Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer

Phase 1

Terminated

• Conditions: Gastric Cancer
• Interventions: Drug: donafenib tosilate tablets

• Registration Number: NCT02489214
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-06-25
• Study First Submitted QC: 2015-06-30
• Study First Posted: 2015-07-02
• Study Start: 2016-05-16
• Primary Completion: 2019-06-13
• Study Completion: 2019-06-13
• Status Verified: 2022-11
• Last Update Submitted: 2023-05-04
• Last Update Posted: 2023-05-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
donafenib tosilate tablets	donafenib tosilate tablets	200mg bid

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	54 weeks	patients with adverse events/all patients\*100%

Secondary Outcome Measures

Name	Time	Method
Tumor response	54 weeks	complete response and partial response patients/all patients\*100%
Progression-free survival time	54 weeks	median progress-free survival time

Trial Locations

Locations (2)

The Affiliated Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China

Affiliated Cancer Center of Academy of Military Medical Sciences; 🇨🇳 Beijing, China