A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer

Status Terminated

Clinical Trial Summary

This open-label, one-center, noncomparative, two-stages phase 1B trial assessed the tyrosine kinase inhibitor donafenib tosylate tablets(400 mg/d,200mg bid) in patients with advanced, inoperable oesophageal cancer progressing after chemotherapy . The primary endpoint is the safety.The secondary endpoints are tumor response and progression-free survival.

Clinical Trial Description

This open-label, noncomparative, two-part phase 1B trial recruited patients with advanced, inoperable oesophageal cancer. The primary objectives were to assess the safety for donafenib tosylate tablets .The secondary objectives were to estimate tumor response, progression-free survival, duration of response, and disease control rate (response plus stable disease); to evaluate changes in quality of life(QoL); This study is 2-stages designing. The investigators plan to enroll 19 patients in the first stage study. The investigators will start the secondary stage study if the disease control rate >=8/19. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02489201
Study type	Interventional
Source	Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	July 21, 2015
Completion date	October 29, 2020

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