Back to resultsA Study of Donafenib Monotherapy in Advanced Oesophageal Cancer
Primary Purpose
Oesophageal Cancer
Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
donafenib tosilate tablets
Sponsored by
About this trial
This is an interventional treatment trial for Oesophageal Cancer focused on measuring donafenib
Eligibility Criteria
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) .
Sites / Locations
- Affiliated Cancer Center of Academy of Military Medical Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
donafenib tosilate tablets
Arm Description
200mg bid
Outcomes
Primary Outcome Measures
Number of participants with Adverse Events
percentage of any adverse events
Secondary Outcome Measures
Tumor response
Tumor evaluation by investigators according to RECIST 1.1 criteria
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.
Full Information
NCT ID
NCT02489201
First Posted
June 24, 2015
Last Updated
June 13, 2023
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02489201
Brief Title
A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer
Official Title
A Phase 1B Study of Donafenib Monotherapy in Advanced Oesophageal Cancer Progressing After Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Corporate policy adjustments
Study Start Date
July 21, 2015 (Actual)
Primary Completion Date
October 29, 2020 (Actual)
Study Completion Date
October 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oesophageal Cancer
Keywords
donafenib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
donafenib tosilate tablets
Arm Type
Experimental
Arm Description
200mg bid
Intervention Type
Drug
Intervention Name(s)
donafenib tosilate tablets
Other Intervention Name(s)
CM4307
Intervention Description
200mg,bid
Primary Outcome Measure Information:
Title
Number of participants with Adverse Events
Description
percentage of any adverse events
Time Frame
54 weeks
Secondary Outcome Measure Information:
Title
Tumor response
Description
Tumor evaluation by investigators according to RECIST 1.1 criteria
Time Frame
54 weeks
Title
Progression-free survival
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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) .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianming Xu, Doctor
Organizational Affiliation
The Affiliated Hospital of Military Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Cancer Center of Academy of Military Medical Sciences
City
Beijing
ZIP/Postal Code
100071
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer
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