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
-

Phase II Study of Afatinib as Third- or Further-line Treatment for Patients With Stage IV Bronchial Adenocarcinoma, Harboring Wild-type EGFR, Expressing the Neurotensin - Neurotensin Receptor Complex

Phase 2
Withdrawn
Conditions
First Posted Date
2016-08-23
Last Posted Date
2017-09-11
Lead Sponsor
Fondation Hôpital Saint-Joseph
Registration Number
NCT02876081
Locations
🇫🇷

Groupe Hospitalier Paris Saint Joseph, Paris, Ile-de-France, France

Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations

First Posted Date
2016-06-09
Last Posted Date
2023-12-05
Lead Sponsor
SCRI Development Innovations, LLC
Target Recruit Count
100
Registration Number
NCT02795156
Locations
🇺🇸

Medical College of Wisconsin, Milwaukee, Wisconsin, United States

🇺🇸

Florida Cancer Specialists - South, Fort Myers, Florida, United States

🇺🇸

Florida Cancer Specialists - East, West Palm Beach, Florida, United States

and more 5 locations

Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy

Phase 2
Completed
Conditions
Interventions
First Posted Date
2016-05-23
Last Posted Date
2020-11-18
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
42
Registration Number
NCT02780687
Locations
🇮🇹

A.O. San Camillo Forlanini, Roma, Italy

🇫🇷

HOP Foch, Suresnes, France

🇫🇷

INS Bergonié, Bordeaux, France

and more 27 locations

Cambridge Brain Mets Trial 1

First Posted Date
2016-05-11
Last Posted Date
2024-01-31
Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust
Target Recruit Count
26
Registration Number
NCT02768337
Locations
🇬🇧

The Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom

🇬🇧

Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom

🇬🇧

Clatterbridge Cancer Centre, Liverpool, United Kingdom

and more 3 locations

Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

Phase 2
Completed
Conditions
Interventions
First Posted Date
2016-04-22
Last Posted Date
2021-03-19
Lead Sponsor
Samsung Medical Center
Target Recruit Count
50
Registration Number
NCT02747953

Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer

Phase 2
Completed
Conditions
Interventions
First Posted Date
2016-03-23
Last Posted Date
2022-08-11
Lead Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Target Recruit Count
118
Registration Number
NCT02716311
Locations
🇫🇷

Clinique de L'Europe, Amiens, France

🇫🇷

Centre Hospitalier du Pays d'Aix, Aix-en-Provence, France

🇫🇷

Annecy - CH, Annecy, France

and more 30 locations

Afatinib in EGFR+NSCLC (Recurrent or Stage IV) - Patients With Poor Performance Status (ECOG 2 or 3)

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2016-03-01
Last Posted Date
2017-09-18
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
1
Registration Number
NCT02695290
Locations
🇺🇸

1200.208.10032 Boehringer Ingelheim Investigational Site, Fountain Valley, California, United States

Afatinib in Lung Cancer With EGFR Mutation From Circulating Tumor DNA

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-12-14
Last Posted Date
2021-08-03
Lead Sponsor
Chonnam National University Hospital
Target Recruit Count
21
Registration Number
NCT02629523
Locations
🇰🇷

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

Afatinib vs Erlotinib as 2nd TKI After Failure to 1st TKI and Chemotherapy for Metastatic NSCLC

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-12-09
Last Posted Date
2015-12-09
Lead Sponsor
The University of Hong Kong
Target Recruit Count
25
Registration Number
NCT02625168
Locations
🇭🇰

Department of Clinical Oncology, Queen Mary Hospital, Hong Kong, Hong Kong

Afatinib in NSCLC With HER2 Mutation

First Posted Date
2015-11-05
Last Posted Date
2019-10-01
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
18
Registration Number
NCT02597946
Locations
🇨🇳

First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China

🇨🇳

Zhejiang Cancer Hospital, Hangzhou, China

🇨🇳

The Second Affiliated Hospital to Nanchang University, Nanchang, China

and more 6 locations
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