Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer

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

Detailed Description
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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.

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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Drug: donafenib tosilate tablets


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: donafenib tosilate tablets<br>200mg bid | Drug: donafenib tosilate tablets<br>* 200mg bid<br>* Other names: CM4307;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events | patients with adverse events/all patients*100% | 54 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response | complete response and partial response patients/all patients*100% | 54 weeks | 
| Progression-free survival time | median progress-free survival time | 54 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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donafenib