Nt of advanced renal cell carcinoma and in Europe for the treatment of relapsed / refractory Rem mantle cell lymphoma. In DNA-PK Inhibitors a big s, global Phase 3 trial randomized patients with previously untreated advanced renal cell carcinoma and poor prognostic factors U have experienced once w Chentliche intravenously Se infusions of 25 mg of temsirolimus again significantly l Ngeres survive long progression-free overall survival than patients interferon alfa u again. This study was conducted to evaluate directly the effect of a single dose of temsirolimus 25 mg iv on the QT interval. According to the International Conference on Harmonization E14 guidance, an ideal, thorough QT study of drug-induced QT-Verl EXTENSIONS should recognize a placebo and a positive control drug with known effects on cardiac repolarization and analysis at supra-therapeutic doses.
Unfortunately, these study designs are often unm Possible, in patients with advanced cancer because of their non-therapeutic, heavy logistics and the need for targeted drug delivery Positive. Accordingly, it is for the assessment of QT of anticancer agents, stupid together Us as a single-dose studies in healthy volunteers. Because temsirolimus iv 25 mg has an acceptable safety and reps Possibility in healthy volunteers when administered as a sudden, it was m Was like, this placebo-controlled trial and moxifloxacin Lee in the therapeutic dose of RCC in a noncancer Bev Lkerung. The 25-mg dose was defined as the first test, h HIGHEST dose to be feasible and ethically justifiable, in healthy subjects, so that a supra-therapeutic dose, as I recommended for a thorough QT study was not included in this study.
Methods for studying the Bev Lkerung the f Rderf HIGEN subjects were healthy M Men or women aged 18 to 50, with a body mass index 18-30 kg/m2 and a K Body weight of 50 kg. The examiner determines the state of health to history, k Rperliche study, clinical results of laboratory tests, vital signs, ECG, and 12 is based. Subjects were excluded if they have any cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immune, dermatological, h Dermatological, neurological or psychiatric illness or medical or surgical conditions, the st Ren k can had with the distribution, metabolism or excretion of temsirolimus or moxifloxacin.
Exclusion criteria are other risk factors for TDP, a history of long QT syndrome, syncope, Krampfanf Fill or Unexplained Gardens cardiac death associated with a family member under 30 years no clinically relevant difference compared to normal limits, or QTc duration C470 ms women on the base of the machine, read the work Age at screening or on 2 Day. Study Design and Treatment This was a single dose, single-blind with respect to temsirolimus, crossover, placebo-controlled trial and moxifloxacin in a hospital It. The protocol was reviewed and approved by the Commission for the independent Independent verification of the Seaview Experimental Research, Inc in Plantation, Florida. A written Einverst Ndniserkl Tion was obtained from all subjects at the time of registration, and the study was conducted in accordance with the Declaration of Helsinki and its Performed changes. The subjects participated based on three consecutive periods of the test on a partially randomized sequence doses. Because of the per