Entrectinib

Generic Name: Entrectinib

Brand Names: Rozlytrek

Drug Type: Small Molecule

Chemical Formula: C_₃₁H_₃₄F_₂N_₆O_₂

CAS Number: 1108743-60-7

Unique Ingredient Identifier: L5ORF0AN1I

Background: Entrectinib is a tropomyosin receptor tyrosine kinase (TRK) TRKA, TRKB, TRKC, proto-oncogene tyrosine-protein kinase ROS1, and anaplastic lymphoma kinase (ALK) inhibitor. It was approved by the FDA in August 2019 for use in the treatment of ROS1-positive metastatic non-small cell lung cancer and NTRK gene fusion positive solid tumors. Entrectinib's approved ...

Indication: Entrectinib is indicated for the treatment of metastatic ROS1-positive non-small cell lung cancer in adults. Entrectinib is also indicated in adults and children over 12 years old for the treatment of NTRK gene fusion-positive solid tumors which have metastasized or for which surgical resection is likely to result in severe morbidity and for which has progre...

Associated Conditions: Metastatic Non-Small Cell Lung Cancer, Metastatic Solid Neoplasm, Solid Tumors

Associated Therapies: -

Clinical Trials

Genetic Testing in Guiding Treatment for Patients With Brain Metastases

Phase 2

Recruiting

Conditions: Metastatic Malignant Neoplasm in the Brain
Metastatic Malignant Solid Neoplasm
PI3K Gene Mutation
KRAS G12C Mutation
NTRK Family Gene Mutation
CDK Gene Mutation
ROS1 Gene Mutation

Interventions: Drug: Entrectinib
Drug: PI3K Inhibitor paxalisib
Drug: Abemaciclib
Drug: Adagrasib

First Posted Date: 2019-06-21

Last Posted Date: 2024-10-26

Lead Sponsor: Alliance for Clinical Trials in Oncology

Target Recruit Count: 186

Registration Number: NCT03994796

Locations: 🇺🇸
Henry Ford Health Saint John Hospital, Detroit, Michigan, United States
🇺🇸
Henry Ford Saint John Hospital - Academic, Grosse Pointe Woods, Michigan, United States
🇺🇸
Henry Ford Saint John Hospital - Breast, Grosse Pointe Woods, Michigan, United States

and more 422 locations

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Phase 1

Terminated

Conditions: Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Anatomic Stage IV Breast Cancer AJCC v8
Anemia
Ann Arbor Stage III Hodgkin Lymphoma
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Castration-Resistant Prostate Carcinoma

Interventions: Drug: Abemaciclib
Drug: Abiraterone
Drug: Afatinib
Biological: Bevacizumab
Drug: Bicalutamide
Procedure: Biospecimen Collection
Drug: Bortezomib
Drug: Cabazitaxel
Drug: Cabozantinib
Drug: Capecitabine
Drug: Carboplatin
Drug: Celecoxib
Drug: Cobimetinib
Drug: Copanlisib
Drug: Dabrafenib
Drug: Dacomitinib
Drug: Darolutamide
Drug: Dasatinib
Drug: Doxorubicin
Biological: Durvalumab
Drug: Enasidenib
Drug: Entrectinib
Drug: Enzalutamide
Drug: Erlotinib
Drug: Everolimus
Drug: Fluorouracil
Drug: Idelalisib
Drug: Imatinib
Biological: Ipilimumab
Drug: Lenvatinib
Drug: Leucovorin
Drug: Lorlatinib
Drug: Losartan
Drug: Nab-paclitaxel
Drug: Neratinib
Biological: Nivolumab
Drug: Olaparib
Drug: Oxaliplatin
Drug: Palbociclib
Drug: Panobinostat
Biological: Pembrolizumab
Biological: Pertuzumab
Drug: Ponatinib
Other: Quality-of-Life Assessment
Drug: Regorafenib
Drug: Ruxolitinib
Drug: Sirolimus
Drug: Sorafenib
Drug: Sunitinib
Drug: Trametinib
Biological: Trastuzumab Emtansine
Drug: Tretinoin
Drug: Vemurafenib
Drug: Venetoclax
Drug: Vismodegib
Drug: Vorinostat

First Posted Date: 2019-03-18

Last Posted Date: 2024-03-04

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 2

Registration Number: NCT03878524

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

Phase 2

Active, not recruiting

Conditions: Cancer of Unknown Primary Site

Interventions: Drug: Alectinib
Drug: Vismodegib
Drug: Ipatasertib
Drug: Carboplatin
Drug: Olaparib
Drug: Erlotinib
Drug: Cisplatin
Drug: Bevacizumab
Drug: Gemcitabine
Drug: Vemurafenib
Drug: Cobimetinib
Drug: Trastuzumab Subcutaneous (SC)
Drug: Pertuzumab
Drug: Atezolizumab
Drug: Paclitaxel
Drug: Entrectinib
Drug: Ivosidenib
Drug: Pemigatinib

First Posted Date: 2018-04-13

Last Posted Date: 2024-06-14

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 528

Registration Number: NCT03498521

Locations: 🇦🇺
Northern Cancer Institute, St Leonards, New South Wales, Australia
🇦🇺
Blacktown Hospital, Blacktown, New South Wales, Australia
🇫🇮
Helsinki University Central Hospital; Dept of Oncology, Helsinki, Finland

and more 134 locations

Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients

Phase 1

Completed

Conditions: Advanced Solid Tumor

Interventions: Drug: Entrectinib
Drug: Midazolam Hydrochloride

First Posted Date: 2017-11-06

Last Posted Date: 2018-08-21

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 15

Registration Number: NCT03330990

Locations: 🇺🇸
SCRI-Denver Drug Development Program, Denver, Colorado, United States
🇺🇸
Florida Cancer Specialists - Sarasota (North Catttlemen Rd), Sarasota, Florida, United States
🇺🇸
Tennessee Oncology, Nashville, Tennessee, United States

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

Phase 2

Active, not recruiting

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Alectinib
Drug: Entrectinib
Drug: Atezolizumab
Drug: Divarasib
Drug: Cisplatin
Drug: Pemetrexed
Drug: Docetaxel
Drug: Cobimetinib
Drug: Gemcitabine
Drug: Carboplatin
Drug: Vemurafenib
Drug: Bevacizumab

First Posted Date: 2017-06-07

Last Posted Date: 2024-11-01

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 1000

Registration Number: NCT03178552

Locations: 🇺🇸
UC Davis; Comprehensive Cancer Center, Sacramento, California, United States
🇺🇸
Rocky Mountain Cancer Center, Denver, Colorado, United States
🇺🇸
SCRI Florida Cancer Specialists South, Fort Myers, Florida, United States

and more 174 locations

Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions

Conditions: Cancers With NTRK, ROS1, or ALK Gene Fusions

First Posted Date: 2017-02-28

Last Posted Date: 2019-04-26

Lead Sponsor: Hoffmann-La Roche

Registration Number: NCT03066661

Locations: 🇺🇸
1-844-Startrk (782-7875), San Diego, California, United States

The Drug Rediscovery Protocol (DRUP Trial)

First Posted Date: 2016-10-05

Last Posted Date: 2024-01-24

Lead Sponsor: The Netherlands Cancer Institute

Target Recruit Count: 1550

Registration Number: NCT02925234

Locations: 🇳🇱
Meander medisch centrum, Amersfoort, Netherlands
🇳🇱
Netherlands Cancer Institute, Amsterdam, Netherlands
🇳🇱
Amsterdam UMC, locatie AMC, Amsterdam, Netherlands

and more 33 locations

TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer

First Posted Date: 2016-02-26

Last Posted Date: 2024-11-11

Lead Sponsor: American Society of Clinical Oncology

Target Recruit Count: 3791

Registration Number: NCT02693535

Locations: 🇺🇸
University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham, Alabama, United States
🇺🇸
Cancer Treatment Centers of America-Phoenix, Phoenix, Arizona, United States
🇺🇸
Sutter Auburn, Auburn, California, United States

and more 125 locations

Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options

Phase 1

Active, not recruiting

Conditions: Solid Tumors
CNS Tumors

Interventions: Drug: Entrectinib

First Posted Date: 2016-01-08

Last Posted Date: 2024-09-27

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 69

Registration Number: NCT02650401

Locations: 🇺🇸
Children'S Hospital of Orange County, Orange, California, United States
🇺🇸
Egleston Children's Hospital at Emory University Atlanta; Pediatric Hematology/Oncology, Atlanta, Georgia, United States
🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

and more 37 locations

Capmatinib, Ceritinib, Regorafenib, or Entrectinib in Treating Patients With BRAF/NRAS Wild-Type Stage III-IV Melanoma

Phase 2

Terminated

Conditions: ALK Fusion Protein Expression
NRAS wt Allele
NTRK1 Fusion Positive
NTRK2 Fusion Positive
NTRK3 Fusion Positive
RET Fusion Positive
ROS1 Fusion Positive
Stage IV Cutaneous Melanoma
Stage IIIA Cutaneous Melanoma
Stage IIIB Cutaneous Melanoma

Interventions: Drug: Capmatinib
Drug: Ceritinib
Drug: Entrectinib
Other: Laboratory Biomarker Analysis
Drug: Regorafenib

First Posted Date: 2015-10-27

Last Posted Date: 2020-01-27

Lead Sponsor: University of California, San Francisco

Target Recruit Count: 1

Registration Number: NCT02587650

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

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