A randomized multi-center phase II trial of the angiogenesis inhibitor Cilengitide (EMD 121974) and gemcitabine compared with gemcitabine alone in advanced unresectable pancreatic cancer

BACKGROUND: Anti-angiogenic treatment is believed to have at least cystostatic effects in highly vascularized tumours like pancreatic cancer. In this study, the treatment effects of the angiogenesis inhibitor Cilengitide and gemcitabine were compared with gemcitabine alone in patients with advanced unresectable pancreatic cancer. METHODS: A multi-national, open-label, controlled, randomized, parallel-group, phase II pilot study was conducted in 20 centers in 7 countries. Cilengitide was administered at 600 mg/m(2 )twice weekly for 4 weeks per cycle and gemcitabine at 1000 mg/m(2 )for 3 weeks followed by a week of rest per cycle. The planned treatment period was 6 four-week cycles. The primary endpoint of the study was overall survival and the secondary endpoints were progression-free survival (PFS), response rate, quality of life (QoL), effects on biological markers of disease (CA 19.9) and angiogenesis (vascular endothelial growth factor and basic fibroblast growth factor), and safety. An ancillary study investigated the pharmacokinetics of both drugs in a subset of patients. RESULTS: Eighty-nine patients were randomized. The median overall survival was 6.7 months for Cilengitide and gemcitabine and 7.7 months for gemcitabine alone. The median PFS times were 3.6 months and 3.8 months, respectively. The overall response rates were 17% and 14%, and the tumor growth control rates were 54% and 56%, respectively. Changes in the levels of CA 19.9 went in line with the clinical course of the disease, but no apparent relationships were seen with the biological markers of angiogenesis. QoL and safety evaluations were comparable between treatment groups. Pharmacokinetic studies showed no influence of gemcitabine on the pharmacokinetic parameters of Cilengitide and vice versa. CONCLUSION: There were no clinically important differences observed regarding efficacy, safety and QoL between the groups. The observations lay in the range of other clinical studies in this setting. The combination regimen was well tolerated with no adverse effects on the safety, tolerability and pharmacokinetics of either agent

Detecting predictable non-linear dynamics in Dow Jones Islamic Market and Dow Jones Industrial Average indices using nonparametric regressions

This study performs the challenging task of examining the forecastability behavior of the stock market returns for the Dow Jones Islamic market (DJIM) and the Dow Jones Industrial Average (DJIA) indices, using non-parametric regressions. These indices represent different markets in terms of their institutional and balance sheet characteristics. The empirical results posit that stock market indices are generally difficult to predict accurately. However, our results reveal some point forecasting capacity for a 15-week horizon at the 95 per cent confidence level for the DJIA index, and for nine- week horizon at the 99 per cent confidence for the DJIM index, using the non-parametric regressions. On the other hand, the ratio of the correctly predicted signs (the success ratio) shows a percentage above 60 per cent for both indices which is evidence of predictability for those indices. This predictability is however statistically significant only four-weeks ahead for the DJIM case, and twelve weeks ahead for the DJIA as their respective success ratios differ significantly from the 50 percent, the expected percentage for an unpredictable time series. In sum, it seems that the forecastability of DJIM is slightly better than that of DJIA. This result on the forecastability of DJIM adds to its other findings in the literature that cast doubts on its suitability in hedging and asset allocation in portfolios that contain conventional stocks.http://www.journals.elsevier.com/the-north-american-journal-of-economics-and-finance/hb201

A round robin study of flexible large-area roll-to-roll processed polymer solar cell modules

A round robin for the performance of roll-to-roll coated flexible large-area polymer solar-cell modules involving 18 different laboratories in Northern America, Europe and Middle East is presented. The study involved the performance measurement of the devices at one location (Risø DTU) followed by transportation to a participating laboratory for performance measurement and return to the starting location (Risø DTU) for re-measurement of the performance. It was found possible to package polymer solar-cell modules using a flexible plastic barrier material in such a manner that degradation of the devices played a relatively small role in the experiment that has taken place over 4 months. The method of transportation followed both air-mail and surface-mail paths