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 in Treating Patients With Liver Cancer That Cannot be Surgically Removed

Phase 2

Terminated

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

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

First Posted Date: 2003-01-27

Last Posted Date: 2013-01-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 80

Registration Number: NCT00047333

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

Erlotinib in Treating Patients With Persistent or Recurrent Cancer of the Cervix

Phase 2

Completed

Conditions: Cervical Squamous Cell Carcinoma
Recurrent Cervical Cancer

Interventions: Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis

First Posted Date: 2003-01-27

Last Posted Date: 2013-01-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 51

Registration Number: NCT00031993

Locations: 🇺🇸
Gynecologic Oncology Group, Philadelphia, Pennsylvania, United States

Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction

Phase 1

Completed

Conditions: Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Adult Anaplastic Oligodendroglioma
Adult Brain Stem Glioma
Adult Diffuse Astrocytoma
Adult Ependymoblastoma
Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Adult Mixed Glioma

Interventions: Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis

First Posted Date: 2003-01-27

Last Posted Date: 2013-01-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 75

Registration Number: NCT00030498

Locations: 🇺🇸
Cancer and Leukemia Group B, Chicago, Illinois, United States

Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer

Phase 2

Completed

Conditions: Esophageal Cancer
Gastric Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2013-06-24

Lead Sponsor: SWOG Cancer Research Network

Registration Number: NCT00032123

Locations: 🇺🇸
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, United States
🇺🇸
Veterans Affairs Medical Center - West Los Angeles, Los Angeles, California, United States
🇺🇸
Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, United States

and more 104 locations

Erlotinib in Treating Patients With Locally Advanced or Metastatic Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2013-06-19

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT00030537

Locations: 🇺🇸
Center for Cancer Research, Bethesda, Maryland, United States
🇺🇸
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States

Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer

Phase 2

Completed

Conditions: Adenocarcinoma of the Esophagus
Adenocarcinoma of the Gastroesophageal Junction
Recurrent Esophageal Cancer
Squamous Cell Carcinoma of the Esophagus
Stage III Esophageal Cancer
Stage IV Esophageal Cancer

Interventions: Drug: erlotinib hydrochloride
Other: laboratory biomarker analysis

First Posted Date: 2003-01-27

Last Posted Date: 2013-06-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 48

Registration Number: NCT00045526

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Erlotinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Mouth or Throat Cancer

Phase 1

Completed

Conditions: Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage II Squamous Cell Carcinoma of the Oropharynx
Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage III Squamous Cell Carcinoma of the Oropharynx
Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage IV Squamous Cell Carcinoma of the Oropharynx

Interventions: Drug: erlotinib hydrochloride
Radiation: intensity-modulated radiation therapy
Drug: cisplatin
Other: laboratory biomarker analysis

First Posted Date: 2003-01-27

Last Posted Date: 2013-09-30

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 48

Registration Number: NCT00049166

Locations: 🇺🇸
Johns Hopkins University, Baltimore, Maryland, United States

Erlotinib and Temozolomide With Radiation Therapy in Treating Patients With Glioblastoma Multiforme or Other Brain Tumors

Phase 2

Completed

Conditions: Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma

Interventions: Drug: erlotinib hydrochloride
Radiation: 3-dimensional conformal radiation therapy
Drug: temozolomide

First Posted Date: 2003-01-27

Last Posted Date: 2013-08-02

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 171

Registration Number: NCT00039494

Locations: 🇺🇸
Graham Hospital Association, Canton, Illinois, United States
🇺🇸
Mcdonough District Hospital, Macomb, Illinois, United States
🇺🇸
Siouxland Regional Cancer Center, Sioux City, Iowa, United States

and more 136 locations

Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma

Phase 1

Completed

Conditions: Adult Giant Cell Glioblastoma
Recurrent Adult Brain Tumor
Adult Anaplastic Oligodendroglioma
Adult Glioblastoma
Adult Gliosarcoma
Adult Grade I Meningioma
Adult Grade III Meningioma
Adult Grade II Meningioma
Adult Anaplastic Astrocytoma

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

First Posted Date: 2003-01-27

Last Posted Date: 2017-08-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 136

Registration Number: NCT00045110

Locations: 🇺🇸
University of California Los Angeles, Los Angeles, California, United States
🇺🇸
University of California San Francisco, San Francisco, California, United States
🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States

and more 4 locations

Erlotinib and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Colorectal Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2013-06-24

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Registration Number: NCT00049101

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

Drug Development Updates

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