伊曲康唑和利福平对盐酸杰克替尼片在健康受试者中的药代动力学的影响研究
[Translation] Effects of itraconazole and rifampicin on the pharmacokinetics of jaktinib hydrochloride tablets in healthy subjects
主要目的:评价在健康受试者中伊曲康唑和利福平对盐酸杰克替尼及其主要代谢产物ZG0244和ZG0245的药代动力学(PK)的影响。
次要目的:评价在健康受试者中伊曲康唑和利福平对盐酸杰克替尼的安全性的影响。
[Translation] Primary objective: To evaluate the effects of itraconazole and rifampicin on the pharmacokinetics (PK) of Jaktinib hydrochloride and its major metabolites ZG0244 and ZG0245 in healthy subjects.
Secondary objective: To evaluate the effects of itraconazole and rifampicin on the safety of Jaktinib hydrochloride in healthy subjects.
盐酸杰克替尼片联合阿扎胞苷治疗骨髓增生异常综合征伴有骨髓纤维化或骨髓增生异常综合征/骨髓增殖性肿瘤伴有骨髓纤维化患者的安全性和有效性的多中心 I/II 期临床研究
[Translation] A multicenter phase I/II clinical study on the safety and efficacy of Jaktinib Hydrochloride Tablets combined with Azacitidine in the treatment of patients with myelodysplastic syndrome with myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasms with myelofibrosis
第 1 阶段:剂量递增
主要目的:评价盐酸杰克替尼片联合阿扎胞苷在骨髓增生异常综合征伴有骨髓纤维化或骨髓增生异常综合征/骨髓增殖性肿瘤伴有骨髓纤维化患者中的安全性和耐受性。确定II期推荐剂量(RP2D)。
次要目的:评价盐酸杰克替尼片联合阿扎胞苷在MDS伴MF或MDS/MPN伴 MF患者中的有效性。
探索性目的:探索MDS或MDS/MPN相关生物标志物与疗效的相关性。
第 2 阶段:剂量扩展
主要目的:评价盐酸杰克替尼片联合阿扎胞苷在MDS伴MF或MDS/MPN伴 MF患者中的有效性。
次要目的:评价盐酸杰克替尼片联合阿扎胞苷在MDS伴MF或MDS/MPN伴 MF患者中的安全性。
探索性目的:探索MDS或MDS/MPN相关生物标志物与疗效的相关性。
[Translation] Phase 1: Dose escalation
Primary objective: To evaluate the safety and tolerability of Jaktinib hydrochloride tablets combined with azacitidine in patients with myelodysplastic syndrome with myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasms with myelofibrosis. To determine the recommended dose (RP2D) for Phase II.
Secondary objective: To evaluate the efficacy of Jaktinib hydrochloride tablets combined with azacitidine in patients with MDS and MF or MDS/MPN with MF.
Exploratory objective: To explore the correlation between MDS or MDS/MPN-related biomarkers and efficacy.
Phase 2: Dose expansion
Primary objective: To evaluate the efficacy of Jaktinib hydrochloride tablets combined with azacitidine in patients with MDS and MF or MDS/MPN with MF.
Secondary objective: To evaluate the safety of Jaktinib hydrochloride tablets combined with azacitidine in patients with MDS and MF or MDS/MPN with MF.
Exploratory objective: To explore the correlation between MDS or MDS/MPN-related biomarkers and efficacy.
/ Not yet recruitingPhase 1/2 ZG005 联合盐酸吉卡昔替尼片在复发或难治性淋巴瘤患者中的多中心、开放、剂量探索和剂量扩展的I/II 期临床研究
[Translation] A multicenter, open-label, dose-finding and dose-expansion phase I/II clinical study of ZG005 combined with gecaxitinib hydrochloride tablets in patients with relapsed or refractory lymphoma
PART 1:
(1)探索ZG005 联合盐酸吉卡昔替尼片在复发或难治性淋巴瘤患者中的安全性;
(2)确认用于复发或难治性淋巴瘤的II 期推荐给药方案。
PART 2:
评价ZG005 联合盐酸吉卡昔替尼片在复发或难治性淋巴瘤的有效性。
[Translation] PART 1:
(1) Explore the safety of ZG005 combined with gecaxitinib hydrochloride tablets in patients with relapsed or refractory lymphoma;
(2) Confirm the recommended Phase II dosing regimen for relapsed or refractory lymphoma.
PART 2:
Evaluate the effectiveness of ZG005 combined with gecaxitinib hydrochloride tablets in relapsed or refractory lymphoma.
100 Clinical Results associated with Shanghai Zejing Pharmaceutical Technology Co., Ltd.
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