|
MechanismTop II inhibitors |
|
|
|
|
Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date07 Aug 1974 |
高剂量组注射用盐酸多柔比星胶束治疗晚期实体肿瘤安全性的探索性研究
[Translation] An exploratory study on the safety of high-dose doxorubicin hydrochloride micelles for injection in the treatment of advanced solid tumors
主要目的:
1、在经标准治疗失败(疾病进展或无法耐受)或缺乏标准治疗的晚期实体肿瘤患者中确定注射用盐酸多柔比星胶束高剂量组的安全性。
次要目的:
1、探索注射用盐酸多柔比星胶束单药在晚期实体肿瘤患者中的药代动力学(PK)特征;
2、初步评价注射用盐酸多柔比星胶束高剂量组单药治疗晚期实体肿瘤的临床疗效;
3、与阳性药对照,比较二者的 PK 特征;
4、探索注射用盐酸多柔比星胶束的最大耐受剂量(MTD)。
[Translation] Main objectives:
1. To determine the safety of high-dose doxorubicin hydrochloride micelles for injection in patients with advanced solid tumors who have failed standard treatment (disease progression or intolerance) or lack standard treatment.
Secondary objectives:
1. To explore the pharmacokinetic (PK) characteristics of doxorubicin hydrochloride micelles for injection in patients with advanced solid tumors;
2. To preliminarily evaluate the clinical efficacy of high-dose doxorubicin hydrochloride micelles for injection in the treatment of advanced solid tumors;
3. To compare the PK characteristics of the two with positive drugs;
4. To explore the maximum tolerated dose (MTD) of doxorubicin hydrochloride micelles for injection.
注射用盐酸多柔比星胶束治疗晚期实体肿瘤的Ia期临床研究
[Translation] Phase Ia clinical study of doxorubicin hydrochloride micelles for injection in the treatment of advanced solid tumors
主要目的:在经标准治疗失败(疾病进展或无法耐受)或缺乏标准治疗的晚期实体肿瘤患者中确定注射用盐酸多柔比星胶束的安全性、最大耐受剂量(MTD)或IIa期推荐剂量(RP2D)。
次要目的:探索注射用盐酸多柔比星胶束单药在晚期实体肿瘤患者中的药代动力学(PK)特征;
初步评价注射用盐酸多柔比星胶束单药治疗晚期实体肿瘤的临床疗效;
与阳性药对照,比较二者的PK特征,并在剂量扩展阶段初步探索注射用盐酸多柔比星胶束单药治疗晚期乳腺癌、胃癌的临床优势。
[Translation] Primary objective: To determine the safety, maximum tolerated dose (MTD) or Phase IIa recommended dose (RP2D) of doxorubicin hydrochloride micelles for injection in patients with advanced solid tumors who have failed standard treatment (disease progression or intolerance) or lack standard treatment.
Secondary objective: To explore the pharmacokinetic (PK) characteristics of doxorubicin hydrochloride micelles for injection in patients with advanced solid tumors;
To preliminarily evaluate the clinical efficacy of doxorubicin hydrochloride micelles for injection in the treatment of advanced solid tumors;
To compare the PK characteristics of the two with the positive drug control, and to preliminarily explore the clinical advantages of doxorubicin hydrochloride micelles for injection in the treatment of advanced breast cancer and gastric cancer in the dose expansion phase.
100 Clinical Results associated with Curelong (Beijing) Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Curelong (Beijing) Pharmaceutical Co., Ltd.
100 Deals associated with Curelong (Beijing) Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Curelong (Beijing) Pharmaceutical Co., Ltd.