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
- -
ADAM-Afatinib Diarrhea Assessment and Management
- First Posted Date
- 2013-03-20
- Last Posted Date
- 2016-10-31
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 40
- Registration Number
- NCT01814553
- Locations
- 🇺🇸
1200.167.01001 Boehringer Ingelheim Investigational Site, Morristown, New Jersey, United States
🇺🇸1200.167.01009 Boehringer Ingelheim Investigational Site, Santa Rosa, California, United States
🇺🇸1200.167.01020 Boehringer Ingelheim Investigational Site, Orlando, Florida, United States
Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer
- Conditions
- Interventions
- First Posted Date
- 2013-02-05
- Last Posted Date
- 2024-03-06
- Lead Sponsor
- Dana-Farber Cancer Institute
- Target Recruit Count
- 38
- Registration Number
- NCT01783587
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Mount Sinai Medical Center/Icahn School of Medicine at Mount Sinai, New York, New York, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Adjuvant Afatinib in Stage I-III NSCLC With EGFR Mutation
- First Posted Date
- 2012-12-10
- Last Posted Date
- 2020-07-07
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 92
- Registration Number
- NCT01746251
- Locations
- 🇺🇸
Stanford University, Palo Alto, California, United States
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
A Phase I/II Study Afatinib/Carboplatin/Paclitaxel Induction Chemotherapy In HPV-Negative HNSCC.
- Conditions
- Interventions
- First Posted Date
- 2012-11-26
- Last Posted Date
- 2018-07-26
- Target Recruit Count
- 9
- Registration Number
- NCT01732640
- Locations
- 🇺🇸
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
🇺🇸Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
Afatinib as Cancer Therapy for Exocrine Pancreatic Tumours
- First Posted Date
- 2012-11-20
- Last Posted Date
- 2017-07-19
- Lead Sponsor
- PD Dr. med. Volker Heinemann
- Target Recruit Count
- 119
- Registration Number
- NCT01728818
- Locations
- 🇩🇪
University of Munich, Munich, Germany
Afatinib Expanded Access Program
- Conditions
- First Posted Date
- 2012-07-25
- Last Posted Date
- 2016-11-30
- Lead Sponsor
- Boehringer Ingelheim
- Registration Number
- NCT01649284
- Locations
- 🇺🇸
1200.45.004 Boehringer Ingelheim Investigational Site, Mobile, Alabama, United States
🇺🇸1200.45.116 Boehringer Ingelheim Investigational Site, Goodyear, Arizona, United States
🇺🇸1200.45.078 Boehringer Ingelheim Investigational Site, Anaheim, California, United States
Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer.
- Conditions
- Interventions
- First Posted Date
- 2012-07-25
- Last Posted Date
- 2017-12-22
- Lead Sponsor
- Boehringer Ingelheim
- Target Recruit Count
- 13
- Registration Number
- NCT01649271
- Locations
- 🇫🇷
CTR Georges-François Leclerc, Dijon, France
🇫🇷INS Claudius Regaud, Toulouse, France
🇫🇷CTR René Gauducheau, Onco, St Herblain, Saint Herblain Cedex, France
Dual Blockage With Afatinib and Trastuzumab as Neoadjuvant Treatment for Patients With Locally Advanced or Operable Breast Cancer Receiving Taxane-anthracycline Containing Chemotherapy
- Conditions
- Interventions
- First Posted Date
- 2012-05-08
- Last Posted Date
- 2014-03-13
- Lead Sponsor
- German Breast Group
- Target Recruit Count
- 65
- Registration Number
- NCT01594177
- Locations
- 🇩🇪
Rotkreuzklinikum München, München, Germany
Afatinib With CT and RT for EGFR-Mutant NSCLC
- Conditions
- Interventions
- First Posted Date
- 2012-03-14
- Last Posted Date
- 2024-11-20
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 19
- Registration Number
- NCT01553942
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
Neoadjuvant Afatinib Window Study in Squamous Cell Carcinoma of the Head and Neck
- Conditions
- Interventions
- First Posted Date
- 2012-02-24
- Last Posted Date
- 2018-07-09
- Target Recruit Count
- 30
- Registration Number
- NCT01538381
- Locations
- 🇮🇹
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori, Milano, Italy
🇧🇪Institut Jules Bordet, Brussels, Belgium
🇧🇪Cliniques Universitaires St. Luc, Brussels, Belgium
Drug Development Updates
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