Gefitinib

Generic Name: Gefitinib

Brand Names: Iressa, Gefitinib Mylan

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₄ClFN_₄O_₃

CAS Number: 184475-35-2

Unique Ingredient Identifier: S65743JHBS

Background: Gefitinib (originally coded ZD1839) is a drug used in the treatment of certain types of cancer. Acting in a similar manner to erlotinib (marketed as Tarceva), gefitinib selectively targets the mutant proteins in malignant cells. It is marketed by AstraZeneca under the trade name Iressa.

Indication: For the continued treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of either platinum-based or docetaxel chemotherapies.

Associated Conditions: Metastatic Non-Small Cell Lung Cancer

Associated Therapies: -

Clinical Trials

Postoperative Radiotherapy Plus Iressa or Radiotherapy Plus Cisplatin and Iressa for Advanced Head & Neck Cancer

Phase 1

Completed

Conditions: Head and Neck Cancer

Interventions: Drug: Gefitinib

First Posted Date: 2008-05-21

Last Posted Date: 2010-09-23

Lead Sponsor: AstraZeneca

Target Recruit Count: 30

Registration Number: NCT00681967

Locations: 🇨🇭
Research Site, Bern, Switzerland

Ph II Early BC Pre-Surgical Biologic Study

Phase 2

Completed

Conditions: Breast Cancer

First Posted Date: 2008-03-17

Last Posted Date: 2009-04-23

Lead Sponsor: AstraZeneca

Target Recruit Count: 65

Registration Number: NCT00637026

Open Label Trial to Assess Iressa in Prostate Cancer Patients

Phase 2

Completed

Conditions: Prostate Cancer

First Posted Date: 2008-03-14

Last Posted Date: 2009-04-23

Lead Sponsor: AstraZeneca

Target Recruit Count: 100

Registration Number: NCT00635856

Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

Phase 2

Conditions: Lung Cancer

First Posted Date: 2008-02-15

Last Posted Date: 2009-02-09

Lead Sponsor: Yonsei University

Target Recruit Count: 35

Registration Number: NCT00616499

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of
🇰🇷
Yonsei Cancer Center at Yonsei University Medical Center, Seoul, Korea, Republic of
🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

and more 1 locations

Efficacy of Gefitinib for Brain Metastasis of Non-Small Cell Lung Cancer

Phase 2

Conditions: Non-Small Cell Lung Cancer
Brain Metastasis

Interventions: Drug: gefitinib

First Posted Date: 2008-02-13

Last Posted Date: 2008-02-22

Lead Sponsor: Guangdong Provincial People's Hospital

Target Recruit Count: 45

Registration Number: NCT00614809

SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients

Phase 4

Completed

Conditions: Non Small Cell Lung Carcinoma

First Posted Date: 2008-02-06

Last Posted Date: 2012-09-28

Lead Sponsor: AstraZeneca

Target Recruit Count: 156

Registration Number: NCT00608868

Locations: 🇰🇷
Research Site, Daegu, Korea, Republic of

Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene

Phase 2

Completed

Conditions: Lung Cancer
Non-small Cell Lung Cancer
Bronchioloalveolar Cancer

Interventions: Drug: Gefitinib

First Posted Date: 2008-01-08

Last Posted Date: 2016-01-22

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 65

Registration Number: NCT00588445

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

Study to Assess Safety/Tolerability/Efficacy of Gefitinib Versus Docetaxel in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Phase 4

Terminated

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Gefitinib
Procedure: CT or MRI
Drug: Docetaxel

First Posted Date: 2007-09-27

Last Posted Date: 2013-10-01

Lead Sponsor: AstraZeneca

Target Recruit Count: 14

Registration Number: NCT00536107

Locations: 🇨🇳
Research Site, Taipei, Taiwan

Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) in Squamous Cell Carcinoma of the Head and Neck

Phase 2

Completed

Conditions: Head and Neck Neoplasms

Interventions: Drug: Gefitinib

First Posted Date: 2007-08-21

Last Posted Date: 2016-07-01

Lead Sponsor: University of Chicago

Target Recruit Count: 44

Registration Number: NCT00519077

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States

Iressa Study in Patients With Salivary Gland Cancer

Phase 2

Completed

Conditions: Salivary Gland Cancer

Interventions: Drug: Gefitinib

First Posted Date: 2007-07-30

Last Posted Date: 2017-11-24

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 37

Registration Number: NCT00509002

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Drug Development Updates

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