Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02489214
• Other study ID #: ZGDG1B
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 16, 2016
• Est. completion date: June 13, 2019

Study information

• Verified date: November 2022
• 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-stage phase 1B trial assessed the donafenib in advanced gastric cancer.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: June 13, 2019
• Est. primary completion date: June 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• donafenib tosilate tablets
200mg bid

Locations

Country	Name	City	State
China	Affiliated Cancer Center of Academy of Military Medical Sciences	Beijing
China	The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu

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	patients with adverse events/all patients*100%	54 weeks
Secondary	Tumor response	complete response and partial response patients/all patients*100%	54 weeks
Secondary	Progression-free survival time	median progress-free survival time	54 weeks