Dacomitinib

Generic Name: Dacomitinib

Brand Names: Vizimpro

Drug Type: Small Molecule

Chemical Formula: C_₂₄H_₂₅ClFN_₅O_₂

CAS Number: 1110813-31-4

Unique Ingredient Identifier: 2XJX250C20

Background: Dacomitinib, designed as (2E)-N-16-4-(piperidin-1-yl) but-2-enamide, is an oral highly selective quinazalone part of the second-generation tyrosine kinase inhibitors which are characterized by the irreversible binding at the ATP domain of the epidermal growth factor receptor family kinase domains.
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Indication: Dacomitinib is indicated as the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as verified by an FDA-approved test.
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Associated Conditions: Metastatic Non-Small Cell Lung Cancer

Associated Therapies: -

Clinical Trials

Phase 2 Study of Dacomitinib in NSCLC

Phase 2

Active, not recruiting

Conditions: Recurrent NSCLC
NSCLC Stage IIIB
NSCLC Stage IIIC
NSCLC Stage IV
EGFR Positive Non-Small Cell Lung Cancer

Interventions: Drug: Dacomitinib

First Posted Date: 2019-07-22

Last Posted Date: 2024-02-01

Lead Sponsor: National Cancer Centre, Singapore

Target Recruit Count: 118

Registration Number: NCT04027647

Locations: 🇲🇾
University Malaya Medical Centre, Kuala Lumpur, Malaysia
🇲🇾
Sarawak General Hospital, Kuching, Sarawak, Malaysia
🇲🇾
Beacon Hospital, Petaling Jaya, Malaysia

and more 6 locations

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

Evaluate Severe Hepatic Impairment on Dacomitinib PK

Phase 1

Completed

Conditions: Severe Hepatic Impairment

Interventions: Drug: Dacomitinib

First Posted Date: 2019-03-06

Last Posted Date: 2020-11-06

Lead Sponsor: Pfizer

Target Recruit Count: 16

Registration Number: NCT03865446

Locations: 🇺🇸
Investigational Drug Services (IDS) University of Miami Hospitals and Clinics, Research Pharmacy, Miami, Florida, United States
🇺🇸
University of Miami Division of Clinical Pharmacology, Miami, Florida, United States
🇺🇸
Orlando Clinical Research Center, Orlando, Florida, United States

Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer

Phase 1

Active, not recruiting

Conditions: Metastatic Non-small Cell Lung Cancer

Interventions: Drug: Dacomitinib
Drug: Osimertinib

First Posted Date: 2019-01-22

Last Posted Date: 2024-02-02

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 22

Registration Number: NCT03810807

Locations: 🇺🇸
Memorial Sloan Kettering Westchester, Harrison, New York, United States
🇺🇸
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

and more 4 locations

A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.

Early Phase 1

Completed

Conditions: EGFR Gene Mutation
Lung Cancer Metastatic
Lung Cancer

Interventions: Drug: Dacomitinib
Drug: Osimertinib

First Posted Date: 2018-11-27

Last Posted Date: 2023-07-12

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 17

Registration Number: NCT03755102

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States

and more 5 locations

The Drug Rediscovery Protocol (DRUP Trial)

First Posted Date: 2016-10-05

Last Posted Date: 2024-01-24

Lead Sponsor: The Netherlands Cancer Institute

Target Recruit Count: 1550

Registration Number: NCT02925234

Locations: 🇳🇱
Meander medisch centrum, Amersfoort, Netherlands
🇳🇱
Netherlands Cancer Institute, Amsterdam, Netherlands
🇳🇱
Amsterdam UMC, locatie AMC, Amsterdam, Netherlands

and more 33 locations

A Rollover Protocol of Dacomitinib For Patients In Japan

Phase 2

Completed

Conditions: NSCLC

Interventions: Drug: Dacomitinib

First Posted Date: 2015-03-09

Last Posted Date: 2020-07-02

Lead Sponsor: Pfizer

Target Recruit Count: 7

Registration Number: NCT02382796

Locations: 🇯🇵
Kanazawa University Hospital, Kanazawa City, Ishikawa, Japan
🇯🇵
Kurashiki Central Hospital, Kurashiki, Okayama, Japan
🇯🇵
Osaka City General Hospital Department of Clinical Oncology, Osaka-city, Osaka, Japan

and more 3 locations

Efficacy and Safety of Dacomitinib in the Treatment of Skin Squamous Cell Cancer

Phase 2

Conditions: Skin Squamous Cell Cancer

Interventions: Drug: Dacomitinib

First Posted Date: 2014-10-20

Last Posted Date: 2016-07-04

Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Target Recruit Count: 43

Registration Number: NCT02268747

Locations: 🇮🇹
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Milan, Italy

Dacomitinib (PF-00299804) Pharmacokinetics In Chinese Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dacomitinib

First Posted Date: 2014-03-27

Last Posted Date: 2014-10-03

Lead Sponsor: Pfizer

Target Recruit Count: 14

Registration Number: NCT02097433

Locations: 🇨🇳
Peking Union Medical College Hospital, Beijing, China

A Phase II Study of Dacomitinib in Progressive Brain Metastases

Phase 2

Terminated

Conditions: Brain Cancer

Interventions: Drug: Dacomitinib

First Posted Date: 2014-01-28

Last Posted Date: 2016-09-22

Lead Sponsor: David Piccioni, M.D., Ph.D

Target Recruit Count: 4

Registration Number: NCT02047747

Locations: 🇺🇸
UCSD Moores Cancer Center, La Jolla, California, United States

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