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

Clinical Trials

A Study of ASP8273 vs. Erlotinib or Gefitinib in First-line Treatment of Patients With Stage IIIB/IV Non-small Cell Lung Cancer Tumors With EGFR Activating Mutations

Phase 3

Terminated

Conditions: Non-small Cell Lung Cancer (NSCLC)

Interventions: Drug: naquotinib mesilate
Drug: Erlotinib
Drug: Gefitinib

First Posted Date: 2015-10-27

Last Posted Date: 2024-12-10

Lead Sponsor: Astellas Pharma Global Development, Inc.

Target Recruit Count: 530

Registration Number: NCT02588261

Locations: 🇺🇸
Site US10025, Fountain Valley, California, United States
🇺🇸
Site US10003, Santa Monica, California, United States
🇺🇸
Site US10013, Aventura, Florida, United States

and more 164 locations

Pemetrexed Combined With Synchronous Gefitinib as Adjuvent Therapy in Patient With EGFR Mutant Lung Adenocarcinoma

Phase 3

Conditions: Lung Neoplasms

Interventions: Drug: Gefitinib
Drug: Pemetrexed

First Posted Date: 2015-08-10

Last Posted Date: 2015-08-10

Lead Sponsor: Tang-Du Hospital

Target Recruit Count: 220

Registration Number: NCT02518802

Locations: 🇨🇳
Tangdu Hospital of the Fourth Millitary Medical University, Xi'an, Shaanxi, China

Targeted Therapy With Gefitinib in Patients With USP8-mutated Cushing's Disease

Phase 2

Conditions: Cushing's Disease
Corticotrophin Adenoma

Interventions: Drug: Gefitinib

First Posted Date: 2015-06-30

Last Posted Date: 2015-06-30

Lead Sponsor: Huashan Hospital

Target Recruit Count: 6

Registration Number: NCT02484755

Locations: 🇨🇳
Huashan Hospital, Shanghai, Shanghai, China

Study to Evaluate the Safety and Efficacy of Gefitinib, in Subjects With EFGR Amplification Refractory Solid Tumors

Phase 2

Completed

Conditions: Solid Tumor

Interventions: Drug: Gefitinib

First Posted Date: 2015-05-18

Last Posted Date: 2022-06-15

Lead Sponsor: Samsung Medical Center

Target Recruit Count: 16

Registration Number: NCT02447419

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

Phase 3

Active, not recruiting

Conditions: Metastatic Non-Small Cell Lung Cancer

Interventions: Drug: Placebo
Drug: Ramucirumab
Drug: Erlotinib
Drug: Gefitinib
Drug: Osimertinib

First Posted Date: 2015-04-08

Last Posted Date: 2025-04-20

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 545

Registration Number: NCT02411448

Locations: 🇺🇸
UCLA Hematology/Oncology - Santa Monica, Los Angeles, California, United States
🇺🇸
AHN Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
🇯🇵
Hyogo Prefectual Amagasaki General Medical Center, Amagashiki, Hyogo, Japan

and more 103 locations

Gefitinib Combined With Thalidomide to Treat NSCLC

Phase 2

Conditions: NSCLC

Interventions: Drug: placebo
Drug: Thalidomide
Drug: Gefitinib
Drug: Aspirin

First Posted Date: 2015-03-12

Last Posted Date: 2015-03-12

Lead Sponsor: Bai Jun

Target Recruit Count: 380

Registration Number: NCT02387086

A Phase I Study of Safety and Pharmacokinetics of Volitinib in Combination With Gefitinib in EGFR(+) NSCLC

Phase 1

Completed

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Volitinib
Drug: gefitinib

First Posted Date: 2015-03-02

Last Posted Date: 2020-04-24

Lead Sponsor: Hutchison Medipharma Limited

Target Recruit Count: 64

Registration Number: NCT02374645

Locations: 🇨🇳
Guangdong General Hospital, Guangzhou, China

Comparator-Controlled Study for EGFR(+) Patients With Multiple BMs From NSCLC (BROKE) (EGFR-epidermal Growth Factor Receptor;BM-brain Metastases)

Phase 2

Conditions: Brain Metastases
Non-Small Cell Lung Cancer
EGFR Gene Mutation

Interventions: Drug: Gefitinib
Radiation: WBRT

First Posted Date: 2015-01-14

Last Posted Date: 2015-01-26

Lead Sponsor: Shanghai Chest Hospital

Target Recruit Count: 210

Registration Number: NCT02338011

Locations: 🇨🇳
Varian linear accelerato, Shanghai, Shanghai, China

Induction Therapy With Intercalated Tyrosine Kinase Inhibitor (TKI) and Chemotherapy in NSCLC With Activating Epidermal Growth Factor Receptor (EGFR) Mutation in Stages II-IIIB

Phase 2

Terminated

Conditions: Activating EGFR Mutation
Non-squamous Non-small Cell Lung Cancer Stage IIIA
Non-squamous Non-small Cell Lung Cancer Stage IIIB
NSCLC
Non-squamous Non-small Cell Lung Cancer Stage II

Interventions: Drug: Gefitinib
Drug: docetaxel
Drug: cisplatin
Procedure: Surgery

First Posted Date: 2014-12-29

Last Posted Date: 2018-01-23

Lead Sponsor: AIO-Studien-gGmbH

Target Recruit Count: 1

Registration Number: NCT02326285

Locations: 🇩🇪
Pius-Hospital, Oldenburg, Germany

GEfitinib Plus viNOrelbine in Advanced EGFR Mutated NSCLC. GENOA Trial

Phase 2

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: oral vinorelbine
Drug: Gefitinib

First Posted Date: 2014-12-18

Last Posted Date: 2014-12-18

Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Target Recruit Count: 80

Registration Number: NCT02319577

Locations: 🇮🇹
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy

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