A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer

Phase 1

Terminated

• Conditions: Oesophageal Cancer
• Interventions: Drug: donafenib tosilate tablets

• Registration Number: NCT02489201
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief 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.

Study Timeline

• Study First Submitted: 2015-06-24
• Study First Submitted QC: 2015-07-01
• Study First Posted: 2015-07-02
• Study Start: 2015-07-21
• Primary Completion: 2020-10-29
• Study Completion: 2020-10-29
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-13
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• All patients provided written, informed consent.
• Have histologically confirmed advanced oesophageal squamous-cell carcinoma, or type I/II Siewert junctional tumours.
• Have received up to two previous chemotherapy regimens( Platinum containing regimens & Paclitaxel / docetaxel containing regimens).
• Have an Eastern Cooperative Oncology Group Performance status of 0-1.
• Have ability to swallow tablets.
• no contraindications to sorafenib or donafenib.
• Have either measurable or evaluable lesion on CT.

Exclusion Criteria

• Patients with brain metastases.
• Patients receiving cytotoxic chemotherapy, immunotherapy or hormonal therapy, radiotherapy to site of measurable or evaluable disease within the previous 4 weeks.
• Patients had evidence of clinically active interstitial lung disease or abnormal blood results by predefined criteria (serum bilirubin >1.5 times upper limit of reference range, aspartate or alanine aminotransferase>2.5 times the upper limit of normal if no demonstrable liver disease) .

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
donafenib tosilate tablets	donafenib tosilate tablets	200mg bid

Primary Outcome Measures

Name	Time	Method
Number of participants with Adverse Events	54 weeks	percentage of any adverse events

Secondary Outcome Measures

Name	Time	Method
Tumor response	54 weeks	Tumor evaluation by investigators according to RECIST 1.1 criteria
Progression-free survival	54 weeks	PFS was defined as the time from date of randomization to disease progression radiological or death due to any cause, whichever occurs first. Subjects without progression or death at the time of analysis were censored at their last date of tumor evaluation.

Trial Locations

Locations (1)

Affiliated Cancer Center of Academy of Military Medical Sciences; 🇨🇳 Beijing, China