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Drug Highest PhasePhase 3 |
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SNG1005对比研究者选择化疗方案治疗既往经过脑转移治疗并出现新诊断软脑膜转移的HER2阴性乳腺癌患者的多中心、随机对照、开放标签临床试验
[Translation] A multicenter, randomized, controlled, open-label clinical trial of SNG1005 versus investigator's choice of chemotherapy in patients with HER2-negative breast cancer who have previously been treated for brain metastases and have newly diagnosed leptomeningeal metastases
比较两组的总生存期(OS);CNS(软脑膜和脑实质)的无进展生存期(PFS)、CNS(软脑膜和脑实质)在第3、6和12个月的临床获益率(疾病稳定或改善)、6个月和12个月的总体生存率、LC缓解率(RR)和缓解持续时间(DoR)、三阴性(HER2-/ER-/PR-)乳腺癌受试者的OS
安全性:确定SNG1005的安全性和耐受性。
[Translation] Compare the overall survival (OS) between the two groups; progression-free survival (PFS) in the CNS (leptomeninges and brain parenchyma), clinical benefit rate (disease stability or improvement) in the CNS (leptomeninges and brain parenchyma) at 3, 6, and 12 months, overall survival rate at 6 and 12 months, LC response rate (RR) and duration of response (DoR), OS in subjects with triple-negative (HER2-/ER-/PR-) breast cancer
Safety: Determine the safety and tolerability of SNG1005.
SNG1005对比研究者选择单药化疗治疗既往全脑放疗后脑实质进展的HER2阴性BCBM患者的多中心、随机对照、开放标签临床试验
[Translation] A multicenter, randomized, controlled, open-label clinical trial of SNG1005 versus investigator's choice of chemotherapy alone in patients with HER2-negative BCBM who have progressed in the brain parenchyma after prior whole-brain radiotherapy
比较两组的总生存期(OS); 比较两组的颅内、颅外的无进展生存期(PFS);比较两组颅内、颅外的客观缓解率(ORR);比较两组的颅内缓解持续时间(DoR)和第3和6个月DCR;比较两组颅外DoR;比较两组整体QoL
[Translation] Compare the overall survival (OS) between the two groups; Compare the intracranial and extracranial progression-free survival (PFS) between the two groups; Compare the intracranial and extracranial objective response rate (ORR) between the two groups; Compare the intracranial duration of response (DoR) and DCR at 3 and 6 months between the two groups; Compare the extracranial DoR between the two groups; Compare the overall QoL between the two groups
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