A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer

Oesophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02489201
• Other study ID #: ZGDE1B
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: July 21, 2015
• Est. completion date: October 29, 2020

Study information

• Verified date: June 2023
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: October 29, 2020
• Est. primary completion date: October 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) .

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Oesophageal Cancer

Intervention

Drug:
• donafenib tosilate tablets
200mg,bid

Locations

Country	Name	City	State
China	Affiliated Cancer Center of Academy of Military Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events	percentage of any adverse events	54 weeks
Secondary	Tumor response	Tumor evaluation by investigators according to RECIST 1.1 criteria	54 weeks
Secondary	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