NCT02489201

A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer

A Phase 1B Study of Donafenib Monotherapy in Advanced Oesophageal Cancer Progressing After Chemotherapy

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Oesophageal Cancer

Interventions

Type	Name	Description
DRUG	donafenib tosilate tablets	200mg,bid

Timeline

• Start date: 2015-07-21
• Primary completion: 2020-10-29
• Completion: 2020-10-29
• First posted: 2015-07-02
• Last updated: 2023-06-15

Locations

1 site across 1 country: China