Afatinib

Generic Name
Afatinib
Brand Names
Gilotrif, Giotrif
Drug Type
Small Molecule
Chemical Formula
C24H25ClFN5O3
CAS Number
850140-72-6
Unique Ingredient Identifier
41UD74L59M
Background

Afatinib is a 4-anilinoquinazoline tyrosine kinase inhibitor in the form of a dimaleate salt available as Boehringer Ingelheim's brand name Gilotrif . For oral use, afatinib tablets are a first-line (initial) treatment for patients with metastatic non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations as detected by ...

Indication

Afatinib is a kinase inhibitor indicated as monotherapy for the first-line treatment of (a) Epidermal Growth Factor Receptor (EGFR) TKI (tyrosine kinase inhibitor)-naive adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have non-resistant EGFR mutations as detected by an FDA-approved test , and (b) adult pa...

Associated Conditions
Metastatic Non-Small Cell Lung Cancer, Refractory, metastatic squamous cell Non-small cell lung cancer
Associated Therapies
-

Afatinib and Selumetinib in Advanced KRAS Mutant and PIK3CA Wildtype Non-small Cell Lung Cancer

First Posted Date
2015-05-21
Last Posted Date
2018-08-27
Lead Sponsor
The Netherlands Cancer Institute
Target Recruit Count
320
Registration Number
NCT02450656
Locations
🇳🇱

UMC St. Radboud Nijmegen, Nijmegen, Gelderland, Netherlands

🇳🇱

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands

Evaluate the Impact of Afatinib on Quality of Life and Symptom Burden of Greek Subjects With Advanced NSCLC in Routine Patient Care Settings

Completed
Conditions
Interventions
First Posted Date
2015-05-12
Last Posted Date
2022-04-27
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
80
Registration Number
NCT02440854
Locations
🇬🇷

Interbalkan Medical Center of Thessaloniki, Thessaloniki, Greece

🇬🇷

Chest Hospital of Athens "Sotiria", Athens, Greece

🇬🇷

University General Hospital of Heraklion, Heraklion, Greece

and more 4 locations

Safety Study of Afatinib for Brain Cancer

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-04-22
Last Posted Date
2022-03-10
Lead Sponsor
Santosh Kesari
Target Recruit Count
24
Registration Number
NCT02423525
Locations
🇺🇸

John Wayne Cancer Institute, Santa Monica, California, United States

Trial of Afatinib in Pediatric Tumours

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-02-26
Last Posted Date
2021-03-04
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
56
Registration Number
NCT02372006
Locations
🇫🇷

INS Curie, Paris, France

🇦🇺

Sydney Childrens Hospital, Randwick, New South Wales, Australia

🇫🇷

HOP Pellegrin, Bordeaux, France

and more 25 locations

Afatinib in NSCLC With HER2 Mutation

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-02-24
Last Posted Date
2022-08-24
Lead Sponsor
ETOP IBCSG Partners Foundation
Target Recruit Count
13
Registration Number
NCT02369484
Locations
🇨🇭

CHUV, Lausanne, Switzerland

🇨🇭

USZ, Zürich, Switzerland

🇳🇱

NKI-AVL, Amsterdam, Netherlands

and more 2 locations

Afatinib as Second-line Therapy for Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation

Phase 4
Completed
Conditions
Interventions
First Posted Date
2014-08-05
Last Posted Date
2018-12-17
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
60
Registration Number
NCT02208843
Locations
🇷🇴

Sf. Nectarie Oncology Center, Craiova, Craiova, Romania

🇷🇸

Institute for Oncol & Radiol of Serbia, Clinic f. Med. Onco., Belgrade, Serbia

🇹🇭

King Chulalongkorn Memorial Hospital, Bangkok, Thailand

and more 18 locations

Xentuzumab (BI 836845) Plus Afatinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

First Posted Date
2014-07-16
Last Posted Date
2018-05-01
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
32
Registration Number
NCT02191891
Locations
🇰🇷

Asan Medical Center, Seoul, Korea, Republic of

🇯🇵

National Hospital Organization Kyushu Cancer Center, Fukuoka, Fukuoka, Japan

🇸🇬

National Cancer Centre, Singapore, Singapore

and more 7 locations

Deciphering Afatinib Response and Resistance With INtratumour Heterogeneity

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-07-08
Last Posted Date
2023-11-29
Lead Sponsor
University College, London
Target Recruit Count
12
Registration Number
NCT02183883
Locations
🇬🇧

Beatson West of Scotland Cancer Centre (NHS Greater Glasgow & Clyde), Glasgow, United Kingdom

🇬🇧

Aberdeen Royal Infirmary (NHS Grampian), Aberdeen, United Kingdom

🇬🇧

Heart of England NHS Foundation Trust, Birmingham, United Kingdom

and more 4 locations

LUX-Head & Neck 4: Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

Phase 3
Terminated
Conditions
Interventions
First Posted Date
2014-05-06
Last Posted Date
2019-03-01
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
36
Registration Number
NCT02131155
Locations
🇨🇳

1200.162.86013 Boehringer Ingelheim Investigational Site, Jinan, China

🇨🇳

1200.162.86007 Boehringer Ingelheim Investigational Site, Chengdu, China

🇰🇷

1200.162.82001 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of

and more 13 locations
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