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

A Study of Erlotinib in Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer

Phase 3
Completed
Conditions
Pancreatic Cancer
Interventions
First Posted Date
2016-02-29
Last Posted Date
2017-03-24
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
80
Registration Number
NCT02694536

Bevacizumab and Erlotinib in Lung Cancer With Brain Metastases, a Phase II Trial

Phase 2
Conditions
Carcinoma, Non-Small-Cell Lung
Brain Neoplasms
Interventions
First Posted Date
2016-01-14
Last Posted Date
2018-07-10
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
109
Registration Number
NCT02655536
Locations
🇨🇳

Department of Oncology, Nationa Taiwan University Hospital, Taipei, Taiwan

Genomics-Based Target Therapy for Children With Relapsed or Refractory Malignancy

First Posted Date
2015-12-23
Last Posted Date
2020-03-19
Lead Sponsor
Samsung Medical Center
Target Recruit Count
90
Registration Number
NCT02638428
Locations
🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

Study Comparing Bevacizumab + Erlotinib vs Erlotinib Alone as First Line Treatment of Patients With EGFR Mutated Advanced Non Squamous Non Small Cell Lung Cancer

Phase 3
Active, not recruiting
Conditions
Non-squamous Non-small Cell Lung Cancer
Interventions
First Posted Date
2015-12-17
Last Posted Date
2023-03-24
Lead Sponsor
National Cancer Institute, Naples
Target Recruit Count
200
Registration Number
NCT02633189
Locations
🇮🇹

Ospedale Maggiore, Trieste, Italy

🇮🇹

A.O.U. Integrata, Verona, Italy

🇮🇹

A.S.O. SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy

and more 52 locations

Afatinib vs Erlotinib as 2nd TKI After Failure to 1st TKI and Chemotherapy for Metastatic NSCLC

Phase 2
Completed
Conditions
Lung Cancer
Interventions
First Posted Date
2015-12-09
Last Posted Date
2015-12-09
Lead Sponsor
The University of Hong Kong
Target Recruit Count
25
Registration Number
NCT02625168
Locations
🇭🇰

Department of Clinical Oncology, Queen Mary Hospital, Hong Kong, Hong Kong

A Non-interventional Trial of Erlotinib (Tarceva) Metastatic Non-small Cell Lung Cancer

Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2015-11-03
Last Posted Date
2016-01-25
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
299
Registration Number
NCT02595450

A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations

Phase 3
Terminated
Conditions
Non-small Cell Lung Cancer (NSCLC)
Interventions
First Posted Date
2015-10-27
Last Posted Date
2024-12-10
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
530
Registration Number
NCT02588261
Locations
🇺🇸

Site US10025, Fountain Valley, California, United States

🇺🇸

Site US10003, Santa Monica, California, United States

🇺🇸

Site US10013, Aventura, Florida, United States

and more 164 locations

A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)

First Posted Date
2015-10-12
Last Posted Date
2021-05-06
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
341
Registration Number
NCT02574078
Locations
🇺🇸

Cancer Care Center, Bismarck, North Dakota, United States

🇺🇸

Lehigh Valley Hospital, Allentown, Pennsylvania, United States

🇺🇸

Texas Oncology Cancer Center - Sugar Land, Sugar Land, Texas, United States

and more 119 locations

IMRT Combined With Erlotinib for EGFR Wild Type Non-small Cell Lung Cancer With 4-10 Brain Metastases

Phase 2
Terminated
Conditions
Non-Small Cell Lung Carcinoma
Interventions
Radiation: IMRT
Radiation: WBRT
First Posted Date
2015-09-22
Last Posted Date
2019-04-12
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
12
Registration Number
NCT02556593
Locations
🇨🇳

Hui Liu, Guangdong, China

Erlotinib Hydrochloride and Onalespib Lactate in Treating Patients With Recurrent or Metastatic EGFR-Mutant Non-small Cell Lung Cancer

Phase 1
Completed
Conditions
Recurrent Lung Non-Small Cell Carcinoma
Stage IV Lung Non-Small Cell Cancer AJCC v7
Interventions
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
First Posted Date
2015-08-28
Last Posted Date
2025-03-03
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
11
Registration Number
NCT02535338
Locations
🇺🇸

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

🇺🇸

Los Angeles General Medical Center, Los Angeles, California, United States

🇺🇸

City of Hope Comprehensive Cancer Center, Duarte, California, United States

and more 3 locations
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