MedPath

Erlotinib

Generic Name
Erlotinib
Brand Names
Tarceva
Drug Type
Small Molecule
Chemical Formula
C22H23N3O4
CAS Number
183321-74-6
Unique Ingredient Identifier
J4T82NDH7E
Background

Erlotinib is an inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase that is used in the treatment of non-small cell lung cancer, pancreatic cancer and several other types of cancer. It is typically marketed under the trade name Tarceva. Erlotinib binds to the epidermal growth factor receptor (EGFR) tyrosine kinase in a reversible fashion at the adenosine triphosphate (ATP) binding site of the receptor. Recent studies demonstrate that erlotinib is also a potent inhibitor of JAK2V617F, which is a mutant form of tyrosine kinase JAK2 found in most patients with polycythemia vera (PV) and a substantial proportion of patients with idiopathic myelofibrosis or essential thrombocythemia. This finding introduces the potential use of erlotinib in the treatment of JAK2V617F-positive PV and other myeloproliferative disorders.

Indication

Erlotinib is indicated for:

The safety and efficacy of erlotinib have not been established for patients with NSCLC whose tumors show other EGFR mutations. Additionally it is not recommended for use in combination with platinum-based chemotherapy.

Associated Conditions
Locally Advanced Pancreatic Cancer (LAPC), Metastatic Non-Small Cell Lung Cancer, Pancreatic Metastatic Cancer, Unresectable Pancreatic Cancer

EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC

Phase 3
Conditions
EGFR Gene Mutation
Interventions
First Posted Date
2016-09-01
Last Posted Date
2016-09-01
Lead Sponsor
Fujian Cancer Hospital
Target Recruit Count
120
Registration Number
NCT02886195

A Study of Erlotinib (Tarceva) in Participants With Non-Small Cell Lung Cancer (NSCLC)

Phase 2
Completed
Conditions
Non-Squamous Non-Small Cell Lung Cancer
Interventions
First Posted Date
2016-05-17
Last Posted Date
2016-08-08
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
264
Registration Number
NCT02774278

Docetaxel Versus Intercalated Erlotinib-docetaxel in Patients With Relapsed EGFR Wild Type, ALK Negative Non Squamous Cell Carcinoma

Phase 3
Terminated
Conditions
Carcinoma, Non-small Cell Lung
Interventions
First Posted Date
2016-05-17
Last Posted Date
2019-04-30
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
45
Registration Number
NCT02775006
Locations
🇳🇱

VUmc Medical Center, Amsterdam, Noord-Holland, Netherlands

🇳🇱

Erasmus MC, Rotterdam, Netherlands

🇳🇱

Laurentius Hospital, Roermond, Netherlands

and more 16 locations

Rapid Plasma Genotyping For Early Initiation Of Erlotinib In EGFR Mutant Lung Cancer

Phase 2
Terminated
Conditions
Epidermal Growth Factor Receptor
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2016-05-12
Last Posted Date
2019-11-22
Lead Sponsor
Dana-Farber Cancer Institute
Target Recruit Count
43
Registration Number
NCT02770014
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇸

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Compare Bevacizumab in Combination With Erlotinib Versus Erlotinib Alone in NSCLC Patients Activating EGFR Mutations

Phase 3
Conditions
NSCLC
Interventions
First Posted Date
2016-05-03
Last Posted Date
2018-06-25
Lead Sponsor
Guangdong Association of Clinical Trials
Target Recruit Count
311
Registration Number
NCT02759614
Locations
🇨🇳

Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China

RT Plus EGFR-TKI for Wild-type NSCLC

Phase 2
Conditions
Non-small Cell Lung Cancer
Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)
Interventions
Radiation: Radiotherapy
First Posted Date
2016-04-14
Last Posted Date
2016-04-14
Lead Sponsor
Hangzhou Cancer Hospital
Target Recruit Count
22
Registration Number
NCT02738983
Locations
🇨🇳

Hangzhou Cancer Hospital, Hangzhou, Zhejiang, China

Study of CG200745 PPA in Combination With Gemcitabine and Erlotinib for Advanced Pancreatic Cancer

Phase 1
Conditions
Pancreatic Neoplasms
Interventions
First Posted Date
2016-04-13
Last Posted Date
2019-06-17
Lead Sponsor
CrystalGenomics, Inc.
Target Recruit Count
24
Registration Number
NCT02737228
Locations
🇰🇷

Yonsei University Health System, Seoul, Korea, Republic of

Pemetrexed and Erlotinib for Metastatic Colorectal Cancer

Phase 2
Completed
Conditions
Metastatic Colorectal Cancer
Interventions
First Posted Date
2016-03-30
Last Posted Date
2020-01-13
Lead Sponsor
Yonsei University
Target Recruit Count
50
Registration Number
NCT02723578
Locations
🇰🇷

Yonsei University Health System, Severance Hospital, Seoul, Korea, Republic of

Thoracal Radiotherapy and Tarceva

Phase 2
Terminated
Conditions
Cancer
Interventions
Radiation: Radiation
First Posted Date
2016-03-21
Last Posted Date
2021-03-30
Lead Sponsor
Oslo University Hospital
Target Recruit Count
118
Registration Number
NCT02714530
Locations
🇳🇴

St Olavs Hospital, Trondheim, Norway

🇳🇴

Oslo University Hospital, Oslo, International/Other, Norway

Tarceva With or Without Apatinib in the Advanced Lung Adenocarcinoma

Phase 2
Conditions
Lung Cancer
Interventions
First Posted Date
2016-03-10
Last Posted Date
2016-03-10
Lead Sponsor
First Affiliated Hospital of Kunming Medical University
Target Recruit Count
60
Registration Number
NCT02704767
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