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

Erlotinib, Docetaxel, and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

Phase 1

Completed

Conditions: Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Stage III Squamous Cell Carcinoma of the Hypopharynx
Stage III Squamous Cell Carcinoma of the Larynx
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Nasopharynx
Stage III Squamous Cell Carcinoma of the Oropharynx
Stage III Verrucous Carcinoma of the Larynx
Stage III Verrucous Carcinoma of the Oral Cavity
Stage IV Squamous Cell Carcinoma of the Hypopharynx
Stage IV Squamous Cell Carcinoma of the Nasopharynx

Interventions: Drug: erlotinib hydrochloride
Drug: docetaxel
Radiation: radiation therapy
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Other: pharmacological study

First Posted Date: 2003-01-27

Last Posted Date: 2014-06-06

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 30

Registration Number: NCT00049283

Locations: 🇺🇸
Case Western Reserve University, Cleveland, Ohio, United States

Erlotinib in Treating Patients With Advanced Kidney Cancer

Phase 2

Completed

Conditions: Kidney Cancer

Interventions: Drug: OSI-774

First Posted Date: 2003-01-27

Last Posted Date: 2014-01-27

Lead Sponsor: The University of Texas Health Science Center at San Antonio

Target Recruit Count: 41

Registration Number: NCT00045487

Locations: 🇺🇸
University of Texas Health Science Center San Antonio, San Antonio, Texas, United States

Erlotinib Hydrochloride and Irinotecan Hydrochloride in Treating Patients With Advanced Solid Tumors

Phase 1

Active, not recruiting

Conditions: Adult Solid Neoplasm

Interventions: Drug: Erlotinib Hydrochloride
Drug: Irinotecan Hydrochloride

First Posted Date: 2003-01-27

Last Posted Date: 2025-02-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 60

Registration Number: NCT00045201

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

Phase 1

Completed

Conditions: Head and Neck Cancer

Interventions: Drug: cisplatin
Drug: erlotinib hydrochloride

First Posted Date: 2003-01-27

Last Posted Date: 2018-10-10

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 51

Registration Number: NCT00030576

Locations: 🇨🇦
Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada
🇨🇦
Princess Margaret Hospital, Toronto, Ontario, Canada
🇨🇦
Queen's University, Kingston, Ontario, Canada

and more 3 locations

Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer

Phase 3

Completed

Conditions: Pancreatic Cancer

Interventions: Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride

First Posted Date: 2003-01-27

Last Posted Date: 2020-04-02

Lead Sponsor: NCIC Clinical Trials Group

Target Recruit Count: 569

Registration Number: NCT00026338

Locations: 🇧🇷
Hospital Israelita Albert Einstein, Sao Paulo, Brazil
🇺🇸
Alta Bates Comprehensive Cancer Center, Berkeley, California, United States
🇺🇸
Loma Linda University Cancer Institute, Loma Linda, California, United States

and more 168 locations

Trastuzumab and Erlotinib as First-Line Therapy in Treating Women With Metastatic Breast Cancer Associated With HER2/Neu Overexpression

Phase 1

Completed

Conditions: Breast Cancer

Interventions: Biological: trastuzumab
Drug: erlotinib hydrochloride

First Posted Date: 2003-01-27

Last Posted Date: 2020-10-08

Lead Sponsor: Jonsson Comprehensive Cancer Center

Target Recruit Count: 27

Registration Number: NCT00033514

Locations: 🇺🇸
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States

Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Inoperable Stage III Non-Small Cell Lung Cancer

Phase 1

Terminated

Conditions: Adenocarcinoma of the Lung
Bronchoalveolar Cell Lung Cancer
Large Cell Lung Cancer
Squamous Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer

Interventions: Drug: erlotinib hydrochloride
Drug: cisplatin
Radiation: radiation therapy
Drug: etoposide
Drug: paclitaxel
Drug: carboplatin
Drug: docetaxel
Other: laboratory biomarker analysis

First Posted Date: 2003-01-27

Last Posted Date: 2013-02-01

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 48

Registration Number: NCT00042835

Locations: 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Erlotinib in Treating Patients With Malignant Mesothelioma of the Lung

Phase 2

Completed

Conditions: Advanced Malignant Mesothelioma
Epithelial Mesothelioma
Recurrent Malignant Mesothelioma
Sarcomatous Mesothelioma

Interventions: Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis

First Posted Date: 2003-01-27

Last Posted Date: 2013-01-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 55

Registration Number: NCT00039182

Locations: 🇺🇸
Southwest Oncology Group, San Antonio, Texas, United States

Erlotinib, Trastuzumab, and Paclitaxel in Treating Patients With Advanced Solid Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Interventions: Drug: paclitaxel
Biological: trastuzumab
Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis
Other: pharmacological study

First Posted Date: 2003-01-27

Last Posted Date: 2013-01-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 40

Registration Number: NCT00042809

Locations: 🇺🇸
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio, San Antonio, Texas, United States

Erlotinib in Treating Patients With Unresectable Liver Cancer and Liver Dysfunction

Phase 1

Completed

Conditions: Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer

Interventions: Drug: erlotinib hydrochloride
Other: pharmacological study
Other: laboratory biomarker analysis

First Posted Date: 2003-01-27

Last Posted Date: 2013-01-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 24

Registration Number: NCT00047346

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Drug Development Updates

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