Ensartinib
- Generic Name
- Ensartinib
- Drug Type
- Small Molecule
- Chemical Formula
- C26H27Cl2FN6O3
- CAS Number
- 1370651-20-9
- Unique Ingredient Identifier
- SMA5ZS5B22
- Background
Ensartinib is under investigation in clinical trial NCT03420508 (Treating Patients With Melanoma and ALK Alterations With Ensartinib).
- Indication
用于此前接受过克唑替尼治疗后进展的或者对克唑替尼不耐受的间变性淋巴瘤激酶（ALK）阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者的二线治疗。
A Study of Ensartinib as Neoadjuvant Therapy for Patients With ALK Positive Resectable Non-Small Cell Lung Cancer
- First Posted Date
- 2022-05-18
- Last Posted Date
- 2022-08-18
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- Target Recruit Count
- 10
- Registration Number
- NCT05380024
- Locations
- 🇨🇳
Beijing Cancer Hospital, Beijing, Beijing, China
🇨🇳NAN Wu, Beijing, Beijing, China
Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer
- First Posted Date
- 2022-04-22
- Last Posted Date
- 2024-08-23
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Target Recruit Count
- 202
- Registration Number
- NCT05341583
- Locations
- 🇨🇳
TianJin Medical University Cancer Institute & Hospital, Tianjin, China
Adjuvant Therapy of Ensartinib in Stage IB-IIIA ALK-positive Non-small Cell Lung Cancer
- First Posted Date
- 2022-02-15
- Last Posted Date
- 2023-10-10
- Lead Sponsor
- Hebei Medical University Fourth Hospital
- Target Recruit Count
- 80
- Registration Number
- NCT05241028
- Locations
- 🇨🇳
Jun Feng Liu, Shijiazhuang, Hebei, China
Ensatinib Treat Second-generation ALK-TKI Resistance After Second-generation ALK-TKI Resistance
- Conditions
- Second Generation ALK-TKI is ResistantThe Diagnosis Was ALK Positive NSCLCEfficacy of Ensatinib in This Subset of Patients
- Interventions
- First Posted Date
- 2022-01-05
- Last Posted Date
- 2022-01-05
- Lead Sponsor
- Li Zhang, MD
- Target Recruit Count
- 40
- Registration Number
- NCT05178511
- Locations
- 🇨🇳
Sun Yat-sen University, Guangzhou, Guangdong, China
Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer
- Conditions
- Stage IIIC Lung Cancer AJCC v8Stage IVB Lung Cancer AJCC v8Metastatic Lung Non-Small Cell CarcinomaRecurrent Lung Non-Small Cell CarcinomaStage IV Lung Cancer AJCC v8Stage IVA Lung Cancer AJCC v8
- Interventions
- First Posted Date
- 2021-04-08
- Last Posted Date
- 2025-03-03
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 12
- Registration Number
- NCT04837716
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Expanded Access to Ensartinib for Participants With ALK+ NSCLC
- Conditions
- Non-Small Cell Lung CancerALK Gene Rearrangement Positive
- First Posted Date
- 2019-10-31
- Last Posted Date
- 2022-10-20
- Lead Sponsor
- Xcovery Holdings, Inc.
- Registration Number
- NCT04146571
- Locations
- 🇺🇸
Vanderbilt University, Nashville, Tennessee, United States
🇺🇸Stanford University, Stanford, California, United States
🇺🇸Walter Reed National Military Medical Center, Bethesda, Maryland, United States
The Absorption, Metabolism and Excretion of [14C]Ensartinib in Human
- First Posted Date
- 2019-01-15
- Last Posted Date
- 2019-01-15
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Target Recruit Count
- 6
- Registration Number
- NCT03804541
- Locations
- 🇨🇳
Jiangsu Province Hospital Affiliated to Nanjing Madical University of Medicine, Nanjing, Jiangsu Provence, China
Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer
- Conditions
- Stage IV Lung Cancer AJCC v8Stage IVA Lung Cancer AJCC v8Stage IVB Lung Cancer AJCC v8Lung Non-Squamous Non-Small Cell Carcinoma
- Interventions
- First Posted Date
- 2018-11-13
- Last Posted Date
- 2025-05-09
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 10
- Registration Number
- NCT03737994
- Locations
- 🇺🇸
Macomb Hematology Oncology PC, Warren, Michigan, United States
🇺🇸Kaiser Permanente-Richmond, Richmond, California, United States
🇺🇸Carle Cancer Center, Urbana, Illinois, United States
Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers
- Conditions
- Lung Cancer
- Interventions
- First Posted Date
- 2018-05-24
- Last Posted Date
- 2019-07-24
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Target Recruit Count
- 74
- Registration Number
- NCT03536481
- Locations
- 🇨🇳
Shanghai Public Health Clinical Center, Shanghai, Shanghai, China
A Study to Investigate the Food Effect on the Pharmacokinetics of Ensartinib Capsules in Chinese Healthy Volunteers.
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- First Posted Date
- 2018-04-27
- Last Posted Date
- 2019-07-24
- Lead Sponsor
- Betta Pharmaceuticals Co., Ltd.
- Target Recruit Count
- 24
- Registration Number
- NCT03510611
- Locations
- 🇨🇳
The 1st Phase Clinical Research Center of the Second Affiliated Hospital of Zhejiang University Medical College, Hangzhou, Zhejiang, China
Drug Development Updates
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