Sorafenib dose escalation in treatment-naïve patients with metastatic renal cell carcinoma: a non-randomised, open-label, Phase 2b study.

Objective: To assess the efficacy and safety of sorafenib dose escalation in metastatic renal cell carcinoma (mRCC).

Patients And Methods: Intra-patient dose escalation may enhance the clinical benefit of targeted anticancer agents in metastatic disease. In this non-randomised, open-label, Phase 2b study, treatment-naïve patients with mRCC were initially treated with the standard oral sorafenib dose [400 mg twice daily (BID)].

Longitudinal mode competition and mode clustering in (Al,In)GaN laser diodes.

Longitudinal mode competition in (Al,In)GaN laser diodes at λ = 445nm and 515 nm with mode competition frequencies from 10 MHz to 150 MHz is observed. Up to two dozen lasing modes oscillate with the lasing mode rolling from the short wavelength edge to the long wavelength edge of the gain profile. The experimental results can be described very well with a set of multi-mode rate equations including self-, symmetric and asymmetric cross gain saturation.

Mode shaping in semiconductor broad area lasers by monolithically integrated phase structures.

By broadening the stripe width of the active waveguide region, it is possible to extract high optical powers from semiconductor broad area lasers. However, a weak output beam quality, optical filamentation, and high peak power densities will result, which are invoked by the amplification of higher order modes. We show an approach to influence the optical field inside the resonator by integrating optical phase structures directly into the waveguide.

Phase III, randomized, double-blind, placebo-controlled trial of gemcitabine/cisplatin alone or with sorafenib for the first-line treatment of advanced, nonsquamous non-small-cell lung cancer.

Purpose: This trial evaluated the efficacy and safety of sorafenib plus gemcitabine/cisplatin in chemotherapy-naive patients with unresectable stage IIIB to IV nonsquamous non-small-cell lung cancer (NSCLC).

Patients And Methods: Between February 2007 and March 2009, 904 patients were randomly assigned to daily sorafenib (400 mg twice a day) or matching placebo plus gemcitabine (1,250 mg/m(2) per day on days 1 and 8) and cisplatin (75 mg/m(2) on day 1) for up to six 21-day cycles. Because of safety findings from the Evaluation of Sorafenib, Carboplatin and Paclitaxel Efficacy in NSCLC (ESCAPE) trial, patients with squamous cell histology were withdrawn from the trial in February 2008 and excluded from analysis.

Measurement and simulation of filamentation in (Al,In)GaN laser diodes.

(Al,In)GaN-based laser diodes with ridge widths broader than a few micrometer tend to show filamentation effects in the lateral direction. By time-resolved scanning near-field optical microscopy, we find different kinds of filaments depending on ridge width and lateral position. We investigate these effects systematically and compare them to the results of corresponding simulations, which are based on a simple rate equation model including the lateral dimension.

Spectral dynamics of 405 nm (Al,In)GaN laser diodes grown on GaN and SiC substrate.

We investigate the spectral properties of violet 405 nm (Al,In)GaN laser diodes (LDs). Depending on the substrate the LDs are grown on, the lasing spectra show significant differences. LDs grown on low dislocation GaN substrate have a broad spectrum with several longitudinal modes, while LDs grown on SiC substrate are lasing on a single longitudinal mode.

Dermatomycoses of the glabrous skin : a double-blind, randomised, comparative trial of sertaconazole 2% cream once daily versus vehicle.

Objective: The aim of this multicentre, double-blind, vehicle-controlled study was to investigate the safety and efficacy of once-daily topical application of sertaconazole 2% cream compared with corresponding vehicle cream in the treatment of patients with tinea of glabrous skin.

Patients And Methods: A total of 400 patients were recruited at seven investigational sites; 144 patients in the intent-to-treat (ITT) population and 127 in the per-protocol (PP) population were treated for 3 weeks with either sertaconazole 2% once daily or corresponding vehicle cream. To evaluate therapeutic efficacy and safety, microscopic examination of native preparations, mycological cultures, and clinical assessment of the state of the lesion (objective and subjective monitoring of symptoms) were analysed after 3 weeks of treatment.

Nail penetration of sertaconazole with a sertaconazole-containing nail patch formulation.

Background And Objective: Sertaconazole, an imidazole antifungal drug, has been proven to have broad and potent antifungal activity. In the present study, the pharmacokinetics of sertaconazole nail patches, developed for treatment of onychodystrophy and onychomycosis, were investigated in healthy volunteers. The objective of the study was to investigate the penetration of sertaconazole into the nail and plasma and the residual sertaconazole concentration in patches after 1 week of application onto the nails.

Rate and extent of percutaneous absorption of sertaconazole nitrate after topical administration.

The purpose of this open study was to evaluate the rate and extent of the penetration of sertaconazole nitrate (CAS 99592-32-2, Zalaïn) penetration into the stratum corneum/lucidum of the human skin. Selected areas of 9 cm2 each of the back skin of 12 healthy volunteers were exposed over 8 different time intervals (between 0 and 48 h) to 100 mg of a 2% cream preparation of the compound or to placebo. Using a HPLC-assay the relative amounts of the applied dose of sertaconazole nitrate were determined in the residual cream of the skin surface as well as in 3 layers of the epidermis obtained by the stripping technique.