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A Study Evaluating Xilonix in Symptomatic Colorectal Cancer Patients Refractory To Standard Therapy

ABSTRACT: Primary Efficacy Endpoint: • The primary endpoint of this study will be the objective response rate (ORR), a composite measure consisting of change in lean body mass (LBM) and change in quality of life, from screening to week 8. The ORR will be defined as a stabilization or positive (≥0 kg) change in lean body mass (LBM)—as assessed by dual-energy X-ray absorptiometry (DEXA) scan, and improvement or no worsening (≥0 score point change) on any two of the three symptom scale measures (fatigue, pain, appetite) of EORTC QLQ-C30. Primary endpoints: The primary endpoint of this study will be the objective response rate (ORR), a composite measure consisting of change in lean body mass (LBM) and change in quality of life, from screening to week 8. The ORR will be defined as a stabilization or positive (≥0 kg) change in lean body mass (LBM)—as assessed by dual-energy X-ray absorptiometry (DEXA) scan, and improvement or no worsening (≥0 score point change) on any two of the three symptom scale measures (fatigue, pain, appetite) of EORTC QLQ-C30.

DISEASE(S): Colorectal Cancer,Symptomatic Colorectal Cancer

PROVIDER: 2532982 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Thiazolidinediones increase tissue insulin sensitivity and are protective against worsening of nephropathy and hypertension in diabetes. Mechanisms underlying protection at the renal level likely involve a variety of unknown changes in gene expression. We examined kidney gene expression in obese and lean Zucker rats in response to rosiglitazone (AvandiaÂ®), a peroxisome proliferator activated receptor (gamma-subtype) agonist. Lean and obese Zucker rats were treated with either control chow or chow with added rosiglitazone (3 mg/kgâ?¢bw) for 12 weeks (n = 3/group). Total kidney mRNA expression was evaluated using the Affymetrix Rat Genome 230 2.0 GeneChip. 903 probe sets were significantly (P < 0.05) altered with at least 1.5-fold changes between groups. In untreated obese rats, 300 probe sets were increased and 244 decreased, relative to lean. Increased genes included the Î²-subunit of the epithelial sodium channel (ENaC), the thiazide-sensitive Na-Cl cotransporter, and aquaporin 3. Decreased genes included angiotensin converting enzyme, type 1 (ACE1). FatiGO analysis showed that the highest number of altered genes between lean and obese belonged to the categories: ion binding, hydrolase activity, and protein binding. RGZ increased expression of uncoupling protein 1 (UCP1), CD36, and fatty acid binding protein 4 (FAbp4) in both lean and obese rats. In obese rats, 33 genes were normalized by RGZ (no longer different from lean) including ACE1, fatty acid synthase (Fasn), and stearoyl-coenzyme A desaturase 2 (Scd2). Ingenuity Pathways System analysis of genes upregulated by RGZ in obese rats revealed two major nodes affected: PPAR-gamma and tumor necrosis factor alpha (TNF-alpha). Experiment Overall Design: Twelve male Zucker rats (6 Lean and 6 Obese) were used in the study. Three rats from each body type were fed either with control diet (ground chow diet) or control diet with rosiglitazone (3 mg/kg body weight). The rats were weighed weekly and fed diets and recieved water ad libitum for 12 weeks.

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A Study Evaluating Xilonix in Symptomatic Colorectal Cancer Patients Refractory To Standard Therapy

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