Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer

Zelgen Biopharmaceuticals

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Gastric Cancer

Treatments

Drug: donafenib tosilate tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT02489214

ZGDG1B

Details and patient eligibility

About

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

Full 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.

Enrollment

13 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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).