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

Associated Therapies: -

Clinical Trials

Evaluating Efficacy and Safety of Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Chemotherapy

Conditions: Non-small Cell Lung Cancer

First Posted Date: 2011-02-16

Last Posted Date: 2011-02-16

Lead Sponsor: Shanghai Chest Hospital

Registration Number: NCT01297101

A Safety Study in Participants With Advanced Solid Tumors

Phase 1

Terminated

Conditions: Advanced Solid Tumors

Interventions: Drug: Temozolomide
Drug: Gemcitabine
Drug: Docetaxel
Drug: Cisplatin
Drug: Erlotinib
Drug: LY573636

First Posted Date: 2011-01-27

Last Posted Date: 2019-01-10

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 234

Registration Number: NCT01284335

Locations: 🇺🇸
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Yakima, Washington, United States

A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

Phase 2

Completed

Conditions: Non-Squamous Non-Small Cell Lung Cancer

Interventions: Drug: Erlotinib

First Posted Date: 2010-12-15

Last Posted Date: 2018-10-31

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 30

Registration Number: NCT01260181

Locations: 🇵🇹
Hospital Geral; Servico de Pneumologia, Coimbra, Portugal
🇵🇹
IPO de Lisboa; Servico de Pneumologia, Lisboa, Portugal
🇵🇹
Hospital de Santa Maria; Servico de Pneumologia, Lisboa, Portugal

and more 6 locations

EGFR Inhibition Using Weekly Erlotinib for Recurrent Malignant Gliomas

Phase 1

Completed

Conditions: Brain Cancer

Interventions: Drug: erlotinib
Procedure: Cytoreductive Surgery

First Posted Date: 2010-12-09

Last Posted Date: 2023-05-25

Lead Sponsor: Andrew B Lassman, MD

Target Recruit Count: 22

Registration Number: NCT01257594

Locations: 🇺🇸
Columbia University Irving Medical Center, New York, New York, United States
🇺🇸
Memorial Sloan-Kettering at Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center at Commack, Commack, New York, United States

and more 1 locations

BATTLE-2 Program: A Biomarker-Integrated Targeted Therapy Study in Previously Treated Patients With Advanced Non-Small Cell Lung Cancer

Phase 2

Completed

Conditions: Lung Cancer

Interventions: Drug: AZD6244
Drug: Erlotinib
Drug: Sorafenib
Drug: MK-2206

First Posted Date: 2010-11-25

Last Posted Date: 2022-01-12

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 334

Registration Number: NCT01248247

Locations: 🇺🇸
Yale Universtiy, New Haven, Connecticut, United States
🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205

Phase 2

Terminated

Conditions: Ependymoma

Interventions: Drug: Erlotinib

First Posted Date: 2010-11-25

Last Posted Date: 2024-12-06

Lead Sponsor: OSI Pharmaceuticals

Target Recruit Count: 4

Registration Number: NCT01247922

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
Packard Children's Hospital, Palo Alto, California, United States
🇺🇸
Children's Hospital of Orange County (CHOC), Orange, California, United States

and more 18 locations

Tivantinib Plus Erlotinib Versus Placebo Plus Erlotinib for the Treatment of Non-squamous, Non-small-cell Lung Cancer

Phase 3

Terminated

Conditions: Non Squamous, Non-small-cell Lung Cancer

Interventions: Drug: Placebo
Drug: Tivantinib
Drug: Erlotinib

First Posted Date: 2010-11-19

Last Posted Date: 2021-04-06

Lead Sponsor: Daiichi Sankyo

Target Recruit Count: 1048

Registration Number: NCT01244191

A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression

Phase 4

Completed

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Erlotinib

First Posted Date: 2010-10-29

Last Posted Date: 2015-03-30

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 51

Registration Number: NCT01230710

Randomized Phase II Study of AZD6244 (Mitogen-activated Protein Kinase Inhibitor) MEK-Inhibitor With Erlotinib in KRAS Wild Type Advanced Non-Small Cell Lung Cancer (NSCLC) and a Randomized Phase II Study of AZD6244 With Erlotinib in Mutant KRAS Adva...

Phase 2

Completed

Conditions: Non Small Cell Lung Carcinoma

Interventions: Drug: AZD6244 + Erlotinib
Drug: AZD6244
Drug: Erlotinib

First Posted Date: 2010-10-27

Last Posted Date: 2017-05-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 89

Registration Number: NCT01229150

Locations: 🇺🇸
University of Southern California Health Sciences Campus, Los Angeles, California, United States
🇺🇸
City of Hope Medical Group, South Pasadena, California, United States
🇺🇸
University of Chicago Medical Center, Chicago, Illinois, United States

and more 2 locations

Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene

Phase 2

Completed

Conditions: NSCLC
Non Small Cell Lung Cancer

Interventions: Drug: Erlotinib
Drug: OSI-906
Drug: Placebo

First Posted Date: 2010-10-14

Last Posted Date: 2024-11-20

Lead Sponsor: Astellas Pharma Inc

Target Recruit Count: 88

Registration Number: NCT01221077

Locations: 🇺🇸
Northwestern Memorial Hospital, Chicago, Illinois, United States
🇺🇸
Medical University of South Carolina, Charleston, South Carolina, United States
🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

and more 26 locations

Drug Development Updates

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