Phase I Clinical Study of Metatinib Tromethamine Tablet

NCT02004548 ↗

Phase 1 Completed 18 enrolled Jiangsu Simcere Pharmaceutical Co., Ltd.

NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: To evaluate the safety, tolerability and maximum tolerated dose (MTD) of daily oral administration of metatinib tromethamine in subjects with solid tumors; Investigate the influence of food on pharmacokinetic parameters. Secondary Objective: To evaluate the plasma pharmacokinetics (PK) of daily oral administration of metatinib tromethamine in subjects with solid tumors; To observe preliminary anti-tumor efficacy; To evaluate potential pharmacodynamic and predictive biomarkers at MTD.

Timeline

Start: 2013-05
Primary completion: 2015-09
Completion: 2015-12

Publications

Tabouret E, Fabbro M, Autran D, Hoang-Xuan K, Taillandier L, Ducray F, Barrie M, Sanson M, Kerr C, Cartalat-Carel S, Loundou A, Guillevin R, Mokhtari K, Figarella-Branger D, Delattre JY, Chinot O. TEMOBIC: Phase II Trial of Neoadjuvant Chemotherapy for Unresectable Anaplastic Gliomas: An ANOCEF Study. Oncologist. 2021 Aug;26(8):647-e1304. doi: 10.1002/onco.13765. Epub 2021 Apr 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metatinib Tromethamine	Unknown	25 mg	Oral
Subject	Metatinib Tromethamine	Unknown	50 mg	Oral
Subject	Metatinib Tromethamine	Unknown	100 mg	Oral
Subject	Metatinib Tromethamine	Unknown	200 mg	Oral
Subject	Metatinib Tromethamine	Unknown	300 mg	Oral
Subject	Metatinib Tromethamine	Unknown	450 mg	Oral
Subject	Metatinib Tromethamine	Unknown	600 mg	Oral
Subject	Metatinib Tromethamine	Unknown	800 mg	Oral

Indications

No indication recorded.