A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer

NCT02489201 | Terminated Phase 1

• 1 other identifier: ZGDE1B
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Oesophageal Cancer

Keywords

donafenib

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse Events

  percentage of any adverse events

  54 weeks

Secondary Outcomes (2)

• Tumor response

  54 weeks

• Progression-free survival

  54 weeks

Study Arms (1)

donafenib tosilate tablets

EXPERIMENTAL

200mg bid

Drug: donafenib tosilate tablets

Interventions

donafenib tosilate tablets DRUG

200mg,bid

Also known as: CM4307

donafenib tosilate tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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) .

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Affiliated Cancer Center of Academy of Military Medical Sciences

Beijing, 100071, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

donafenib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Jianming Xu, Doctor

  The Affiliated Hospital of Military Medical Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 2, 2015
• Study Start: July 21, 2015
• Primary Completion: October 29, 2020
• Study Completion: October 29, 2020
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

CN (1)