Gastric Cancer
Conditions
Keywords
donafenib
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.
Interventions
200mg bid
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events | 54 weeks | patients with adverse events/all patients\*100% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response | 54 weeks | complete response and partial response patients/all patients\*100% |
| Progression-free survival time | 54 weeks | median progress-free survival time |
Countries
China
Outcome results
None listed