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

Clinical Trials

A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR

Phase 3

Terminated

Conditions: NSCLC Patients With EGFR Activating Mutation

Interventions: Drug: ERLOTINIB WITH CHEMOTHERAPY
Drug: CHEMOTHERAPY ONLY

First Posted Date: 2014-06-30

Last Posted Date: 2017-07-17

Lead Sponsor: Centre Francois Baclesse

Target Recruit Count: 6

Registration Number: NCT02178397

Locations: 🇫🇷
CH, Villefranche, France
🇫🇷
CHRU, Angers, France
🇫🇷
CHU, Rouen, France

and more 12 locations

Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery

Phase 2

Terminated

Conditions: Bladder Carcinoma
Recurrent Bladder Carcinoma

Interventions: Drug: Erlotinib Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other: Placebo
Other: Quality-of-Life Assessment
Procedure: Therapeutic Conventional Surgery

First Posted Date: 2014-06-23

Last Posted Date: 2020-07-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 50

Registration Number: NCT02169284

Locations: 🇺🇸
Lahey Hospital and Medical Center, Burlington, Massachusetts, United States
🇺🇸
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
🇺🇸
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States

and more 3 locations

Trial of Ruxolitinib and Erlotinib in Patients With EGFR-mutant Lung Adenocarcinoma With Acquired Resistance to Erlotinib

Phase 1

Completed

Conditions: Lung Cancer

Interventions: Drug: Ruxolitinib
Drug: Erlotinib

First Posted Date: 2014-06-04

Last Posted Date: 2019-01-16

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 22

Registration Number: NCT02155465

Locations: 🇺🇸
Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States
🇺🇸
Memoral Sloan Kettering Cancer Center at Phelps, Sleepy Hollow, New York, United States
🇺🇸
Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States

and more 3 locations

Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer

Completed

Conditions: Recurrent Squamous Cell Lung Carcinoma
Stage IV Squamous Cell Lung Carcinoma AJCC v7

Interventions: Drug: Erlotinib Hydrochloride
Biological: Durvalumab
Drug: Docetaxel
Drug: FGFR Inhibitor AZD4547
Biological: Ipilimumab
Other: Laboratory Biomarker Analysis
Drug: Palbociclib
Drug: Taselisib
Biological: Nivolumab
Biological: Rilotumumab
Other: Pharmacological Study
Drug: Talazoparib
Biological: Tremelimumab

First Posted Date: 2014-06-03

Last Posted Date: 2023-06-01

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 1864

Registration Number: NCT02154490

Locations: 🇺🇸
Riverside Methodist Hospital, Columbus, Ohio, United States
🇺🇸
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
🇺🇸
Los Angeles County-USC Medical Center, Los Angeles, California, United States

and more 997 locations

Gemcitabine and Pulse Dose Erlotinib in Second Line Treatment of Advanced Pancreatic Cancer

Phase 1

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: Gemcitabine
Drug: Erlotinib

First Posted Date: 2014-06-03

Last Posted Date: 2021-03-02

Lead Sponsor: Tony Reid, M.D., Ph.D.

Target Recruit Count: 24

Registration Number: NCT02154737

Locations: 🇺🇸
UCSD Moores Cancer Center, La Jolla, California, United States

A Study of Abemaciclib (LY2835219) in Participants With Previously Treated KRAS Mutated Lung Cancer

Phase 3

Active, not recruiting

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Erlotinib
Drug: Abemaciclib

First Posted Date: 2014-06-02

Last Posted Date: 2025-04-22

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 453

Registration Number: NCT02152631

Locations: 🇺🇸
St Joseph Cancer Center, Englewood, Colorado, United States
🇧🇷
Hospital Bruno Born, Lajeados, Brazil
🇺🇸
Indiana University School of Medicine, Indianapolis, Indiana, United States

and more 69 locations

A Phase II Study to Assess Efficacy of Combined Treatment With Erlotinib (Tarceva) and Silybin-phytosome (Siliphos) in Patients With EGFR Mutant Lung Adenocarcinoma

Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Erlotinib
Dietary Supplement: Silybin-phytosome

First Posted Date: 2014-05-23

Last Posted Date: 2014-05-23

Lead Sponsor: MedicalLogic

Target Recruit Count: 42

Registration Number: NCT02146118

Locations: 🇰🇷
Gosin University Gospel Hospital, Busan, Korea, Republic of

Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC

Phase 3

Conditions: EGFR Mutation
NSCLC

Interventions: Drug: Erlotinib

First Posted Date: 2014-05-16

Last Posted Date: 2015-02-12

Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Target Recruit Count: 220

Registration Number: NCT02140333

Locations: 🇨🇳
Guangzhou medical university, Guanzhou, Guangdong, China

Erlotinib Hydrochloride in Treating Non-Small Cell Lung Cancer That is Metastatic or Cannot be Removed by Surgery in Patients With HIV Infection

Phase 1

Terminated

Conditions: HIV Infection
Recurrent Non-Small Cell Lung Carcinoma
Stage IIIA Non-Small Cell Lung Cancer
Stage IIIB Non-Small Cell Lung Cancer
Stage IV Non-Small Cell Lung Cancer

Interventions: Drug: Erlotinib Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Other: Quality-of-Life Assessment

First Posted Date: 2014-05-09

Last Posted Date: 2015-10-06

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 48

Registration Number: NCT02134886

Locations: 🇺🇸
University of California San Diego, San Diego, California, United States
🇺🇸
UCLA Center for Clinical AIDS Research and Education, Los Angeles, California, United States
🇺🇸
Albert Einstein College of Medicine, Bronx, New York, United States

and more 2 locations

Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)

Phase 3

Terminated

Conditions: Lung Cancer
Non-small Cell Lung Cancer

Interventions: Drug: Erlotinib
Drug: Patritumab
Drug: Placebo

First Posted Date: 2014-05-08

Last Posted Date: 2018-01-23

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 145

Registration Number: NCT02134015

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