Ensartinib

Generic Name: Ensartinib

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₇Cl_₂FN_₆O_₃

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。

Associated Conditions: -

Associated Therapies: -

Clinical Trials

Expanded Access to Ensartinib for Participants With ALK+ NSCLC

Conditions: Non-Small Cell Lung Cancer
ALK 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

and more 1 locations

The Absorption, Metabolism and Excretion of [14C]Ensartinib in Human

Phase 1

Conditions: ALK-POSITIVE NSCLC

Interventions: Drug: Ensartinib

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

Phase 2

Active, not recruiting

Conditions: Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8
Lung Non-Squamous Non-Small Cell Carcinoma

Interventions: Drug: Alectinib
Drug: Crizotinib
Drug: Brigatinib
Drug: Ceritinib
Drug: Lorlatinib
Drug: Carboplatin
Drug: Cisplatin
Drug: Ensartinib
Drug: Pemetrexed

First Posted Date: 2018-11-13

Last Posted Date: 2024-11-13

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 10

Registration Number: NCT03737994

Locations: 🇺🇸
Miller-Dwan Hospital, Duluth, Minnesota, United States
🇺🇸
Fairview Southdale Hospital, Edina, Minnesota, United States
🇺🇸
Grady Memorial Hospital, Delaware, Ohio, United States

and more 487 locations

Treating Patients With Melanoma and ALK Alterations With Ensartinib

Phase 2

Active, not recruiting

Conditions: Melanoma

Interventions: Drug: Ensartinib
Diagnostic Test: ALKATI by Customized Nanostring Assay

First Posted Date: 2018-02-05

Last Posted Date: 2024-02-02

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 18

Registration Number: NCT03420508

Locations: 🇺🇸
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 1 locations

Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)

Phase 2

Active, not recruiting

Conditions: Recurrent Malignant Glioma
Recurrent Neuroblastoma
Malignant Solid Neoplasm
Recurrent Medulloblastoma
Recurrent Rhabdoid Tumor
Recurrent Soft Tissue Sarcoma
Refractory Malignant Germ Cell Tumor
Refractory Malignant Solid Neoplasm
Refractory Rhabdoid Tumor
Advanced Malignant Solid Neoplasm

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration and Biopsy
Procedure: Bone Scan
Procedure: Computed Tomography
Drug: Ensartinib
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Other: Pharmacological Study
Procedure: Positron Emission Tomography
Procedure: Radionuclide Imaging
Procedure: X-Ray Imaging

First Posted Date: 2017-07-11

Last Posted Date: 2025-01-08

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 98

Registration Number: NCT03213652

Locations: 🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸
Providence Alaska Medical Center, Anchorage, Alaska, United States
🇺🇸
Banner Children's at Desert, Mesa, Arizona, United States

and more 124 locations

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

Phase 2

Active, not recruiting

Conditions: Advanced Malignant Solid Neoplasm
Juvenile Xanthogranuloma
Langerhans Cell Histiocytosis
Malignant Glioma
Recurrent Childhood Rhabdomyosarcoma
Recurrent Ewing Sarcoma
Recurrent Osteosarcoma
Recurrent Primary Central Nervous System Neoplasm
Refractory Hepatoblastoma
Refractory Medulloblastoma

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Other: Laboratory Biomarker Analysis
Procedure: Bone Marrow Aspiration and Biopsy
Procedure: Mutation Carrier Screening
Drug: Larotrectinib Sulfate
Procedure: Bone Scan
Other: Pharmacological Study
Procedure: Computed Tomography
Drug: Olaparib
Drug: Palbociclib
Drug: Tipifarnib
Drug: Erdafitinib
Drug: Tazemetostat
Drug: Samotolisib
Drug: Selumetinib Sulfate
Drug: Ensartinib
Drug: Vemurafenib
Drug: Ulixertinib
Procedure: Magnetic Resonance Imaging
Drug: Selpercatinib
Procedure: Radionuclide Imaging
Procedure: Positron Emission Tomography
Procedure: X-Ray Imaging

First Posted Date: 2017-05-16

Last Posted Date: 2025-01-08

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 2316

Registration Number: NCT03155620

Locations: 🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸
Providence Alaska Medical Center, Anchorage, Alaska, United States
🇺🇸
Banner Children's at Desert, Mesa, Arizona, United States

and more 169 locations