Afatinib

Generic Name: Afatinib

Brand Names: Gilotrif, Giotrif

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₅ClFN_₅O_₃

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 an FDA-approved test . Gilotrif (afatinib) is the first FDA-approved oncology product from Boehringer Ingelheim .

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 patients with locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy .

Recently, as of January 2018, the US FDA approved a supplemental New Drug Application for Boehringer Ingelheim's Gilotrif (afatinib) for the first line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test . The new label includes data on three additional EGFR mutations: L861Q, G719X and S768I .

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

Associated Therapies: -

Clinical Trials

Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation

Phase 1

Withdrawn

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: Afatinib
Drug: Cisplatin
Drug: Carboplatin
Drug: Pemetrexed
Radiation: Radiation therapy

First Posted Date: 2013-04-19

Last Posted Date: 2013-12-19

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Registration Number: NCT01836341

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

Phase 2

Terminated

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Other: placebo
Drug: afatinib

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

ADAM-Afatinib Diarrhea Assessment and Management

Phase 3

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: afatinib
Drug: loperamide

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

and more 9 locations

Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer

Phase 1

Completed

Conditions: Squamous Cell Carcinoma of the Head and Neck

Interventions: Drug: Afatinib
Radiation: Radiation Therapy
Drug: Docetaxel

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

Phase 2

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Afatinib

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

and more 1 locations

A Phase I/II Study Afatinib/Carboplatin/Paclitaxel Induction Chemotherapy In HPV-Negative HNSCC.

Phase 1

Terminated

Conditions: Squamous Cell Carcinoma of the Head and Neck

Interventions: Drug: Afatinib
Drug: Paclitaxel
Drug: Carboplatin
Drug: Cisplatin
Radiation: Intensity Modulated Radiation Therapy

First Posted Date: 2012-11-26

Last Posted Date: 2018-07-26

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Phase 2

Conditions: Focus of Study Instead

Interventions: Drug: Gemcitabine
Drug: Afatinib

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: Carcinoma, Non-Small-Cell Lung

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

and more 63 locations

Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer.

Phase 1

Completed

Conditions: Breast Neoplasms
Stomach Neoplasms

Interventions: Drug: trastuzumab
Drug: Herceptin
Drug: afatinib

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

Phase 2

Completed

Conditions: Unilateral HER2 Positive Breast Cancer

Interventions: Drug: Afatinib
Drug: Trastuzumab
Drug: Paclitaxel
Drug: Epirubicin
Drug: Cyclophosphamide

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

Drug Development Updates

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