linifanib powerful antitumor effects. In a phase 1 monotherapy linifanib the safety and efficacy in patients with refractory showed Ren Asian solid tumors. Linifanib also showed antitumor activity AS-604850 t in phase 2 studies in patients with cancer, small cell lung cancer, hepatocellular Rem carcinoma or kidney cancer. This phase 1 study evaluated the pharmacokinetics, safety and contracts Possibility of linifanib in Japanese patients with solid tumors at doses Similar to those of the Phase 1 trial in Asian patients and led vorl an evaluation INDICATIVE Antitumoraktivit t. Patients and Methods Patients eligible patients aged 75-20 years were best with a tumor histologically or cytologically Saturated solid refractory R standard therapy or for which there are no effective standards, Eastern Cooperative Oncology Group performance status 0 2 and reasonable kidney, liver and bone marrow function.
Exclusion criteria kg K Bodyweight or B41 C63 kg, central nervous system left metastases, proteinuria greater than Grade 1 of the National AZD2171 Cancer Institute Common Terminology Criteria for Adverse Events version 3.0, hypertension, left ventricular Re ejection fraction 50, and serum positivity t To human immunodeficiency che virus or hepatitis B or C virus. Study design and treatment of this Phase 1 open-label, dose-escalation study of ethics committees and ethics committees of the H Pital National Cancer Center and was approved. In accordance with Good Clinical Practice guidelines and the Declaration of Helsinki All patients gave Einverst Ndnis before the study on the modality th Written.
The prime Re aim of the study was to assess the safety, reps Compatibility and pharmacokinetics of linifanib in Japanese patients with solid tumors. The secondary’re Goal was to create a vorl INDICATIVE evaluation of antitumor activity Obtain t. An exploratory analysis was performed to identify potential biomarkers that the activity of t Linifanib predict or serve as a substitute for the effects in clinical studies could identify linifanib future. A standard 3 3 Design determined dose assignment. 0.05, 0.10, 0.20 and 0.25 mg kg, administered in the morning: Patients were randomized to four successive cohorts t at once glicher administration of oral dosage units assigned linifanib. Dose of 0.
25 mg kg was the h Next dose planned to establish a uniform global Phase 2 dose, because a previous Phase 1 study in Japanese to a phase 2 kg recommended dose of 0.25 mg. Dose-limiting toxicity T was permanent as grade 4 neutropenia at screening and on day 1 of each cycle before the second treatment period after disease progression or until the last visit was defined. Complete response and partial response according to RECIST criteria have been defined, the objective response rate was defined as the proportion of patients with a best response of PR or CR in the studied population. Safety assessments included the results of laboratory tests and adv