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
-

Clinical Study for the Treatment of Breast Cancer: the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone

Phase 2
Terminated
Conditions
Interventions
First Posted Date
2014-04-15
Last Posted Date
2019-12-26
Lead Sponsor
Translational Research in Oncology
Target Recruit Count
44
Registration Number
NCT02115048
Locations
🇧🇦

University Hospital Clinical Center Banja Luka, Oncology Clinic, Banja Luka, Bosnia and Herzegovina

🇺🇸

DBA Torrance Memorial Physician Network/Cancer Care Associates, Redondo Beach, California, United States

🇪🇸

Hospital Clínico Universitario Virgen de La Arrixaca, Murcia, Spain

and more 23 locations

GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations

Completed
Conditions
Interventions
First Posted Date
2014-01-28
Last Posted Date
2020-01-09
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
161
Registration Number
NCT02047903

Afatinib in Patients With Non Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations

Phase 3
Completed
Conditions
Interventions
First Posted Date
2014-01-24
Last Posted Date
2017-03-31
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
14
Registration Number
NCT02044380
Locations
🇨🇦

Boehringer Ingelheim Investigational Site, Montreal, Quebec, Canada

Trial of Afatinib (BIBW 2992) + Cetuximab in Advanced Solid Tumours

Phase 1
Completed
Conditions
Interventions
First Posted Date
2013-12-25
Last Posted Date
2017-06-22
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
58
Registration Number
NCT02020577
Locations
🇫🇷

1200.122.33001 Boehringer Ingelheim Investigational Site, Villejuif Cedex, France

🇪🇸

1200.122.34001 Boehringer Ingelheim Investigational Site, Madrid, Spain

Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-10-01
Last Posted Date
2019-08-12
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
542
Registration Number
NCT01953913
Locations
🇨🇳

Zhejiang Cancer Hospital, Hangzhou, China

🇨🇳

Shanghai Chest Hospital, Shanghai, China

🇨🇳

Shanghai Pulmonary Hospital, Shanghai, China

and more 30 locations

Expanded Access Study of Afatinib in Treatment-naive or Chemotherapy Pre-treated Patients With Non-small Cell Lung Cancer (NSCLC)

First Posted Date
2013-08-29
Last Posted Date
2018-11-14
Lead Sponsor
Boehringer Ingelheim
Registration Number
NCT01931306
Locations
🇰🇷

The Catholic University of Korea, Bucheon St.Mary's Hospital, Bucheon, Korea, Republic of

🇰🇷

Chonnam National University Hwasun Hospital, Jeonnam, Korea, Republic of

🇰🇷

Gachon University Gil Medical Center, Incheon, Korea, Republic of

and more 5 locations

LUX-Head&Neck 3: Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2013-05-17
Last Posted Date
2024-10-31
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
340
Registration Number
NCT01856478
Locations
🇨🇳

Harbin Medical University Cancer Hospital, Harbin, China

🇨🇳

Beijing Chao-Yang Hospital, Beijing, China

🇨🇳

Cancer Hospital of Chinese Academy of Medical Science, Beijing, China

and more 49 locations

An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)

Phase 3
Completed
Conditions
Interventions
First Posted Date
2013-05-15
Last Posted Date
2024-03-26
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
481
Registration Number
NCT01853826
Locations
🇮🇹

A.O. Univ. Policlinico "Paolo Giaccone", Palermo, Italy

🇨🇿

University Hospital Ostrava, Ostrava, Czechia

🇮🇱

Rabin Medical Center Beilinson, Petah Tikva, Israel

and more 115 locations

Afatinib After Chemoradiation and Surgery in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck at High-Risk of Recurrence

First Posted Date
2013-04-05
Last Posted Date
2023-06-28
Lead Sponsor
ECOG-ACRIN Cancer Research Group
Target Recruit Count
3
Registration Number
NCT01824823
Locations
🇺🇸

John H Stroger Jr Hospital of Cook County, Chicago, Illinois, United States

🇺🇸

University of Illinois, Chicago, Illinois, United States

🇺🇸

Bozeman Deaconess Hospital, Bozeman, Montana, United States

and more 269 locations
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