A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer

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

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.

Study Overview

• Status: Terminated
• Conditions: Oesophageal Cancer
• Intervention / Treatment: Drug: donafenib tosilate tablets

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Rongrui Liu, Doctor; Phone Number: 13911726595; Email: liurongrui@hotmail.com

Study Locations

• China
  • Beijing, China, 100071
    • Affiliated Cancer Center of Academy of Military Medical Sciences
    • Contact: Jianming Xu, Doctor; Phone Number: 86-13910866712; Email: jmxu2003@yahoo.com
    • Contact: Rongrui Liu; Phone Number: 86-13911726595; Email: liurongrui@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: donafenib tosilate tablets; 200mg bid	Drug: donafenib tosilate tablets; 200mg,bid; Other Names: CM4307

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse Events	percentage of any adverse events	54 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor response	Tumor evaluation by investigators according to RECIST 1.1 criteria	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.	54 weeks

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Investigators: Principal Investigator: Jianming Xu, Doctor, The Affiliated Hospital of Military Medical Science

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2015
• Primary Completion (Actual): October 29, 2020
• Study Completion (Actual): October 29, 2020

Study Registration Dates

• First Submitted: June 24, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimated): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: donafenib
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: ZGDE1B

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No