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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date11 Mar 2021 |
优替德隆注射液联合贝伐珠单抗在非小细胞肺癌脑转移患者中的有效性和安全性的Ⅱ期临床试验
[Translation] Phase II clinical trial of the efficacy and safety of eutilide injection combined with bevacizumab in patients with brain metastases from non-small cell lung cancer
第一阶段
主要目的:
确定第一阶段扩展期及第二阶段联合给药方案;
比较两治疗组患者的颅内疗效。
次要目的:
比较两治疗组患者的其他颅内疗效及全身疗效;
比较两治疗组患者的安全性和耐受性。
第二阶段
主要目的:评价优替德隆注射液联合贝伐珠单抗在患者中的颅内疗效。
次要目的:
评价优替德隆注射液联合贝伐珠单抗在患者中的其他颅内疗效及全身疗效;
评价优替德隆注射液联合贝伐珠单抗在患者中的安全性和耐受性;
探索患者生活质量QOL的改善情况
[Translation] Phase I
Main purpose:
Determine the combined dosing regimen for the Phase I extension and Phase II;
Compare the intracranial efficacy of the two treatment groups.
Secondary purpose:
Compare other intracranial and systemic efficacy of the two treatment groups;
Compare the safety and tolerability of the two treatment groups.
Phase II
Main purpose: Evaluate the intracranial efficacy of Utidelon injection combined with bevacizumab in patients.
Secondary purpose:
Evaluate other intracranial and systemic efficacy of Utidelon injection combined with bevacizumab in patients;
Evaluate the safety and tolerability of Utidelon injection combined with bevacizumab in patients;
Explore the improvement of patients' quality of life QOL
优替德隆胶囊在晚期实体瘤患者中的耐受性I期临床试验
[Translation] Phase I clinical trial of tolerability of Utidelon capsules in patients with advanced solid tumors
主要目的:评价优替德隆胶囊在晚期实体瘤患者中的安全性和耐受性,确定最大耐受剂量和剂量限制性毒性。
次要目的:1.评价优替德隆胶囊相对于优替德隆注射液的绝对生物利用度; 2. 评价优替德隆胶囊在晚期实体瘤患者中的药代动力学特征; 3. 初步评价优替德隆胶囊在晚期实体瘤患者中的有效性和安全性; 4. 推荐后续临床试验给药剂量和给药方案。
[Translation] Primary objectives: To evaluate the safety and tolerability of Utidelon Capsules in patients with advanced solid tumors, and to determine the maximum tolerated dose and dose-limiting toxicity.
Secondary objectives: 1. To evaluate the absolute bioavailability of Utidelon Capsules relative to Utidelon Injection; 2. To evaluate the pharmacokinetic characteristics of Utidelon Capsules in patients with advanced solid tumors; 3. To preliminarily evaluate the efficacy and safety of Utidelon Capsules in patients with advanced solid tumors; 4. To recommend the dosage and dosing regimen for subsequent clinical trials.
优替德隆联合AC对比多西他赛联合AC用于HER2阴性早期高危或局部晚期乳腺癌新辅助化疗的Ⅲ期、开放、随机对照研究
[Translation] A phase III, open-label, randomized controlled study of eutilide combined with AC versus docetaxel combined with AC for neoadjuvant chemotherapy of HER2-negative early high-risk or locally advanced breast cancer
评估优替德隆联合多柔比星+环磷酰胺(AC)化疗方案对比多西他赛联合多柔比星+环磷酰胺(AC)方案用于HER2阴性早期高危或局部晚期乳腺癌新辅助化疗的疗效和安全性
[Translation] To evaluate the efficacy and safety of eutilide combined with doxorubicin + cyclophosphamide (AC) chemotherapy versus docetaxel combined with doxorubicin + cyclophosphamide (AC) chemotherapy for neoadjuvant chemotherapy of HER2-negative early high-risk or locally advanced breast cancer
100 Clinical Results associated with Chengdu Biostar Pharmaceuticals Ltd.
0 Patents (Medical) associated with Chengdu Biostar Pharmaceuticals Ltd.
100 Deals associated with Chengdu Biostar Pharmaceuticals Ltd.
100 Translational Medicine associated with Chengdu Biostar Pharmaceuticals Ltd.