Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer

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.

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.

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).