A Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer (NCT02426034) | Clinical Trial Compass
CompletedPhase 4
A Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer
China2,004 participantsStarted 2015-05-15
Plain-language summary
The large-scale phase IV study aims to verify the safety and efficacy of apatinib in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma after failure of two lines of chemotherapy. Apatinib initiated at a recommended dose of 850mg. However, the starting dose was decided by investigator's choice based on patients' condition. Dose interruption and dose reduction were allowed according to the product label. Treatment continued until disease progression, intolerable toxicity, withdrawal of informed consent, or at investigators' discretion. The primary endpoint was safety, which was assessed by recording the incidence and severity of adverse events.
Who can participate
Age range18 Years β 75 Years
SexALL
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Inclusion criteria
β. Age: 18 to75 years old;
β. Pathologically diagnosed with advanced gastric cancer (including adenocarcinoma of the gastroesophageal junction);
β. Failure of prior therapy (during or after treatment) in patients who have received at least two prior chemotherapy regimens;
β. ECOG PS of 0-2;
β. Major organ function has to meet the following criteria:
β. An expected survival of β₯ 3 months;
β. Patient received apatinib treatment regimen at investigators' discretion;
β. Patient has to voluntarily join the study and sign the Informed Consent Form for the study;
Exclusion criteria
β. Subjects with uncontrolled arterial hypertension (systolic blood pressure\> 140 mmHg and diastolic blood pressure \> 90 mm Hg) despite standard medical management; Grade β₯ 2 coronary heart disease; Grade β₯ 2 arrhythmia (including QT interval prolongation, for man \> 450 ms, for woman \> 470 ms), as well as Grade β₯ 2 cardiac dysfunction;
What they're measuring
1
Safety, which was assessed by recording the incidence and severity of adverse events
Timeframe: between first dose of apatinib and up to 30 days after the last dose of apatinib
β. Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
β. Subjects with high gastrointestinal bleeding risk, including the following conditions: presence of active ulceration combined with a positive fecal occult blood test (++);history of hematemesis and melena within three months before enrollment; unresected primary lesion in stomach with positive fecal occult blood test (+), ulcerated gastric carcinoma with massive alimentary tract bleeding risk judged by PIs based on gastric endoscopy finding;
β. Abnormal coagulation (INR\>1.5γAPTT\>1.5 UNL), with tendency of bleeding;
β. Presence of central nervous system metastases;
β. Pregnant or lactating women;
β. Other conditions regimented at investigators' discretion.