Assessment
Cancer
ADVERSE EVENTS, ADVERSE EVENT, BLOOD, CANCER
The National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.0) were used to grade adverse events. Blood samples were collected after single and multiple doses of CGA in all dose cohorts. Antitumor activities were assessed in all enrolled patients who received the first 28 days of treatment of CGA and for whom at least one post-treatment datapoint (brain MRI image) was available. Objective response and OS were summarized with descriptive statistics. The antitumor effects in patients were evaluated according to the Response Assessment in Neuro-Oncology Working Group criteria. The quality-of-life assessments were based on the European Quality of Life 5-Dimensions (EQ-5D) and Functional Assessment of Cancer Therapy (FACT-Br, version 4) questionnaires.Safety data were collected for all patients who received at least one dose of CGA injection during the first 28 days of treatment (full analysis set). All adverse events occurring during the first 4 weeks of treatment were included in the safety analysis. The National Cancer Institute Common Terminology Criteria for Adverse Events (Version 4.0) were used to grade adverse events. All adverse events occurring during the first 4 weeks of treatment were included in the safety analysis. Hematological assessments, urinalysis, 12-lead electrocardiography, assessments of KPS performance status, and quality-of-life questionnaire administration were performed at the initial screening, on day 1, day 16, and at the end of the 28-day treatment.