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 Pertuzumab With Erlotinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Phase 1
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2015-07-23
Last Posted Date
2015-10-16
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
17
Registration Number
NCT02507375

A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)

Phase 1
Terminated
Conditions
Non-Small-Cell Lung Cancer
Interventions
First Posted Date
2015-07-13
Last Posted Date
2024-11-27
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
10
Registration Number
NCT02495233
Locations
🇯🇵

Site JP81005, Osakasayama, Osaka, Japan

🇯🇵

Site JP81004, Fukuoka Minami-ku, Fukuoka, Japan

🇯🇵

Site JP81003, Suntogun Nagaizumicho,Shizuoka, Japan

and more 1 locations

An Extension Study of Onartuzumab in Participants With Solid Tumors on Study Treatment Previously Enrolled in a Company Sponsored Study

Phase 3
Completed
Conditions
Solid Tumor
Interventions
First Posted Date
2015-07-02
Last Posted Date
2019-07-23
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
12
Registration Number
NCT02488330
Locations
🇫🇷

Hopital Roger Salengro, Lille, France

🇯🇵

National Hospital Organization Shikoku Cancer Center, Ehime, Japan

🇮🇹

Azienda Ospedaliero Universitaria San Giovanni Battista Di Torino, Torino, Piemonte, Italy

and more 7 locations

A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET Amplification

Phase 1
Terminated
Conditions
Non-Small Cell Lung Cancer
Interventions
Drug: INC280 single agent
First Posted Date
2015-06-11
Last Posted Date
2020-02-24
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
23
Registration Number
NCT02468661
Locations
🇺🇸

Henry Ford Hospital SC, Detroit, Michigan, United States

🇺🇸

Los Angeles Hematology/Oncology Medical Group, Los Angeles, California, United States

🇺🇸

University of California Irvine Medical Center Chao Family SC, Orange, California, United States

and more 4 locations

Local Therapies for Oligometastatic Non-Small Cell Lung Cancer Harboring Sensitizing EGFR Mutations

Not Applicable
Completed
Conditions
Oligometastatic Lung Adenocarcinoma
Interventions
Other: Local Therapies
First Posted Date
2015-05-21
Last Posted Date
2018-05-21
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
4
Registration Number
NCT02450591
Locations
🇺🇸

Memorial Sloan Kettering Westchester, Harrison, New York, United States

🇺🇸

Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre, New York, United States

🇺🇸

Memoral Sloan Kettering Cancer Center, Basking Ridge, New Jersey, United States

and more 4 locations

A Study of BGB324 (Bemcentinib) in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer

Phase 1
Completed
Conditions
Non-Small Cell Lung Cancer
Interventions
First Posted Date
2015-04-23
Last Posted Date
2025-02-26
Lead Sponsor
BerGenBio ASA
Target Recruit Count
40
Registration Number
NCT02424617
Locations
🇺🇸

UC San Diego Moores Cancer Center, La Jolla, California, United States

🇺🇸

USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States

🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

and more 7 locations

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

Phase 3
Active, not recruiting
Conditions
Metastatic Non-Small Cell Lung Cancer
Interventions
First Posted Date
2015-04-08
Last Posted Date
2025-04-20
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
545
Registration Number
NCT02411448
Locations
🇺🇸

UCLA Hematology/Oncology - Santa Monica, Los Angeles, California, United States

🇺🇸

AHN Allegheny General Hospital, Pittsburgh, Pennsylvania, United States

🇯🇵

Hyogo Prefectual Amagasaki General Medical Center, Amagashiki, Hyogo, Japan

and more 103 locations

Itacitinib in Combination With Erlotinib in Non Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Activating Mutations

Phase 2
Withdrawn
Conditions
Solid Tumors and Hematologic Malignancy
NSCLC (Non-small Cell Lung Carcinoma)
Interventions
First Posted Date
2015-02-04
Last Posted Date
2019-03-08
Lead Sponsor
Incyte Corporation
Registration Number
NCT02355431

A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer

Phase 3
Completed
Conditions
Non - Small Cell Lung Cancer NSCLC
Interventions
Drug: MEDI4736 (durvalumab)
Drug: MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4)
First Posted Date
2015-02-02
Last Posted Date
2024-07-26
Lead Sponsor
AstraZeneca
Target Recruit Count
597
Registration Number
NCT02352948
Locations
🇬🇧

Research Site, Wolverhampton, United Kingdom

Pacritinib in Patients With Endothelial Growth Factor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC) After EGFR Tyrosine Kinase Inhibitor (TKI)

Phase 1
Terminated
Conditions
Non-Small Cell Lung Cancer
Nonsmall Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Interventions
First Posted Date
2015-01-19
Last Posted Date
2018-02-27
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
8
Registration Number
NCT02342353
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

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