Spots Global Cancer Trial Database for A Phase I/II Clinical Study of SAF-189s in Non-small Cell Lung Cancer (NSCLC) Patients
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Trial Identification
Brief Title: A Phase I/II Clinical Study of SAF-189s in Non-small Cell Lung Cancer (NSCLC) Patients
Official Title: A Phase I/II, Multi-center Clinical Study: Dose-finding Phase I Study of Foritinib Succinate in Advanced ALK-positive NSCLC Patients and Phase II Study of Foritinib Succinate in ALK or ROS1-positive NSCLC Patients
Study ID: NCT04237805
Interventions
Study Description
Brief Summary: The study comprises two phases: phase I dose escalation (including PK run-in period and treatment period) and phase II study.
Detailed Description: This is a multicenter, single-arm, open-label dose-finding phase I/II study to determine the MTD and RP2D of oral foritinib succinate monotherapy in patients with advanced ALK-positive malignant solid tumor, and to evaluate the safety, tolerability, and PK characteristics of SAF-189s in patients with advanced ALK-positive NSCLC. Phase II clinical study was conducted to evaluate the efficacy, tumor activity, and safety of remitinib succinate in patients with ALK/ROS1 positive advanced non-small cell lung cancer, and to preliminary evaluate the population pharmacokinetic characteristics of remitinib succinate. This study consisted of two phases: phase I (including PK induction and continuous administration) and phase II, Phase I dose escalation : the patients with advanced ALK-positive malignant solid tumor who have progressed on standard therapies; Phase I study: histologically or cytologically confirmed, locally advanced ALK-positive and/or metastatic stage IIIB/IV NSCLC who have progressed on standard therapy; Phase II Study Part I: Patients with histologically and/or cytologically confirmed ALK or ROS1 positive locally-advanced and/or metastatic stage IIIb \~IV NSCLC;Patients who had not previously received or had received only one ALK/ROS1 inhibitor for disease progression or intolerance, and who had no more than 3 previous treatment lines overall Phase II Study Part Ⅱ: cohort1：ROS1-positive locally advanced and/or metastatic stage IIIB\~IV NSCLC patients diagnosed histologically and/or cytologically, with no prior systemic therapy or only one line of non-ROS1-inhibitor treatment cohort 2: patients with histologically and/or cytologically confirmed ROS1-positive locally advanced and/or metastatic stage IIIb \~IV NSCLC who had previously only received crizotinib as a ROS1 inhibitor for disease progression or intolerance and had no more than 3 overall previous treatment lines；
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
he First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China
Peking Union Medical College Hospital, Beijing, Beijing, China
Beijing Cancer Hospital, Beijing, Beijing, China
Beijing Chest Hospital,Capital Medical University, Beijing, Beijing, China
Guangdong Province People's General Hospital, Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center, Shenzhen, Guangdong, China
Affiliated Hospital of Hebei University, Baoding, Hebei, China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Zhengzhou Central Hospital, Zhengzhou, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology, Zhengzhou, Henan, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan, China
The Central Hospital of Yongzhou, Yongzhou, Hunan, China
Jiangsu Province Hospital, Nanjing, Jiangsu, China
General Hospital of Xuzhou Mining Group, Xuzhou, Jiangsu, China
The second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
The First Hospital of Jilin University, Changchun, Jilin, China
Jilin Cancer Hospital, Jilin, Jilin, China
Yanbian University Affiliated Hospital, Yanji, Jilin, China
The first affiliated hospital of China medical university, Shenyang, Liaoning, China
Jinan Central Hospital, Jinan, Shandong, China
No. 960 Hospital of the Joint Service Support Force of Chinese People's Liberation Army, Jinan, Shandong, China
Shandong Provincial Qianfoshan Hospital, Jinan, Shandong, China
Linyi Cancer Hospital, Linyi, Shandong, China
Shanghai Chest Hospital,Shanghai Jiaotong University, Shanghai, Shanghai, China
Jieyang Peoples Hospital, Jieyang, Shanxi, China
West China Hospital，Sichuan University, Chengdu, Sichuan, China
The second peoples hospital of Neijiang, Neijiang, Sichuan, China
Tianjin Medical University General Hospital, Tianjin, Tianjin, China
Tianjin Medical University Cancer Hospital, Tianjin, Tianjin, China
Tianjin Peoples Hospital, Tianjin, Tianjin, China
The First Affiliated Hospital, Medical School of Zhejiang University, Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, China
SIR RUN RUN SHAW HOSPITAL Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Shulan (Hangzhou) Hospital, Hangzhou, Zhengjiang, China
Contact Details
Name: Yilong Wu, Doctor
Affiliation: Guangdong Province People's General Hospital
Role: PRINCIPAL_INVESTIGATOR
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