硝呋莫司片在成年中枢神经系统肿瘤患者中评价耐受性、安全性、药代动力学及初步抗肿瘤活性的Ia期临床试验
[Translation] Phase Ia clinical trial of nifurolimus tablets to evaluate tolerability, safety, pharmacokinetics and preliminary antitumor activity in adult patients with central nervous system tumors
主要目的
评价硝呋莫司在经标准治疗后复发或疾病进展、或无标准治疗的成年高级别脑胶质瘤、髓母细胞瘤、脑转移瘤(包括但不限于肺癌脑转移、乳腺癌脑转移、黑色素瘤脑转移等)患者的耐受性、安全性,确定最大耐受剂量(MTD)和/或II期推荐剂量(RP2D)。
次要目的
1) 评价硝呋莫司在成年中枢神经系统肿瘤患者中的初步药代动力学特征;
2) 评价硝呋莫司在成年中枢神经系统肿瘤患者中的初步有效性。
探索性目的
探索硝呋莫司在成年中枢神经系统肿瘤患者中的给药方案。
[Translation] main purpose
Evaluation of nifurolimus in adult high-grade gliomas, medulloblastomas, brain metastases (including but not limited to lung cancer brain metastases, breast cancer brain metastases, Tolerance and safety of patients with melanoma brain metastases, etc.), determine the maximum tolerated dose (MTD) and/or phase II recommended dose (RP2D).
secondary purpose
1) To evaluate the preliminary pharmacokinetics of nifurolimus in adult patients with central nervous system tumors;
2) To evaluate the preliminary efficacy of nifurolimus in adult patients with central nervous system tumors.
exploratory purpose
To explore the dosing regimen of nifurolimus in adult patients with central nervous system tumors.
硝呋莫司治疗儿童复发或难治性神经母细胞瘤患者的单臂、非随机化、开放、剂量递增、I期临床试验
[Translation] A single-arm, non-randomized, open-label, dose-escalation, phase I clinical trial of nifurolimus in pediatric patients with relapsed or refractory neuroblastoma
主要目的
评价硝呋莫司单药及联合环磷酰胺及拓扑替康治疗儿童复发或难治性神经母细胞瘤患者的安全性,确定最大耐受剂量及 II 期推荐剂量。
次要目的
1) 评价硝呋莫司单药及联合用药的初步药代动力学特征;
2) 评价硝呋莫司联合用药治疗儿童复发或难治性神经母细胞瘤患者的缓解率。
探索性目的
探索硝呋莫司联合用药的最佳给药方案。
[Translation] main purpose
To evaluate the safety of nifurolimus alone or in combination with cyclophosphamide and topotecan in the treatment of children with relapsed or refractory neuroblastoma, and to determine the maximum tolerated dose and the recommended dose for phase II.
secondary purpose
1) To evaluate the preliminary pharmacokinetic characteristics of nifurolimus monotherapy and combination therapy;
2) To evaluate the response rate of nifurolimus combination therapy in children with relapsed or refractory neuroblastoma.
exploratory purpose
To explore the optimal dosing regimen of nifurolimus in combination.
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