Exploratory Objectives Sample Clauses

Exploratory Objectives. The exploratory objective of the First part (Part A) of this study is • To investigate the relationship between plasma AZD5363 exposure and plasma concentrations 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 cfDNA. • To obtain a p reliminary 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 PD 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 deoxyribonucleic acid (DNA) extraction for future exploratory research into genes/genetic variation that may influence response (i.e., distribution, safety, tolerability and efficacy) to AZD5363 treatment and/or susceptibility to cancer. This exploratory analysis will be reported separately.
Sample 1
AutoNDA by SimpleDocs
Exploratory Objectives. ‌ The exploratory objectives of this study are to examine the potential mechanisms of GSH by:  Evaluating changes in circulating GSH levels and in levels of other redox intermediates which are co-regulated with GSH (GSSH, cysteine, cystine, redox ratios and potential for the GSH and cysteine couples)  Evaluating changes occurring in up to 180 metabolites including acylcarnitines, amino acids, biogenic amines, monosaccharides, sphingolipids and glycerophospholipids as a result of changes in GI function associated with GSH administration.
Sample 1
Exploratory Objectives. 1. Evaluate the difference in disease progression according to RECIST 1.1 vs iRECIST (Appendix 5) criteria.
Sample 1
Exploratory Objectives. Frequency tables that include the proportion of patients who achieved clinical remission will be used to describe the proportion of patients that achieved clinical remission within the 12-month period. Clinical remission will be defined as meeting all the following: • No clinically significant asthma exacerbations during the 12-month period and; • No OCS use for asthma at the 12-month period and; • ACQ-5 < 1 at the end of 12-month period; and • Lung function stabilisation (no decline of ≥100 mL lung function measured using FEV1 compared to baseline) at 12 months. The change from baseline in FeNO will estimate the mean difference in FeNO at 1-, 3-, 6- , and 12-months and will use mixed effects models for repeated measures when appropriate (a similar approach as the one used for the primary objective). The change from baseline in FEV1 will estimate the mean difference in FEV1 at 1-, 3-, 6- , and 12-months and will use mixed effects models for repeated measures when appropriate (a similar approach as the one used for the primary objective). The change from baseline in blood eosinophil values will estimate the mean difference in blood eosinophil values from baseline and the ratio to baseline for blood eosinophil values at 1-, 3-, 6-, and 12-months. Both estimates will use mixed effects models for repeated measures when appropriate (a similar approach as the one used for the primary objective). Depending on data availability, exploratory objectives may only be described (as described in Section 3.7.1)
Sample 1
Exploratory Objectives. 1. To examine the efficacy of aramchol in improving imaging-based biomarkers associated with changes in NAFLD
Sample 1
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
Sample 1
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.
Sample 1
AutoNDA by SimpleDocs
Exploratory Objectives 
Sample 1

Related to Exploratory Objectives

  • Goals Goals define availability, performance and other objectives of Service provisioning and delivery. Goals do not include remedies and failure to meet any Service Goal does not entitle Customer to a Service credit.

  • Performance Objectives 4.1 The Performance Plan (Annexure A) sets out-

  • Objectives The objectives of this Agreement are to:

  • Targets a) Seller’s supplier diversity spending target for Work supporting the construction of the Project prior to the Commercial Operation Date is ____ percent (___%) as measured relative to Seller’s total expenditures on construction of the Project prior to the Commercial Operation Date, and;

  • Performance Targets Threshold, target and maximum performance levels for each performance measure of the performance period are contained in Appendix B.

  • Performance Measures The System Agency will monitor the Grantee’s performance of the requirements in Attachment A and compliance with the Contract’s terms and conditions.

  • Performance Goals A. The Trust and State Street have developed mutually acceptable performance goals dated March 1, 2011 , and as may be amended from time to time, regarding the manner in which they expect to deliver and receive the services under this Agreement (hereinafter referred to as “Service Level Agreement”). The parties agree that such Service Level Agreement reflects performance goals and any failure to perform in accordance with the provisions thereof shall not be considered a breach of contract that gives rise to contractual or other remedies. It is the intention of the parties that the sole remedy for failure to perform in accordance with the provisions of the Service Level Agreement, or any dispute relating to performance goals set forth in the Service Level Agreement, will be a meeting of the parties to resolve the failure pursuant to the consultation procedure described in Sections V. B. and V.C. below. Notwithstanding the foregoing, the parties hereby acknowledge that any party’s failure (or lack thereof) to meet the provisions of the Service Level Agreement, while not in and of itself a breach of contract giving rise to contractual or other remedies, may factor into the Trust’s reasonably determined belief regarding the standard of care exercised by State Street hereunder.

  • Development Milestones In addition to its obligations under Paragraph 7.1, LICENSEE specifically commits to achieving the following development milestones in its diligence activities under this AGREEMENT: (a) (b).

  • Performance Measure The specific representation of a process or outcome that is relevant to the assessment of performance; it is quantifiable and can be documented

  • Development and Regulatory Milestones With respect to each of the following milestones, Ikaria shall pay BioLineRx the corresponding payment set forth below within [**] days after the achievement by Ikaria, its Affiliates or Licensees of such milestone: MILESTONE PAYMENT

Time is Money Join Law Insider Premium to draft better contracts faster.