography (VCTE). – Metabolic parameters, including fasting glucose, insulin, homeostatic model assessment insulin resistance (HOMA2-IR), HbA1c, non-esterified fatty acid (NEFA), adipose tissue insulin resistance (adipo-IR), adiponectin, resistin, Interleukin 6 (IL-6), and gamma-glutamyl transpeptidase (GGT). – Anthropometric parameters, including weight, waist and hip circumference, waist-hip ratio, and blood pressure. – Lipidomic analyses for DNL. Explore the relationship of plasma drug exposure to changes in efficacy and safety biomarkers. Explore possible relationships between genomic markers of ▇▇▇▇ and responses to treatment.
Exploratory Objectives. Compare the detection of local and metastatic disease using [68Ga]FAPI-46 PET to a composite of clinical, radiological (i.e. CT, MR) and/or 18F-FDG PET and histopathological reference in patients with resectable or borderline resectable PDAC.
Exploratory Objectives. To assess PRO using the EORTC QLQ-C30, EQ-5D-5L, and Patient Global Impression of Severity (PGIS) questionnaires • To evaluate concentrations of MIRV, TAb, DM4 and S-methyl DM4, using sparse sampling • To assess the immunogenicity of MIRV via anti-drug antibodies (ADAs) • To evaluate potential biomarkers in blood and tumor tissue predictive of response to MIRV
Exploratory Objectives. The exploratory objectives of this study are to assess the effects of ricolinostat on IENFD, a potential biomarker for efficacy, at 24 weeks in a subset of patients with painful DPN who have reduced IENFD at baseline.
Exploratory Objectives. Patients must have platinum-resistant disease:
Exploratory Objectives. ● The pharmacokinetics (PK) of LB-100 and etoposide ● The biomarkers relevant to LB-100 and the disease state as well as their correlation to clinical outcomes