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 ...

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 Trials

LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy

Phase 3

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: afatinib
Drug: erlotinib

First Posted Date: 2012-02-01

Last Posted Date: 2019-02-15

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 795

Registration Number: NCT01523587

Locations: 🇭🇺
Pulmonology Institute of Veszprem County, Farkasgyepu, Farkasgyepü, Hungary
🇮🇳
Sri Ramachandra Medical College & Research Institute, Chennai, India
🇮🇳
B. P .Poddar Hospital & Medical Research Ltd., Kolkata, West Bengal, India

and more 187 locations

LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung

Phase 2

Completed

Conditions: Lung Neoplasms

Interventions: Drug: Afatinib
Drug: gefitinib

First Posted Date: 2011-11-08

Last Posted Date: 2020-04-07

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 319

Registration Number: NCT01466660

Locations: 🇫🇷
CTR Leon Berard, Lyon, France
🇬🇧
Western General Hospital, Edinburgh, United Kingdom
🇨🇳
Cancer Hospital of Chinese Academy of Medical Science, Beijing, China

and more 60 locations

Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases

Phase 2

Completed

Conditions: Breast Neoplasms
Neoplasm Metastasis

Interventions: Drug: Investigator's choice of treatment
Drug: afatinib
Drug: Vinorelbine

First Posted Date: 2011-09-27

Last Posted Date: 2015-09-07

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 121

Registration Number: NCT01441596

Locations: 🇰🇷
1200.67.82002 Boehringer Ingelheim Investigational Site, Seoul, Korea, Republic of
🇺🇸
1200.67.10105 Boehringer Ingelheim Investigational Site, Fullerton, California, United States
🇺🇸
1200.67.10108 Boehringer Ingelheim Investigational Site, Santa Barbara, California, United States

and more 37 locations

Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: afatinib
Drug: ritonavir + afatinib

First Posted Date: 2011-09-01

Last Posted Date: 2014-06-09

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 24

Registration Number: NCT01426958

Locations: 🇩🇪
1200.151.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

Evaluation of Afatinib in Maintenance Therapy in Squamous Cell Carcinoma of the Head and Neck

Phase 3

Completed

Conditions: Head and Neck Squamous Cell Carcinoma

Interventions: Drug: AFATINIB
Drug: Placebo of AFATINIB

First Posted Date: 2011-09-01

Last Posted Date: 2021-06-01

Lead Sponsor: Centre Leon Berard

Target Recruit Count: 134

Registration Number: NCT01427478

Locations: 🇫🇷
Centre François Baclesse, Caen, France
🇫🇷
Centre Paul Papin, Angers, France
🇫🇷
CHU Bordeaux - Hôpital Saint-André, Bordeaux, France

and more 23 locations

Research of Biomarkers of Activity and Efficacy of BIBW2992 in Untreated Non-metastatic HNSCC Patients

Phase 2

Completed

Conditions: Carcinoma, Squamous Cell of Head and Neck

Interventions: Drug: Afatinib

First Posted Date: 2011-08-12

Last Posted Date: 2022-02-02

Lead Sponsor: UNICANCER

Target Recruit Count: 61

Registration Number: NCT01415674

Locations: 🇫🇷
CHU d'Angers, Angers, France
🇫🇷
Centre François Baclesse, Caen, France
🇫🇷
Institut de cancérologie de l'Ouest - Site Paul Papin, Angers, France

and more 8 locations

Drug Interaction Study With Rifampicin and Afatinib

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Afatinib
Drug: Rifampicin

First Posted Date: 2011-07-18

Last Posted Date: 2014-06-09

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 22

Registration Number: NCT01396265

Locations: 🇩🇪
1200.152.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

Phase 3

Completed

Conditions: Head and Neck Neoplasms
Carcinoma, Squamous Cell

Interventions: Drug: Methotrexate
Drug: Afatinib

First Posted Date: 2011-05-02

Last Posted Date: 2018-02-15

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 483

Registration Number: NCT01345682

Locations: 🇯🇵
1200.43.08111 Boehringer Ingelheim Investigational Site, Hyogo, Akashi, Japan
🇯🇵
1200.43.08107 Boehringer Ingelheim Investigational Site, Hyogo, Kobe, Japan
🇫🇷
1200.43.03303 Boehringer Ingelheim Investigational Site, Lille Cedex, France

and more 98 locations

LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

Phase 3

Terminated

Conditions: Head and Neck Neoplasms

Interventions: Drug: Afatinib
Drug: Placebo

First Posted Date: 2011-05-02

Last Posted Date: 2017-12-07

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 617

Registration Number: NCT01345669

Locations: 🇧🇷
1200.131.05555 Boehringer Ingelheim Investigational Site, Jau, Brazil
🇦🇺
1200.131.06151 Boehringer Ingelheim Investigational Site, Wooloongabba, Queensland, Australia
🇦🇷
1200.131.05451 Boehringer Ingelheim Investigational Site, Ciudad Autonoma de Bs As, Argentina

and more 159 locations

Influence of Mild and Moderate Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Various Doses of Afatinib

Phase 1

Completed

Conditions: Healthy
Liver Diseases

Interventions: Drug: Afatinib

First Posted Date: 2011-02-17

Last Posted Date: 2013-12-31

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 35

Registration Number: NCT01298063

Locations: 🇩🇪
1200.86.1 Boehringer Ingelheim Investigational Site, Kiel, Germany

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