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

Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: gefitinib
Drug: tamoxifen citrate
Drug: Placebo

First Posted Date: 2004-04-08

Last Posted Date: 2009-08-06

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Target Recruit Count: 2

Registration Number: NCT00080743

Locations: 🇺🇸
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

ZD 1839 in Treating Patients With Metastatic Kidney Cancer

Phase 2

Completed

Conditions: Kidney Cancer

First Posted Date: 2004-03-17

Last Posted Date: 2013-06-24

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Registration Number: NCT00012337

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

Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Anastrozole
Drug: Gefitinib

First Posted Date: 2004-02-11

Last Posted Date: 2014-07-16

Lead Sponsor: AstraZeneca

Target Recruit Count: 174

Registration Number: NCT00077025

Locations: 🇻🇪
Research Site, Valencia, Venezuela

Iressa Versus Docetaxel (Taxotere)

Phase 3

Completed

Conditions: Non-Small-Cell Lung Carcinoma

First Posted Date: 2004-01-23

Last Posted Date: 2011-05-13

Lead Sponsor: AstraZeneca

Target Recruit Count: 1440

Registration Number: NCT00076388

Locations: 🇹🇷
Research Site, Izmir, Turkey
🇦🇷
Research site, El Palomar, Argentina

Gefitinib in Treating Patients With Progressive Metastatic Neuroendocrine Tumors

Phase 2

Completed

Conditions: Gastrinoma
Glucagonoma
Insulinoma
Metastatic Gastrointestinal Carcinoid Tumor
Pancreatic Polypeptide Tumor
Recurrent Gastrointestinal Carcinoid Tumor
Recurrent Islet Cell Carcinoma
Somatostatinoma
WDHA Syndrome

Interventions: Drug: gefitinib
Other: laboratory biomarker analysis

First Posted Date: 2004-01-12

Last Posted Date: 2013-06-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 90

Registration Number: NCT00075439

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

ZD 1839 in Treating Patients With Stage IV or Recurrent Kidney Cancer

Phase 2

Completed

Conditions: Kidney Cancer

First Posted Date: 2004-01-01

Last Posted Date: 2019-11-07

Lead Sponsor: University of Maryland, Baltimore

Registration Number: NCT00014183

Locations: 🇺🇸
Veterans Affairs Medical Center - Baltimore, Baltimore, Maryland, United States
🇺🇸
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States

Gefitinib in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)

Phase 2

Completed

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

Interventions: Drug: gefitinib
Other: laboratory biomarker analysis

First Posted Date: 2003-11-06

Last Posted Date: 2013-02-27

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 59

Registration Number: NCT00071994

Locations: 🇺🇸
Eastern Cooperative Oncology Group, Boston, Massachusetts, United States

Gefitinib in Treating Patients With Recurrent Metastatic Colorectal Cancer

Phase 2

Completed

Conditions: Colorectal Cancer

First Posted Date: 2003-10-22

Last Posted Date: 2013-06-24

Lead Sponsor: Eastern Cooperative Oncology Group

Registration Number: NCT00025350

Locations: 🇺🇸
CCOP - Evanston, Evanston, Illinois, United States
🇺🇸
CCOP - Kalamazoo, Kalamazoo, Michigan, United States
🇺🇸
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States

and more 13 locations

Gefitinib in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Phase 2

Completed

Conditions: Ovarian Cancer
Primary Peritoneal Cavity Cancer

First Posted Date: 2003-10-15

Last Posted Date: 2013-06-24

Lead Sponsor: Gynecologic Oncology Group

Registration Number: NCT00023699

Locations: 🇺🇸
Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States
🇺🇸
Rush-Presbyterian-St. Luke's Medical Center, Chicago, Illinois, United States
🇺🇸
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States

and more 50 locations

S0031, ZD 1839 in Treating Patients With Advanced Cancer of the Urinary Tract

Phase 2

Completed

Conditions: Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer

Interventions: Drug: gefitinib

First Posted Date: 2003-10-15

Last Posted Date: 2012-10-08

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 31

Registration Number: NCT00014144

Locations: 🇺🇸
MBCCOP - Gulf Coast, Mobile, Alabama, United States
🇺🇸
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, United States
🇺🇸
CCOP - Atlanta Regional, Atlanta, Georgia, United States

and more 92 locations

Drug Development Updates

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