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

A Study of HER2+ Breast Cancer Patients With Active Brain Metastases Treated With Afatinib & T-DM1 vs. T-DM1 Alone

Phase 2

Conditions: Brain Metastases
HER2-positive Breast Cancer

Interventions: Drug: Afatinib
Drug: T-DM1

First Posted Date: 2019-11-12

Last Posted Date: 2020-05-12

Lead Sponsor: xuexin he

Target Recruit Count: 130

Registration Number: NCT04158947

Locations: 🇨🇳
Peking University International Hospital, Beijing, Beijing, China
🇨🇳
Sun Yat-sen University Cancer Center (SYSUCC), Guangzhou, Guangdong, China
🇨🇳
Kiang Wu Hospital, Macao, Macao, China

and more 1 locations

To Evaluate the Efficacy of Afatinib in Advanced Lung Squamous Cell Carcinoma With EGFR Sensitive Mutation

Phase 4

Conditions: Lung Squamous Cell Carcinoma

Interventions: Drug: Afatinib

First Posted Date: 2019-10-18

Last Posted Date: 2019-10-29

Lead Sponsor: Shanghai Chest Hospital

Target Recruit Count: 20

Registration Number: NCT04132102

Locations: 🇨🇳
Shanghai Chest Hospital, Shanghai, Shanghai, China

Afatinib in Previously Treated ESCC With EGFR Overexpression or EGFR Amplification (ESCC-A01)

Phase 2

Conditions: Esophageal Squamous Cell Carcinoma

Interventions: Drug: Afatinib

First Posted Date: 2019-05-07

Last Posted Date: 2019-06-11

Lead Sponsor: Peking University

Target Recruit Count: 40

Registration Number: NCT03940976

Locations: 🇨🇳
Peking University Cancer Hospital and Institute, Beijing, Beijing, China

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Phase 1

Terminated

Conditions: Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Anatomic Stage IV Breast Cancer AJCC v8
Anemia
Ann Arbor Stage III Hodgkin Lymphoma
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Castration-Resistant Prostate Carcinoma

Interventions: Drug: Abemaciclib
Drug: Abiraterone
Drug: Afatinib
Biological: Bevacizumab
Drug: Bicalutamide
Procedure: Biospecimen Collection
Drug: Bortezomib
Drug: Cabazitaxel
Drug: Cabozantinib
Drug: Capecitabine
Drug: Carboplatin
Drug: Celecoxib
Drug: Cobimetinib
Drug: Copanlisib
Drug: Dabrafenib
Drug: Dacomitinib
Drug: Darolutamide
Drug: Dasatinib
Drug: Doxorubicin
Biological: Durvalumab
Drug: Enasidenib
Drug: Entrectinib
Drug: Enzalutamide
Drug: Erlotinib
Drug: Everolimus
Drug: Fluorouracil
Drug: Idelalisib
Drug: Imatinib
Biological: Ipilimumab
Drug: Lenvatinib
Drug: Leucovorin
Drug: Lorlatinib
Drug: Losartan
Drug: Nab-paclitaxel
Drug: Neratinib
Biological: Nivolumab
Drug: Olaparib
Drug: Oxaliplatin
Drug: Palbociclib
Drug: Panobinostat
Biological: Pembrolizumab
Biological: Pertuzumab
Drug: Ponatinib
Other: Quality-of-Life Assessment
Drug: Regorafenib
Drug: Ruxolitinib
Drug: Sirolimus
Drug: Sorafenib
Drug: Sunitinib
Drug: Trametinib
Biological: Trastuzumab Emtansine
Drug: Tretinoin
Drug: Vemurafenib
Drug: Venetoclax
Drug: Vismodegib
Drug: Vorinostat

First Posted Date: 2019-03-18

Last Posted Date: 2024-03-04

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 2

Registration Number: NCT03878524

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma

Phase 1

Active, not recruiting

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Afatinib
Drug: Talcum powder

First Posted Date: 2019-02-01

Last Posted Date: 2023-04-25

Lead Sponsor: Center Trials & Treatment Europe

Target Recruit Count: 12

Registration Number: NCT03827070

Locations: 🇬🇪
Central Contact, Tbilisi, Georgia

An Explorative Study of Afatinib in the Treatment of Advanced Cancer Carrying an EGFR, a HER2 or a HER3 Mutation

Phase 2

Conditions: Cancers Harbouring an EGFR Mutation, (Excluding Non-squamous Non- Small Cell Lung Cancer, a Registered Indication), a HER2 Mutation or a HER3 Mutation

Interventions: Drug: Afatinib
Drug: Paclitaxel

First Posted Date: 2019-01-22

Last Posted Date: 2019-01-22

Lead Sponsor: AZ-VUB

Target Recruit Count: 87

Registration Number: NCT03810872

Locations: 🇧🇪
Les Cliniques Universitaires St Luc, Brussels, Belgium
🇧🇪
CHU Sart-Tilman, Liège, Belgium
🇧🇪
Institut Jules Bordet, Brussels, Belgium

and more 2 locations

Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1

Phase 1

Recruiting

Conditions: Advanced Cancer
Metastatic Cancer
Malignant Neoplastic Disease

Interventions: Drug: MRTX849
Drug: Pembrolizumab
Drug: Cetuximab
Drug: Afatinib

First Posted Date: 2018-12-24

Last Posted Date: 2024-06-21

Lead Sponsor: Mirati Therapeutics Inc.

Target Recruit Count: 822

Registration Number: NCT03785249

Locations: 🇺🇸
Local Institution - 001-873-A, Tucson, Arizona, United States
🇺🇸
Local Institution - 001-840-B, Bellflower, California, United States
🇺🇸
Local Institution - 001-850-K, Dublin, California, United States

and more 211 locations

Afatinib and Cetuximab in Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Positive Non-small-cell Lung Cancer

Phase 2

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Afatinib
Drug: Cetuximab

First Posted Date: 2018-11-01

Last Posted Date: 2023-10-18

Lead Sponsor: The Netherlands Cancer Institute

Target Recruit Count: 37

Registration Number: NCT03727724

Locations: 🇳🇱
Antoni van Leeuwenhoek, Amsterdam, North-Holland, Netherlands
🇳🇱
VU Medical Center, Amsterdam, Netherlands
🇳🇱
Maastricht UMC+, Maastricht, Netherlands

and more 1 locations

Afatinib on CNS Metastases and LMD in EGFR Mutation Positive NSCLC

Phase 1

Terminated

Conditions: Non-small Cell Lung Cancer
Leptomeningeal Disease
Central Nervous System Metastases

Interventions: Drug: Afatinib

First Posted Date: 2018-10-18

Last Posted Date: 2022-06-14

Lead Sponsor: National Cancer Centre, Singapore

Target Recruit Count: 2

Registration Number: NCT03711422

Locations: 🇸🇬
National Cancer Center Singapore, Singapore, Singapore

Afatinib and Nivolumab as Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Phase 1

Withdrawn

Conditions: Metastatic Squamous Cell Carcinoma of the Head or Neck
Squamous Cell Carcinoma
Recurrent Squamous Cell Carcinoma of the Head or Neck

Interventions: Drug: Nivolumab
Drug: Afatinib

First Posted Date: 2018-08-29

Last Posted Date: 2019-06-20

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Registration Number: NCT03652233

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