K evaluations should doses were performed with doses determined after the dose increase. Three doses of a single dose BX-912 PDK-1 Inhibitors and the dose for the study of multiple doses were between 8 to 12 participants for each of the weight Hlten doses needed to meet the SFDA advice. A cross-over design to evaluate the effects of food intake was included in the evaluation singledosing, also meet the requirement SFDA, but the data will be presented separately. Apatinib was Advenchen Laboratories, LLC, Capsule orally t Be made possible provided. The starting dose was determined as safe by the SFDA for a pre-determined maximum tolerated dose in dogs YN968D1 more than 30 mg / kg is recommended. Thus, in accordance with the SFDA, the recommended initial dose of 250 mg / day was identified, corresponding to a quarter of the MTD in dogs .
. The treatment cohort dose escalation, including five fifty-seven patients. Intra-patient dose escalation was not allowed. DLT was a grade 4 h Dermatological adverse events of grade 3 or non-h Dermatological AE defined in the first period TAK-960 1137868-52-0 of 4 weeks. If none of the first 3 patients developed DLT, further dose escalation. If one of the first 3 patients DLT, three additional patients were enrolled at the same dose. If none of the three other patients developed DLT at the same dose treated, further dose escalation. When two or three of the first 3 patients treated at a dose, or 1, 2 or 3 of 3 patients at a dose DLT does not develop, more dose escalation. The maximum tolerated dose was defined as the dose with h Defined at most two of six patients experience DLT.
Li et al. BMC Cancer 2010, 10:529 2407/10/529 Page 2 of 8 The treatment was determined by the dose-escalation phase, the progression of the disease withdrawal agreement, unertr Possible toxicity t or death. W During the dose reduction of long-term treatment was allowed if the toxicity of t for the patient experience. PK cohort enrolled 12 to 18 patients for the planned dose of 3 as determined by titration and the mean dose cohort continue the phone start-up Tzung type washing period after multiple doses. Evaluate the safety and reps Possibility of medical records and laboratory tests were obtained at screening. The k Rperliche examination, routine laboratory evaluations, and performance status were performed at baseline and at certain times w Evaluated during the study.
AEs and concomitant medication were recorded at the end of each cycle. The investigation period covered by the enhanced security at 30 days after the last dose of study medication or the recovery of grade 1 or more of all acute toxicity Ten S associated with the drug. The toxicity of t has been evaluated and graded according to NCI CTC for Adverse Events, version 3.0. The evaluation of patients with measurable disease, anti-tumor activity of t at the beginning of the study, for tumor response according to response evaluation criteria in solid tumors evaluated. Radiological studies to assess disease were carried out at the base and every 2 cycles thereafter. The best overall response rate was reported. Rate it controlled The disease as the percentage of patients with completely Ndigem response, partial response and stable disease for at least 8 weeks was defined. The total duration of response was defined as the period from the first measurement program