The Fuba Jixin (tnp-470) I Of Clinical Research

Objective : This phase I trial of TNP-470 determined the maximum-tolerated dose (MTD) ant pharmacokinetics of TNP-470 in patients with refractory solid tumors. Patients and MethodsTNP-470 was administered on days 1-5, days 8-12 and days 15-19, over one hour, repeated every 28 days for patients. The starting dose was 10 mg/m2/dose (n=3), with escalations to 20 (n =3), 35 (n=3), 45(n=96), 54(n=5), and 40(n=4) mg/m2/dose. The MTD was also evaluated. Pharmacokinetic sampling was performed after the first dose. ResultsTwenty-seven solid tumor patients were assessable for toxicity. The MTD was 54mg/m2/dose, and dose-limiting toxicity on cycle 1 was dyspnea. The common adverse reaction was insomnia. Other mild to moderate side effects induing headache, dizziness, nausea, vomiting, anorexia, and asthenia were observed. Twenty-two out of 27 patients were eligible for evaluation of response. The patients, one with metastatic adrenocortical carcinoma and the other with carcinoma of maxillary sinus, had minimal response. Nine patients had stable disease. The remaining patients had progression of their disease. The mean plasma half-lige (t1/2) of TNP-470 was extremely short. Conclusion...