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 Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors

Phase 1

Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Pancreatic Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2018-01-10

Lead Sponsor: OSI Pharmaceuticals

Registration Number: NCT00033241

Locations: 🇺🇸
Arizona Cancer Center at University of Arizona Health Sciences Center, Tucson, Arizona, United States
🇺🇸
Cancer Therapy and Research Center, San Antonio, Texas, United States

Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer

Phase 2

Completed

Conditions: Endometrial Cancer

First Posted Date: 2003-01-27

Last Posted Date: 2014-01-27

Lead Sponsor: National Cancer Institute (NCI)

Registration Number: NCT00030485

Locations: 🇨🇦
Princess Margaret Hospital, Toronto, Ontario, Canada
🇨🇦
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, Canada
🇨🇦
British Columbia Cancer Agency, Vancouver, British Columbia, Canada

and more 5 locations

Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Adenocarcinoma of the Rectum
Recurrent Rectal Cancer
Stage IV Rectal Cancer
Adenocarcinoma of the Colon
Stage IV Colon Cancer
Recurrent Colon Cancer

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

First Posted Date: 2003-01-27

Last Posted Date: 2015-04-15

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 30

Registration Number: NCT00032110

Locations: 🇨🇦
Princess Margaret Hospital Phase 2 Consortium, Toronto, Ontario, Canada

Safety, Efficacy, and Pharmacokinetics Study of Tarceva to Treat Advanced Colorectal Cancer

Phase 1

Completed

Conditions: Colorectal Cancer

First Posted Date: 2002-10-18

Last Posted Date: 2005-06-24

Lead Sponsor: Genentech, Inc.

Registration Number: NCT00047762

Locations: 🇺🇸
Johns Hopkins Oncology Center, Baltimore, Maryland, United States
🇺🇸
Indiana University Cancer Pavilion, Indianapolis, Indiana, United States
🇺🇸
Mary Crowley Medical Research Center, Dallas, Texas, United States

A Study With Tarceva and Chemotherapy vs. Chemotherapy Alone in Patients With Advanced Lung Cancer

Phase 3

Completed

Conditions: Lung Cancer

First Posted Date: 2002-10-17

Last Posted Date: 2013-06-21

Lead Sponsor: Genentech, Inc.

Registration Number: NCT00047736

Locations: 🇺🇸
Multinational Sites, Denver, Colorado, United States
🇺🇸
Trial Information Center, Denver, Colorado, United States

Avastin and Tarceva for Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer

Phase 1

Completed

Conditions: Lung Cancer

Interventions: Drug: Avastin
Drug: Tarceva

First Posted Date: 2002-08-15

Last Posted Date: 2018-11-07

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 41

Registration Number: NCT00043823

Locations: 🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
🇺🇸
University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States

OSI-774 (Tarceva) Plus Gemcitabine in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer.

Phase 3

Completed

Conditions: Pancreatic Cancer

First Posted Date: 2002-06-25

Last Posted Date: 2018-01-10

Lead Sponsor: OSI Pharmaceuticals

Target Recruit Count: 569

Registration Number: NCT00040183

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇨🇦
Kingston Regional Cancer Centre, Kingston, Ontario, Canada
🇺🇸
Florida Cancer Specialists, Fort Myers, Florida, United States

and more 137 locations

OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

Phase 3

Completed

Conditions: Carcinoma, Non-small-cell Lung

First Posted Date: 2002-05-14

Last Posted Date: 2018-01-10

Lead Sponsor: OSI Pharmaceuticals

Target Recruit Count: 731

Registration Number: NCT00036647

Locations: 🇧🇷
Instituto do Cancer do Ceara, Fortaleza, CEP, Brazil
🇧🇷
Instituto do Cancer Arnaldo Vieira de Carvalho, Sao Paulo, SP, Brazil
🇲🇽
Instituto Nacional de Cancerologia, Mexico City, CP, Mexico

and more 93 locations

Drug Development Updates

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