Erlotinib

Generic Name: Erlotinib

Brand Names: Tarceva

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₃N_₃O_₄

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

Associated Therapies: -

Clinical Trials

A Study of LY2875358 in Japanese Participants With Advanced Cancer

Phase 1

Completed

Conditions: Solid Tumors
Lymphoma
Carcinoma, Non-Small-Cell Lung

Interventions: Biological: LY2875358
Drug: Erlotinib
Drug: Gefitinib

First Posted Date: 2012-05-18

Last Posted Date: 2015-06-08

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 17

Registration Number: NCT01602289

Locations: 🇯🇵
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Chiba, Japan

Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer

Phase 1

Completed

Conditions: Lung Cancer
Non Small Cell Lung Cancer (NSCLC)
Estrogen Receptor Breast Cancer
Breast Cancer

Interventions: Drug: entinostat
Drug: Erlotinib
Drug: Exemestane

First Posted Date: 2012-05-09

Last Posted Date: 2021-11-19

Lead Sponsor: Syndax Pharmaceuticals

Target Recruit Count: 14

Registration Number: NCT01594398

Locations: 🇺🇸
Sarah Cannon Research Institute, Nashville, Tennessee, United States
🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States
🇺🇸
Peggy and Charles Stephenson Cancer Center, Oklahoma City, Oklahoma, United States

Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

Phase 2

Completed

Conditions: Lung Adenocarcinoma
Brain Metastases

Interventions: Drug: erlotinib
Drug: pemetrexed
Drug: cisplatin

First Posted Date: 2012-04-17

Last Posted Date: 2015-01-26

Lead Sponsor: Guangzhou Medical University

Target Recruit Count: 69

Registration Number: NCT01578668

Locations: 🇨🇳
The first affiliated hospital of Guangzhou MC, Guangzhou, Guangdong, China

Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)

Phase 2

Completed

Conditions: Non Small Cell Lung Cancer

Interventions: Procedure: Stereotactic Radiosurgery
Drug: Erlotinib

First Posted Date: 2012-04-09

Last Posted Date: 2021-01-12

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 32

Registration Number: NCT01573702

Locations: 🇺🇸
Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
🇺🇸
University of California at San Francisco, San Francisco, California, United States
🇺🇸
University of Colorado Cancer Center, Aurora, Colorado, United States

and more 5 locations

Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma

Phase 2

Completed

Conditions: Lung Cancer

Interventions: Drug: Erlotinib
Drug: Pemetrexed

First Posted Date: 2012-03-28

Last Posted Date: 2014-09-15

Lead Sponsor: Si-Yu Wang

Target Recruit Count: 123

Registration Number: NCT01565538

Locations: 🇨🇳
Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

BELIEF (Bevacizumab and ErLotinib In EGFR Mut+ NSCLC)

Phase 2

Completed

Conditions: Lung Cancer

Interventions: Drug: Erlotinib
Drug: Bevacizumab

First Posted Date: 2012-03-23

Last Posted Date: 2022-08-24

Lead Sponsor: ETOP IBCSG Partners Foundation

Target Recruit Count: 109

Registration Number: NCT01562028

Locations: 🇫🇷
Centre Francois Baclesse, Caen, France
🇫🇷
Hôpital de Marseille, Marseille, France
🇩🇪
Thoraxklinik Heidelberg GmbH, Heidelberg, Germany

and more 45 locations

Lung Cancer in Women Treated With Anti-oestrogens anD Inhibitors of EGFR

Phase 2

Completed

Conditions: Stage IV Lung Cancer

Interventions: Drug: Gefitinib
Drug: Fulvestrant
Drug: Erlotinib

First Posted Date: 2012-03-16

Last Posted Date: 2021-01-08

Lead Sponsor: Intergroupe Francophone de Cancerologie Thoracique

Target Recruit Count: 379

Registration Number: NCT01556191

Locations: 🇫🇷
Clinique de l'Europe, Amiens, France
🇫🇷
Centre Antoine Lacassagne, Nice, France
🇫🇷
Hôpital Européen Georges Pompidou, Paris, France

and more 56 locations

Erlotinib Hydrochloride With or Without Bevacizumab in Treating Patients With Stage IV Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

Phase 2

Completed

Conditions: EGFR Exon 19 Deletion Mutation
EGFR NP_005219.2:p.L858R
Lung Non-Squamous Non-Small Cell Carcinoma
Stage IV Lung Non-Small Cell Cancer AJCC v7

Interventions: Drug: Erlotinib
Biological: Bevacizumab
Drug: Erlotinib Hydrochloride
Other: Laboratory Biomarker Analysis

First Posted Date: 2012-02-14

Last Posted Date: 2020-10-06

Lead Sponsor: Academic and Community Cancer Research United

Target Recruit Count: 88

Registration Number: NCT01532089

Locations: 🇺🇸
Rapid City Regional Hospital, Rapid City, South Dakota, United States
🇺🇸
State University of New York Upstate Medical University, Syracuse, New York, United States
🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States

and more 16 locations

Erlotinib in Combination With Pralatrexate in Advanced Malignancies

Phase 1

Completed

Conditions: Advanced Cancers
Solid Tumors

Interventions: Drug: Erlotinib
Drug: Pralatrexate

First Posted Date: 2012-02-13

Last Posted Date: 2016-07-04

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 72

Registration Number: NCT01532011

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy

Phase 3

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: afatinib
Drug: erlotinib

First Posted Date: 2012-02-01

Last Posted Date: 2019-02-15

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 795

Registration Number: NCT01523587

Locations: 🇭🇺
Pulmonology Institute of Veszprem County, Farkasgyepu, Farkasgyepü, Hungary
🇮🇳
Sri Ramachandra Medical College & Research Institute, Chennai, India
🇮🇳
B. P .Poddar Hospital & Medical Research Ltd., Kolkata, West Bengal, India

and more 187 locations

Drug Development Updates

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