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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date19 Dec 1978 |
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MechanismDRIPs inhibitors |
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Inactive Indication- |
Drug Highest PhasePhase 1/2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
EN002外用凝胶剂在非黑色素瘤皮肤癌以及癌前病变患者中的耐受性、安全性、药物代谢动力学及初步有效性的Ⅰ-Ⅱ期临床试验研究
[Translation] Phase I-II clinical trial of EN002 topical gel to evaluate its tolerability, safety, pharmacokinetics and preliminary efficacy in patients with non-melanoma skin cancer and precancerous lesions
第一阶段
主要目的:
1) 评价EN002外用凝胶治疗非黑色素瘤皮肤癌的安全性和耐受性;
次要目的:
1)评价EN002外用凝胶在非黑色素瘤皮肤癌受试者中的药代动力学特征;
2)探索EN002外用凝胶治疗非黑色素瘤皮肤癌的疗效,为后续阶段试验给药剂量和给药方案提供依据;
第二阶段
主要目的:
1) 评价EN002外用凝胶治疗非黑色素瘤皮肤癌的抗肿瘤疗效,并确定适应症;
次要目的:
1) 评价EN002外用凝胶治疗非黑色素瘤皮肤癌的有效性和安全性;
2) 评价受试者的生活质量改善情况。
[Translation] Phase I
Main objectives:
1) To evaluate the safety and tolerability of EN002 topical gel in the treatment of non-melanoma skin cancer;
Secondary objectives:
1) To evaluate the pharmacokinetic characteristics of EN002 topical gel in subjects with non-melanoma skin cancer;
2) To explore the efficacy of EN002 topical gel in the treatment of non-melanoma skin cancer and provide a basis for the subsequent phase of trial dosing and administration regimen;
Phase II
Main objectives:
1) To evaluate the anti-tumor efficacy of EN002 topical gel in the treatment of non-melanoma skin cancer and determine the indications;
Secondary objectives:
1) To evaluate the efficacy and safety of EN002 topical gel in the treatment of non-melanoma skin cancer;
2) To evaluate the improvement of the quality of life of the subjects.
100 Clinical Results associated with Enkang Pharmaceutical Technology (Guangzhou) Co., Ltd.
0 Patents (Medical) associated with Enkang Pharmaceutical Technology (Guangzhou) Co., Ltd.
100 Deals associated with Enkang Pharmaceutical Technology (Guangzhou) Co., Ltd.
100 Translational Medicine associated with Enkang Pharmaceutical Technology (Guangzhou) Co., Ltd.