A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer

Phase 2TerminatedNCT02489201

Suzhou Zelgen Biopharmaceuticals Co.,Ltd19 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Oesophageal Cancer

Interventions

donafenib tosilate tabletsDRUG

200mg,bid

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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) .

Locations (1)

Affiliated Cancer Center of Academy of Military Medical Sciences

Beijing, China

Outcomes

Primary Outcomes

Number of participants with Adverse Events

percentage of any adverse events

Time frame: 54 weeks

Secondary Outcomes

Tumor response

Tumor evaluation by investigators according to RECIST 1.1 criteria

Time frame: 54 weeks

Progression-free survival

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.

Time frame: 54 weeks

Data from ClinicalTrials.gov

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