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

Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE)

Phase 2

Terminated

Conditions: Non-small-cell Lung Cancer With Somatic EGFR Mutations

Interventions: Drug: Afatinib
Drug: Pemetrexed

First Posted Date: 2015-11-04

Last Posted Date: 2019-04-19

Lead Sponsor: Universität Duisburg-Essen

Target Recruit Count: 4

Registration Number: NCT02595840

Trial Using Gilotrif for Advanced Penile Squamous Cell Carcinoma

Phase 2

Terminated

Conditions: Penile Squamous Cell Carcinoma (PSCC)

Interventions: Drug: Gilotrif

First Posted Date: 2015-09-04

Last Posted Date: 2020-04-14

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 8

Registration Number: NCT02541903

Locations: 🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸
University of Southern California, Los Angeles, California, United States

Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older

Phase 4

Completed

Conditions: Carcinoma, Non-Small-Cell Lung
ErbB Receptors

Interventions: Drug: Afatinib

First Posted Date: 2015-08-03

Last Posted Date: 2020-03-30

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 25

Registration Number: NCT02514174

Locations: 🇺🇸
Pacific Cancer Medical Center, Inc., Anaheim, California, United States
🇺🇸
Baystate Health D'Amour Center for Cancer Care, Springfield, Massachusetts, United States
🇺🇸
Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc., Fountain Valley, California, United States

and more 7 locations

Trial of Afatinib With Paclitaxel for Neoadjuvant Therapy of TNBC and Research of Biomarkers of Afatinib

Phase 2

Conditions: Triple Negative Breast Cancer

Interventions: Drug: Afatinib

First Posted Date: 2015-07-30

Last Posted Date: 2016-04-15

Lead Sponsor: National Taiwan University Hospital

Target Recruit Count: 40

Registration Number: NCT02511847

Locations: 🇨🇳
National Taiwan University Hospital, Taipei City, Taiwan

A Study of Afatinib in Patients With Advanced Cancer With Changes in the HER Gene

Phase 2

Completed

Conditions: Solid Tumors

Interventions: Drug: Afatinib

First Posted Date: 2015-07-23

Last Posted Date: 2023-08-01

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 12

Registration Number: NCT02506517

Locations: 🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Afatinib, Paclitaxel, 2nd Line, Advanced Gastric Cancer

Phase 2

Completed

Conditions: Gastroesophageal Junction Cancer
Gastric Cancer

Interventions: Drug: afatinib
Drug: paclitaxel

First Posted Date: 2015-07-17

Last Posted Date: 2023-01-27

Lead Sponsor: Yonsei University

Target Recruit Count: 72

Registration Number: NCT02501603

Locations: 🇰🇷
Severance Hospital, Yonsei University Health System, Yonsei Cancer Center, Seoul, Korea, Republic of

A Phase II Evaluation of Afatinib in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma

Phase 2

Recruiting

Conditions: HER2/Neu+ Uterine Serous Carcinoma

Interventions: Drug: Afatinib

First Posted Date: 2015-07-07

Last Posted Date: 2024-08-20

Lead Sponsor: Yale University

Target Recruit Count: 50

Registration Number: NCT02491099

Locations: 🇺🇸
University of Arizona Cancer Center, Tucson, Arizona, United States
🇺🇸
Yale New Haven Hospital, New Haven, Connecticut, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States

Maintaining ERBB Blockade in EGFR-mutated Lung Cancer

Phase 2

Terminated

Conditions: Non-small-cell Lung Cancer With Somatic EGFR Mutations

Interventions: Drug: Pemetrexed
Drug: Afatinib

First Posted Date: 2015-07-02

Last Posted Date: 2018-01-09

Lead Sponsor: AIO-Studien-gGmbH

Target Recruit Count: 4

Registration Number: NCT02488694

Locations: 🇩🇪
Universitätsklinikum Essen, Essen, Germany

Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer.

Phase 2

Suspended

Conditions: Non Small Cell Lung Cancer

Interventions: Procedure: Immediate surgery
Drug: Afatinib

First Posted Date: 2015-06-12

Last Posted Date: 2016-01-22

Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Target Recruit Count: 38

Registration Number: NCT02470065

Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)

Phase 2

Active, not recruiting

Conditions: Advanced Malignant Solid Neoplasm
Breast Carcinoma
Cervical Carcinoma
Liver Carcinoma
Malignant Uterine Neoplasm
Recurrent Gastric Carcinoma
Recurrent Head and Neck Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Prostate Carcinoma
Recurrent Rectal Carcinoma

Interventions: Drug: Afatinib
Drug: Capivasertib
Drug: Binimetinib
Drug: Adavosertib
Procedure: Biospecimen Collection
Other: Cytology Specimen Collection Procedure
Drug: Afatinib Dimaleate
Drug: Dabrafenib
Drug: Defactinib
Drug: Fexagratinib
Drug: Dasatinib
Drug: Ipatasertib
Procedure: Biopsy
Drug: Crizotinib
Drug: Dabrafenib Mesylate
Drug: Taselisib
Drug: Sapanisertib
Drug: PI3K-beta Inhibitor GSK2636771
Drug: Defactinib Hydrochloride
Drug: Palbociclib
Biological: Nivolumab
Drug: Copanlisib
Drug: Ulixertinib
Biological: Trastuzumab Emtansine
Drug: Copanlisib Hydrochloride
Biological: Relatlimab
Procedure: Computed Tomography
Drug: Trametinib
Biological: Pertuzumab
Drug: Erdafitinib
Procedure: Radiologic Examination
Procedure: Multigated Acquisition Scan
Drug: Larotrectinib
Procedure: Echocardiography
Drug: Osimertinib
Biological: Trastuzumab
Drug: Larotrectinib Sulfate
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Drug: Vismodegib
Drug: Sunitinib Malate
Procedure: Radionuclide Imaging

First Posted Date: 2015-06-08

Last Posted Date: 2024-12-19

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 6452

Registration Number: NCT02465060

Locations: 🇺🇸
Alaska Women's Cancer Care, Anchorage, Alaska, United States
🇺🇸
Anchorage Oncology Centre, Anchorage, Alaska, United States
🇺🇸
Katmai Oncology Group, Anchorage, Alaska, United States

and more 1416 locations

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