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MechanismGP IIb/IIIa stimulants [+1] |
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Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
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Active Org.- |
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Active Indication- |
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Drug Highest PhasePending |
First Approval Ctry. / Loc.- |
First Approval Date- |
评价盐酸多西环素片治疗晚期实体瘤患者的安全性、耐受性和药代动力学特征的Ⅰ期临床试验
[Translation] Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetics of doxycycline hydrochloride tablets in patients with advanced solid tumors
主要目的:评价盐酸多西环素片治疗晚期恶性实体瘤患者的安全性和耐受性,并观察最大耐受剂量,确定Ⅱ期临床试验推荐剂量。 次要目的: (1)评价盐酸多西环素片在晚期恶性实体瘤患者中的药代动力学特征。 (2)按照实体瘤疗效评价标准(RECIST 1.1),通过客观缓解率和疾病控制率初步评价盐酸多西环素片的抗肿瘤疗效。
[Translation] Main purpose: To evaluate the safety and tolerability of doxycycline hydrochloride tablets in the treatment of patients with advanced malignant solid tumors, to observe the maximum tolerated dose, and to determine the recommended dose for phase II clinical trials. Secondary objectives: (1) To evaluate the pharmacokinetics of doxycycline hydrochloride tablets in patients with advanced malignant solid tumors. (2) According to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1), the anti-tumor efficacy of doxycycline hydrochloride tablets was preliminarily evaluated through the objective response rate and disease control rate.
100 Clinical Results associated with Tianjin International Biomedicine Joint Research Institute
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