Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer

May 4, 2023 updated by: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

A Phase 1B Study of Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer

This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the donafenib in advanced gastric cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the tyrosine kinase inhibitor donafenib tosilate tablets (400 mg/d,200mg bid) in patients with advanced, inoperable gastric cancer progressing after chemotherapy . The primary endpoint is the safety.The secondary endpoints are tumor response and progression-free survival time.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100071
        • Affiliated Cancer Center of Academy of Military Medical Sciences
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • The Affiliated Hospital of Nanjing University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients provided written, informed consent.
  • Have histological or cytological documentation of gastric adenocarcinoma;
  • Have received currently approved standard therapies and to have disease progression during or within 3 months after the last administration of the last standard therapy or to have stopped standard therapy because of unacceptable toxic effects.
  • Standard therapies include as many of the following as were licensed: a fluoropyrimidine,oxaliplatin,irinotecan, paclitaxel,docetaxel;and trastuzumab for patients who had Her-2 positive tumours;
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
  • Life expectancy of at least 3 months;
  • Have adequate bone-marrow, liver, and renal function at the start of the trial.
  • Prothrombin time international normalized ratio≤1.5；

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 54 weeks
patients with adverse events/all patients*100%
54 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response
Time Frame: 54 weeks
complete response and partial response patients/all patients*100%
54 weeks
Progression-free survival time
Time Frame: 54 weeks
median progress-free survival time
54 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Investigators

  • Principal Investigator: Bao Rui, Doctor, The Affiliated Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2016

Primary Completion (Actual)

June 13, 2019

Study Completion (Actual)

June 13, 2019

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZGDG1B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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